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Suggestions within category "Cancer"


78 Study Matches

Phase 1/2 Multicenter Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of APL-101 in Subjects with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors

This Phase 1 and 2 study is to determine the safety of APL-101 in subjects with NSCLC with specific mutations. It is also to determine the dose that is tolerable for oral administration of APL-101. And to see if there is a clinical benefit to subjects for the amount of time to progression, or progression free survival and overall survival.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-8678
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03175224
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Inclusion Criteria:
Phase 1, histologically and / or cytological confirmed unresectable or metastatic solid malignancy, refractory to standard therapies with no more than three prior lines of therapy
Women of child-bearing potential (WOCBP) must have a negative serum or β-human chorionic gonadotropin (β-hCG) at screening or evidence of surgical sterility or evidence of postmenopausal status.
Abnormal c-Met dysregulation, by tissue and/or plasma, defined as the following from local/archival molecular pre-screening evaluations.
Measurable disease according to RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0–1
Exclusion Criteria:
Hypersensitivity to APL-101, excipients of the drug product, or other components of the study treatment regimen.
Known mutation/gene rearrangement of EGFR (except for Cohort C), ALK, ROS1, RET, NTRK, KRAS, and BRAF.
Active uncontrolled systemic bacterial, viral, or fungal infection or clinically significant, active disease process
History of, or currently, or at risk for, cardiac disease (e.g., long QT syndrome [> 450 msec QTcF or concurrent treatment with any medication that prolongs QT interval).
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter drug absorption (e.g., Crohn’s, ulcerative colitis, active inflammatory bowel disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption sydrome).
Cancer
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Hershey, PA

GLNE 010: Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma

The purpose of this study is to see if stool, urine or blood can be used to find colon cancer as early or earlier than colonoscopy can. The researchers want to use these samples to learn about specific proteins or genes (also called biomarkers) that may indicate if someone has colon polyps (pre-cancer), colon cancer, or an increased risk for developing colon cancer. The researchers are part of a National Cancer Institute program called the Early Detection Research Network (EDRN). We have some biomarkers that are very promising, so we are testing them (“validating them”) in this study.
Amanda Taylor Gehman at ataylor6@pennstatehealth.psu.edu or 717-531-1283
All
18 year(s) or older
This study is also accepting healthy volunteers
NCT01511653
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Inclusion Criteria:
Scheduled for colonoscopy in the next 4 months
age 50 and older who are undergoing their first ever screening colonoscopy
adults age 70 and older with colonoscopy more than 9.5 years ago
willing to provide blood, urine and stool samples
able to tolerate removal of 5 tubes (3.5 tablespoons) of blood
Exclusion Criteria:
positive stool blood test (FIT/FOBT) in the past year
ever had colon or rectal cancer
history of inflammatory bowel disease
confirmed hereditary non-polyposis colorectal cancer, familial adenomatous polyposis, HIV or chronic viral hepatitis
cancer diagnosis or treatment in past year
Prevention, Digestive Systems & Liver Disease, Cancer
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Hershey, PA

Feasibility Study Phase C: Expansion in Multiple Institutions for Training in the Use of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects with Breast Cancer

The main goal of standardizing the training for surgeons and clinical staff that will be participating in the anticipated pivotal study of the Lumicell Imaging System. Identify and address any site-specific or user-specific issues for using the LUM Imaging System in breast cancer patients and to collect safety and efficacy data.
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02438358
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Inclusion Criteria:
Female, age of 18 years or older
Cytology confirmed primary invasive breast cancer, ductal carcinoma in situ or a combination of both
Scheduled for lumpectomy for a breast malignancy
No uncontrolled serious medical problems
Exclusion Criteria:
Subjects who are pregnant at the time of breast cancer diagnosis
Uncontrolled hypertension or other uncontrolled medical problems
Patient who is sexually active and not willing to use contraception-hormonal or barrier method, or abstinence for 60 days after injection
Individuals undergoing a second lumpectomy because of previous positive margins
Subjects who have taken an investigational drug in the 30 days prior to enrollement
Cancer, Women's Health
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Hershey, PA

An investigation of the daily experiences of cancer survivors preparing for follow-up appointments: An ecological momentary assessment study

Have you been diagnosed with cancer? Have you completed cancer treatment(s)? Have you scheduled or are you planning to schedule a follow-up appointment? We are trying to understand how follow-up appointments impact the everyday health and wellbeing of cancer survivors. We are seeking men and women (age 30-75) who have completed treatments for cancer (stages 0-3), and have a scheduled or plan to schedule a follow-up cancer screening appointment in the next 30 days. In this study, you will be asked to: - Attend two brief visits at the Penn State University Park Campus or Mount Nittany Medical Center - Carry around a smartphone for two weeks to answer brief surveys throughout your everyday life - Receive up to $160 compensation for your time If you are interested in learning more about this study or would like to find out if you are eligible, please contact our study team at (814) 865-9473 or email jaj53@psu.edu
Jillian Johnson at jaj53@psu.edu or 814-865-9473
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Adult (30-75)
Cancer diagnosis stage 0 through 3
Completed primary cancer treatment at least 3 months prior to participating
Have a scheduled or plan to schedule a follow-up cancer screening appointment in the next 30 days
Fluent in English
Exclusion Criteria:
No cancer diagnosis, or diagnosis of Stage 4 cancer
Under the age of 30 or over the age of 75
Diagnosis of psychiatric disorder AND recent hospitalization
Visual impairments that would prevent use of mobile device or computer use
Severe cognitive impairment
Cancer
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State College, PA

Site For 18-025, EA8143 A Phase 3 Study Comparing Perioperative Nivolumab Vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy

Site For 18-025, EA8143 A Phase 3 Study Comparing Perioperative Nivolumab Vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03055013
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Inclusion Criteria:
Newly Diagnosed higher risk RCC of any histology
No clinical or radiological evidence of distant metastases
No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted
Age must be greater than or equal to 18 years old
ECOG Performance status must be 0 or 1
Exclusion Criteria:
Women must not be pregant or breast feeding
History of RCC that was resected with curative intent within the past 5 years
Prior or current prostate cancer is excluded
Active known or suspected autoimmune disease
Uncontrolled adrenal insufficiency
Kidney & Urinary System, Cancer
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Hershey, PA

A Pilot Study to evaluate the pharmacokinetic, pharmacodynamic, and resistance profile to trametinib and dabrafenib in BRAF-V600E mutated recurrent gliomas

This research is being done to understand how much of two drugs (dabrafenib and trametinib) is able to enter brain tumors and how well the drugs are able to turn off this pathway in brain tumors. The study will also look at how tumors lose sensitivity to this treatment. People with primary brain tumors who are already taking dabrafenib and trametinib and who need a brain surgery are eligible for this study. Biospecimens (tissue, blood, and cerebrospinal fluid (CSF)) taken during the surgery will help us understand how much of these two study drugs actually get into the brain, their effect, and how the tumors become resistant to treatment.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
At least 18 years old
Subjects must have a history of primary brain tumor (including but not limited to glioblastoma (GBM), anaplastic astrocytoma (AA), anaplastic ganglioglioma (AG), and anaplastic pleomorphic xanthoastrocytoma (PXA)).
Subjects must have a BRAF-V600 mutation identified in previous tissue analysis (may be IHC or PCR based). Allowable mutations include V600E, V600K, V600R, and V600D.
Subjects must be taking dabrafenib at a dose of at least 50mg twice daily (adults only) and / or trametinib at a dose of at least 1mg daily (adults only) for at least 7 days prior to surgery as prescribed by their treating physician.
Subjects must be undergoing surgery for clinical purposes
Exclusion Criteria:
Younger than 18 year old
Subjects who are receiving any other investigational agents or chemotherapeutic agents.
Neurology, Cancer
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Hershey, PA

A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer: Big Ten Cancer Research Consortium (BTCRC-BRE15-016) (16-053)

Primary Objective The primary objective of the Phase II study is to estimate the activity of the combination of palbociclib and tamoxifen in first line therapy for women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease, assessed by response rates (complete or partial response) (RR) based on RECIST 1.1 or MDA criteria (for patients with bone only disease). Secondary Objectives - Characterize safety and tolerability of palbociclib and tamoxifen in first line therapy for women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease. - Evaluate progression-free survival (PFS) per local assessment and RECIST 1.1 or MDA criteria in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen. - Evaluate clinical benefit rate RR (complete, partial response, or stable disease, lasting 24 weeks or longer) based on RECIST 1.1 or MDA criteria in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen. - Measure overall survival (OS) at 2 years in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02668666
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Inclusion Criteria:
Locally advanced, locoregionally recurrent, or metastatic disease, not amenable to curative therapy
Histologically and/or cytologically confirmed diagnosis of ER positive and/or PR positive (ER>1%, PR>1%), Her2 negative breast cancer
No prior systemic anti-cancer therapy for advanced HR+ positive disease
Metastatic disease evaluable on imaging studies.
Adequate blood, liver and kidney function
Exclusion Criteria:
Prior treatment with any CDK 4/6 inhibitor
Confirmed diagnosis of HER2 positive disease
Known uncontrolled or symptomatic CNS metastases.
Prior (neo)adjuvant treatment with tamoxifen within the 12 months before study entry.
Prior history of blood clots, pulmonary embolism or deep vein thrombosis.
Cancer
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Hershey, PA

Site for A Phase III Randomized Trial Comparing Adjuvant MK3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma

The purpose of this Phase III study is to compare Overall Survival (OS) and Recurrence Free Survival (RFS) across the two arms: MK3475 (Pembrolizumab) to Standard of Care Observation. Patients will undergo standard clinical procedures including physical, labs, vitals, ecg's, and imaging.
Irina Geier at iug29@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03712605
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Inclusion Criteria:
Patients must have an ECOG performance Status: 0, 1, or 2
Patient must have a histological confirmation of diagnosis of Merkel cell carcinoma (MCC), pathologic stages (AJCC version 8) I-IIIb.
completely resected by surgery within 8 weeks before enrollment.
All patients must have disease-free status documented by a complete physical examination and conventional imaging studies within 4 weeks prior to randomization.
Patients must not be on active immunosuppression, have a history of life threating virus, have had other cancer diagnoses in the last two years
Exclusion Criteria:
Women who are pregnant
present metastases
previous systemic therapy or radiation therapy for Merkel cell carcinoma.
inoperable disease who have received radiation are not eligible.
history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
Cancer
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Hershey, PA

A Phase 2b, Single-Arm, Multicenter Trial to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients with Low Grade (LG) Non-Muscle-Invasive Bladder Cancer (NMIBC) at Intermediate Risk of Recurrence

This study is for patients with bladder cancer (low-grade non-muscle-invasive) who are at an intermediate risk of recurrence. The purpose of this study is to evaluate the effectiveness and safety of an experimental gel which will serve as a reservoir for a more prolonged release of a type of chemotherapy locally in the bladder.
Kathleen Lehman at klehman3@pennstatehealth.psu.edu or 717-531-5930
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03558503
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Inclusion Criteria:
Newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at screening or within 6 weeks of screening
At intermediate risk for progression, defined as having 1 or 2 of the following: a. presence of multiple tumors, b. solitary tumor >3 cm c. recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis).
Negative voiding cytology for HG disease at or within 6 weeks of enrollment.
Exclusion Criteria:
History of CIS on preliminary cystoscopy within 5 years of enrollment.
Received BCG treatment for UC within previous 2 years.
History of HG papillary UC in the past [2] years
History of pelvic radiotherapy.
Past or current muscle invasive (i.e., T2, T3, T4) or metastatic UC or concurrent upper tract urothelial carcinoma (UTUC).
Kidney & Urinary System, Cancer
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Hershey, PA

Phase II Trial of Palbociclib with Fulvestrant in Individuals with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer who have Progressed on Treatment with Palbociclib and an Aromatase Inhibitor

In this phase II trial, we will determine the progression-free survival (PFS) of the cyclin dependent kinase 4/6 inhibitor (CDK4/6i) palbociclib with fulvestrant in women and men with estrogen or progesterone receptor (ER/PR) positive, HER2-negative metastatic breast cancer (MBC) who progressed on treatment with palbociclib and an aromatase inhibitor (AI). We will also determine the prevalence rate of estrogen eceptor α (ESR1) and phosphatidylinositol-3-kinase (PI3K) mutations in the study population.
Lea May at lmay1@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02738866
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Inclusion Criteria:
Men and women, 18 years of age or older
Histologically or cytologically confirmed adenocarcinoma of the breast with evidence of metastatic disease (stage IV) or locally advanced disease,
ER-positive and/or PR-positive tumor (≥1% positive stained cells) • HER2-negative tumor
Progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy for advanced/metastatic breast cancer, and be able and willing to receive additional palbociclib treatment
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Exclusion Criteria:
Women who are pregnant or breast-feeding
Concurrent use of any of the following medications during study participation: • Inhibitors or inducers of CYP3A4 that may affect serum concentrations of palbociclib
Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before registration.
Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
Prior hematopoietic stem cell or bone marrow transplantation.
Cancer
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Hershey, PA

Comparing barriers to cancer screening across PSCI catchment area county types: Implications for a self-sampling intervention – Patient surveys

In this study, we will conduct surveys with women, ages 45-65 years, who are patients in the Penn State Cancer Institute (PSCI) catchment area which includes rural/urban and segregated/not segregated counties in Pennsylvania to learn more about their barriers to cancer screening.
Female
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Female residing within the PSCI catchment area
45-65 years of age
Able to speak, read, and communicate well in English
Exclusion Criteria:
Children
Cognitively impaired
Cancer, Women's Health
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A Phase I/II, Multicenter, Open Label, Multi Arm Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Preliminary Activity Of Idasanutlin In Combination With Either Chemotherapy Or Venetoclax In The Treatment Of Pediatric And Young Adult Patients With Relapsed/Refractory Acute Leukemias Or Solid Tumors

A study of the safety of idasanutlin for children with solid tumors and leukemias that returned or did not respond to previous treatment.
Suzanne Treadway at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT04029688
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Inclusion Criteria:
1-30 year of age
Have a solid tumors or leukemia that returned or did not respond to previous treatment
Exclusion Criteria:
Have a primary CNS tumor
Have uncontrolled infection
Cancer
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Hershey, PA

PSCI-18-052 A Phase II Study to Evaluate the Response and Tolerability of Verzenio (Abemaciclib) in Patients with Advanced Biliary Tract Carcinoma who have Failed Prior Chemotherapy

The prognosis of patients with recurrent, late-stage inoperable, or progressed biliary tract carcinoma (BTC) is generally poor. The goal of this clinical study is to determine the effectiveness and safety of abemaciclib in patients with late-stage or progressed BTC that has failed one line of chemotherapy.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-4300
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04003896
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Inclusion Criteria:
Histologic or cytologic evidence of advanced or metastatic biliary tract cancer including cholangiocarcinoma (intra-hepatic or extra-hepatic bile ducts), ampullary carcinoma, and gallbladder carcinoma.
Evidence of recurrent, locally advanced, or metastatic disease.
Progressed following or intolerant to one or more line of systemic therapy.
Presence of at least 1 lesion that is measurable or evaluable using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Adequate organ function, as evidenced by the laboratory parameters noted in Study Eligibility.
Exclusion Criteria:
Ongoing or active infection requiring systemic antibiotics.
History of previous venous thromboembolic events.
Uncontrolled hypertension despite adequate therapy (i.e., systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 90 mm Hg found on 2 separate occasions separated by 1 week).
Diabetes mellitus and occurrence of more than 2 episodes of ketoacidosis in the 12 months prior to the first dose of study drug.
Active second malignancy other than curatively resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ carcinoma of the cervix, or other cancers with no known active disease in the 3 years prior to enrollment.
Cancer
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Hershey, PA

A Phase III Randomized Open Label Study to Compare NKTR-214 Combined with Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients with Previously Untreated Advanced Renal Cell Carcinoma (PSCI 18-122)

The purpose of the study is to compare how well the drug called NKTR-214 works when combined with the other drugs: nivolumab, sunitinib, and cabozantinib in patients with renal cell carcinoma.
Kathleen Rizzo at krizzo@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03729245
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Inclusion Criteria:
18 years or older
Karnofsky Performance Status of at least 70
advanced or metastatic renal carcinoma
No prior systemic therapy
No active brain metastases
Exclusion Criteria:
Use of an investigational agent or an investigational device within 28 days of randomization
autoimmune disease
History of organ or tissue transplant
Prior major surgery or radiotherapy within 14 days
Any tumor invading the major blood vessels
Cancer
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Hershey, PA

Site for Phase III Randomized Trial of Concurrent Chemoradiotherapy with or without Atezolizumab in Localized Muscle Invasive Bladder Cancer (Study SWOG/NRG 1806) (PSCI#19-044)

The purpose of this study is to compare the effects, good and/or bad, of chemotherapy and radiation therapy with or without the use of atezolizumab, which is used to treat bladder cancer. The combination of chemotherapy, radiation therapy and the immunotherapy atezolizumab is considered experimental. If you decide to take part in this study, you will receive combined chemotherapy and radiation therapy which is called “chemoradiotherapy” either with or without the study drug. The chemoradiotherapy you will receive is standard of care and what your doctor thinks is best. You will receive chemoradiotherapy for up to 7 weeks. If you are assigned to the group receiving study drug, you will take the drug for up to 6 months in addition the chemoradiotherapy. Your doctor will continue to follow your condition for up to 5 years after you register to the study, even though you have finished treatment in the first year. Your doctor will watch you for side effects and to see how your cancer affects you. You will have clinic visits at 3 months from the time you stop taking treatment for the first two years and then twice a year for the third year and once a year thereafter until 5 years after you register to the study.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03775265
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Inclusion Criteria:
Patients must have histologically proven, T2-T4a N0M0 urothelial carcinoma of the bladder within 70 days prior to randomization.
Patients must undergo radiological staging within 70 days prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must not have evidence of T4bN1-3 disease.
Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified.
Female patients of childbearing potential must have a serum pregnancy test prior to randomization.
Patients must be ≥ 18 years of age.
Exclusion Criteria:
Patient must not have received any systemic chemotherapy for their bladder cancer.
Patients must not have received prior treatment for muscle invasive bladder cancer including neoadjuvant chemotherapy for the current tumor.
Patients must not have a major surgical procedure within 28 days prior to randomization.
Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation.
Patients must have adequate bone marrow function as evidenced by all of the following: ANC ≥ 1,500/microliter (mcL); platelets ≥ 100,000/mcL; Hemoglobin ≥ 9 g/dL. These results must be obtained within 28 days prior to randomization.
Cancer
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Hershey, PA

PSCI-17-085 Effect of Omega-3 Fatty Acid (EPA) and its Metabolites in Combination with Tyrosine Kinase Inhibitors (TKIs) in Chronic Myeloid Leukemia (CML) in Stable Chronic Phase

The purpose of this Phase I/II study is to evaluate the safety and efficacy of the combination of tyrosine kinase inhibitors (TKIs) and an omega-3 fatty acid (like fish oil) in patients with Chronic Myeloid Leukemia (CML).
Seema Naik at snaik@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04006847
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Inclusion Criteria:
Confirmed diagnosis of CML ≥ 18 months from diagnosis
Current concomitant treatment with TKI therapy (Imatinib, Dasatinib, Nilotinib or Bosutinib; excluding Ponatinib)
BCR-ABL PCR at stable molecular disease (e.g. MMR stable but not CMR) or b. Hematologic remission (HR) but no MMR
Stable molecular response defined as 2 sequential BCR-ABL levels done in the same lab with less than ½ log reduction of BCR-ABL (BA)
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score more than or equal to 3
Exclusion Criteria:
Current malignancy requiring active treatment
Active infection requiring antibiotic treatment
Known HIV, Hepatitis B, or Hepatitis C infection
Known symptomatic congestive heart failure (CHF), unstable angina or cardiac arrhythmia
Current concomitant use of NSAIDs (including Aspirin) or COX-1; a washout period of 4 weeks prior to enrollment is permitted
Cancer
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Hershey, PA

Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia (AML) (PrE0905)

The purpose of this study is to compare the effectiveness of gilteritinib to midostaurin in patients receiving standard combination chemotherapy for a particular change in AML of their leukemia cells (called a mutation) in a gene called FLT3.
Lea Russell at lrussell@pennstatehealth.psu.edu or 717-531-8678
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03836209
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Inclusion Criteria:
AML with FLT3 mutation status (includes signal ratio)
Verified confirmation that blasts are myeloid
Verified NPM1 mutation status
Must have an ECOG performance status of 0-3
Must have adequate organ function as measured by criteria
Exclusion Criteria:
May not have M3 AML
May not have known active Central Nervous System (CNS) leukemia
Not a woman of childbearing potential (WOCBP) or who agrees to follow the contraceptive guidance
May not have a history of Long QT Syndrome
May not have evidence of uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, or congestive heart failure
Cancer
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Hershey, PA

Phase I trial of Azacitidine Plus Nivolumab Following Reduced-Intensity Allogeneic PBSC Transplantation for Patients with AML and High-risk Myelodysplasia Big Ten Cancer Research Consortium BTCRC-AML18-342 (PSCI# 19-085)

The purpose of this voluntary research study is to find the maximum safe dose of nivolumab alone, and of nivolumab combined with azacitidine after reduced-intensity allogeneic peripheral blood stem cell (PBSC) transplantation. Another purpose is to see how the study drugs affect different aspects of transplant such as infection and disease response. This research is being done to find out the maximum safe dose of nivolumab alone, and of nivolumab combined with azacitidine after reduced-intensity allogeneic peripheral blood stem cell (PBSC) transplantation. Another purpose is to see how the study drugs affect different aspects of transplant such as infection and disease response.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04128020
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Inclusion Criteria:
Patients aged 18-59 years at the time of consent who are judged not to be candidates for myeloablative allogeneic PBSC transplantation
Karnofsky performance status (KPS) ≥ 70%
Acute myeloid leukemia (AML) in first (CR1) or subsequent complete remission (CR2, CR3 or beyond), as defined by less than 5% blasts in the bone marrow and peripheral blood
Absolute neutrophil count (ANC) >1.5x109/l
AST and ALT <2.5 x upper limit of normal
Exclusion Criteria:
Active central nervous system (CNS) leukemia. Patients with prior CNS leukemia that is now in remission are eligible.
Prior allogeneic or autologous stem cell transplantation before current transplant
Use of bone marrow or cord blood as stem cell source
History of acute GvHD of any grade
Use of systemic corticosteroids within 28 days prior to registration (except for use as replacement for adrenal insuffiency).
Cancer
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Location
Hershey, PA

A Multicenter Phase 2, Open-Label Study of Intratumoral Tavokinogene Telseplasmid (tavo, pIL-12) plus Electroporation in Combination with Intravenous Pembrolizumab in Patients with Stage III/IV Melanoma who are Progressing on either Pembrolizumab or Nivolumab Treatment (PISCES)

The purpose of this voluntary research study is to find out what effects, good and/or bad, the combination of a type of gene therapy treatment called plasmid electroporation and pembrolizumab has on your cancer.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-8678
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03132675
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Inclusion Criteria:
Pathologically documented unresectable melanoma, American Joint Committee on Cancer (AJCC) version 8, Stage III or IV
Subjects must be refractory to anti-PD-1 monoclonal antibodies (pembrolizumab or nivolumab either as monotherapy or in combination with other approved checkpoint inhibitors or targeted therapies according to their approved label
Resolution/improvement of anti-PD1 mAb-related AEs (including immune related AEs; irAEs) back to Grade 0-1
BRAF V600 mutation-positive melanoma could have received standard of care targeted therapy for advanced or metastatic disease
Has a performance status of 0 or 1 on the ECOG Performance Scale
Exclusion Criteria:
Subject has disease that is suitable for local therapy administered with curative intent
Clinically active CNS metastases
Subject with a diagnosis of uveal melanoma
Subject who had an allogenic tissue/solid organ transplant
Subjects with electronic pacemakers or defibrillators
Cancer
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Hershey, PA

PEDS-PLAN – Pediatric Precision Laboratory Advanced Neuroblastoma Therapy

A study of the safety and feasibility of using molecularly guided therapy in combination with standard therapy followed by maintenance therapy with DFMO in patients with newly diagnosed high risk neuroblastoma.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT02559778
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Inclusion Criteria:
A confirmed diagnosis of neuroblastoma.
Must be 21 years of age or younger when diagnosed.
No prior systemic therapy with some exceptions.
Tumor samples will be obtained only in a non-significant risk manner and not solely for the purpose of the study.
Exclusion Criteria:
Receiving another study drug while on this study.
Female patients who are lactating are not eligible unless they agree not toe breast feed.
Children's Health, Cancer
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Hershey, PA

Communication preferences related to over screening for cancer among older adults

The overall objective of this study is to explore the perspectives of older adults on incorporating and communicating risks, benefits and life expectancy into cancer screening decisions. The findings from this study will inform development of an intervention to reduce over-screening for breast, cervical, or colorectal cancers among average risk older adults who are not recommended for screening by current guidelines based on age. Average risk, including age, is defined by screening recommendations. A person is at average risk if they have not had cancer (as defined in the exclusion criteria) or colorectal polyp (within 10 years) or breast biopsy (within 10 years) and they are within the age range. Our hypothesis is that subjects will be more willing to discuss cessation of regular cancer screening risks, benefits, and life expectancy are incorporated into an ongoing dialogue between provider and subject.
Sol Rodriguez-Colon at srodriguezcolon@pennstatehealth.psu.edu or 717-531-5190
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
65 years or older
Willing to participate in focus group discussion
Exclusion Criteria:
Diagnosed with non-skin cancer within the past 5 years
Prevention, Education, Cancer
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Hershey, PA
State College, PA

CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: A Prospective, Randomized, Double-blind, Multi-center Clinical Trial

This study seeks to verify the findings of the CHARM I pilot study by conducting a multi-center clinical trial. We hypothesize that: • Pancreatic cyst infusion with a specifically designed drug therapy cocktail following normal saline lavage will result in cyst destruction rates that do not significantly differ from those achieved by alcohol-based cyst treatment (ethanol lavage followed by infusion of the same chemotherapeutic cocktail). • The removal of alcohol from the procedure will decrease both serious and minor adverse event rates associated with pancreatic cyst treatment. • There may be molecular markers contained within the fluid of these cystic tumors which identify cysts that are favorable to or resistant to EUS-guided fine needle infusion using this drug combination. As such, we will test all treated cysts for 10 of the best known molecular markers for evaluation in post study analysis. We expect that administering a specifically designed chemotherapeutic cocktail without prior alcohol lavage will result in an equivalent rate of cyst resolution with fewer complications when compared to alcohol. The results of this study will provide important information about the most efficient and safest method for treating premalignant pancreatic cysts, an important step for treating these lesions with a minimally invasive technique and preventing their progression to cancer. Standard alternative treatment options for this patient group (if not taking part in this study) would be ongoing periodic radiographic monitoring with MR or CT imaging waiting for signs of cancer to develop or to consider surgical removal of the affected tissue.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03085004
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Inclusion Criteria:
Adult subjects over the age of 18.
Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which are consistent with a mucinous type cyst as per ASGE guidelines including indeterminate type cysts.
Ability to give written informed consent.
Capable of safely undergoing endoscopy with deep sedation or general anesthesia.
Exclusion Criteria:
Lesions which are consistent with a benign cyst by clinical, cytological, chemical, and radiographic evaluation as per ASGE guidelines37 (i.e., consistent with a pseudocyst or serous cystadenoma).
Known or suspected pancreatic cancer or pathologic lymphadenopathy.
Cysts with the following high risk features: main pancreatic duct dilation of > 5mm,epithelial type mural nodules , pathologically thick wall/septation (> 2mm)..
Septated cysts with > 4 compartments.
Confirmed pancreatitis within the last 3 months.
Digestive Systems & Liver Disease, Cancer
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Hershey, PA

Standard Chemotherapy versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients with Recurrent Glioblastoma Multiforme (GBM). CSCRGBM

The investigational purpose of this study is to screen chemotherapy drugs currently used for the care of recurrent glioblastoma (a form of brain cancer) and to determine the most effective treatment based on results from a chemosensitivity assay. Chemosensitivity drug assay refers to testing a patient's own cancer cells in the laboratory to drugs that are to be used to treat the patient's cancer. Following surgery, you will be treated either as per chemotherapy agents chosen by the physician or with chemotherapies as suggested by the results of the chemosensitivity testing. The study is looking to determine if patients treated with drugs predicted by the chemosensitivity test have better outcomes than patients treated with drugs chosen by the treating physician.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03632135
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Inclusion Criteria:
Histopathologically confirmed WHO grade IV recurrent astrocytoma (recurrent GBM)
Recurrent surgically resectable tumor
Estimated survival of at least 3 months;
Exclusion Criteria:
Subjects with newly diagnosed GBM
Pregnant women or nursing mothers cannot participate in the study. Women of childbearing age must have a negative pregnancy test within 72 hours prior to study entry.
Neurology, Cancer
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Hershey, PA

Impact of Perioperative Music on Quality of Life Measures and Biomarker Levels in Breast Cancer Patients

Music therapy could improve post-operative quality of life measures and these improvements may correlate with decreased salivary levels of biomarkers that when elevated, traditionally indicate stress, depression, sleep deprivation, and poorer outcomes. This study aims to determine both if music affects molecular mechanisms through measurement of clinical biomarkers as well as if there is an association with significant quality of life measures
Kristine Widders at kwidders@pennstatehealth.psu.edu or 717-531-8815
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Diagnosis of stage 0 to stage
breast cancer as classified by the American Joint Committee on Cancer
Undergoing a mastectomy or lumpectomy at Penn State Hershey Medical Center
Exclusion Criteria:
Difficulties hearing that prevent one from listening to music
Serious oral health or dental conditions
Patient who have undergone pre-operative chemotherapy or pre-operatively radiation therapy
Should not be taking supplements of melatonin or be taking corticosteroids
History of liver cancer, liver disease, or cirrhosis
Cancer
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Hershey, PA

A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-Androgen Therapy With Apalutamide in Recurrent Prostate Cancer

To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone.
Kathleen Rizzo at kar23@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03371719
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Inclusion Criteria:
Pathologically (histologically) proven diagnosis of prostate adenocarcinoma.
Post-prostatectomy patients with a detectable serum PSA (≥0.1, but ≤1.0 ng/mL) at study entry (within 90 days of Step 1 registration) a
pN0 or pNx
History/physical examination within 90 days prior to Step 1 registration
Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
Exclusion Criteria:
Definitive clinical, radiologic, or pathologic evidence of metastatic disease (M1) or lymph node involvement (N1)
Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
Prior systemic chemotherapy for the study cancer
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
Prior whole gland ablative therapy
Cancer
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Hershey, PA

A Phase Ib/11 Study of Propranolol with fixed-dose Pembrolizumab in Patients with Unresectable Stage III and Stage IV Melanoma

This research is being done to find out the safety of propranolol and, identify the maximum tolerated dose of propranolol that can be administered in combination with pembrolizumab in patients with unresectable stage III and stage IV melanoma. This study will evaluate this novel combination of pembrolizumab and propranolol to see what effect it may have on how your cancer responds to the treatment combination.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-4300
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03384836
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Inclusion Criteria:
Age >=18 years.
Participants must be newly diagnosed, treatment-naive with histologically confirmed stage IIIC unresectable melanoma or stage IV melanoma.
Have measurable disease per RECIST v1.1
Have an ECOG performance status 0-1
Exclusion Criteria:
Participants who have received previous immunotherapy for any cancer (excluding melanoma) including PD-1/PD-L1 inhibitors but not interferons and CTLA-4 inhibitors.
Participants with chronic autoimmune diseases
Other invasive cancers diagnosed < 3 years back that required systemic treatment. If diagnosed with other invasive cancer ≥ 3 years, should have complete recovery from all systemic toxicity except neuropathy and alopecia
Cancer
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Hershey, PA

Pivotal study of the LUM Imaging System for assisting intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer.

The objective of this prospective, multi-center, single-arm study is to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients in order to assist surgeons in reducing the rates of positive margins.
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03686215
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Inclusion Criteria:
Subjects must have histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or primary invasive breast cancer with a DCIS component.
Female, age of 18 years or older. Because no dosing or adverse event data are currently available on the use of LUM015 in subjects <18 years of age, children are excluded from this study.
Subjects must be scheduled for a lumpectomy for a breast malignancy.
Subjects must be able and willing to follow study procedures and instructions.
Subjects must have no uncontrolled serious medical problems except for the diagnosis of breast cancer, as per the exclusion criteria listed below.
Exclusion Criteria:
Subjects who are treated for bilateral breast cancer resection procedure.
Subjects who are pregnant at the time of diagnosis of their breast cancer.
Subjects who are sexually active and not willing/able to use 2 medically acceptable forms of contraception (hormonal, barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015.
Subjects who have taken an investigational drug within 30 days of enrollment.
Subjects who will have administration of methylene blue or any dye for sentinel lymph node mapping on the day of the surgery prior to imaging the lumpectomy cavity with the LUM Imaging Device.
Cancer
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Hershey, PA

Site for LungMAP: A MASTER PROTOCOL TO EVALUATE BIOMARKER-DRIVEN THERAPIES AND IMMUNOTHERAPIES IN PREVIOUSLY-TREATED NON-SMALL CELL LUNG CANCER

This is a screening study and there is no treatment. The purpose of this study is to collect blood samples to determine if you are able to participate in other LUNGMAP studies.
Irina Geier at iug29@psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
pathologically proven non-small cell lung cancer
at least one line of systemic therapy for any stage of disease
Patients with known EGFR sensitizing mutations, EGFR T790M mutation, ALK gene fusion, ROS 1 gene rearrangement, or BRAF V600E
Patients must have Zubrod performance status 0-1
Patients must be ≥ 18 years of age.
Exclusion Criteria:
Patients must be willing to provide prior smoking history as required on the LungMAP Onstudy Form.
Patients under age of 18
Criteria documentation within 28 days
n/a
n/a
Cancer
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Hershey, PA
Reading, PA

Comparing barriers to cancer screening across PSCI catchment area county types: Implications for a self-sampling intervention – Patient Focus Groups

In this study, we will conduct focus groups with women, ages 45-65 years, who are patients in the Penn State Cancer Institute (PSCI) catchment area which includes rural/urban and segregated/not segregated counties in Pennsylvania to learn more about their barriers to cancer screening
Female
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Female residing within the PSCI catchment area
45-65 years of age
Able to speak, read, and communicate well in English
May also participate in the "Comparing barriers to cancer screening across PSCI catchment area county types: Implications for a self-sampling intervention – Patient surveys" study
Exclusion Criteria:
Children
Cognitively impaired
Imprisoned
Complete hysterectomy
History of cervical or colorectal cancer
Cancer, Women's Health
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Hershey, PA
York, PA

Site for Tomosynthesis Mammographic Imaging Screening Trial (TMIST)_EA1151_PSCI 19-080

This study is being done to answer the following question: Can tomosynthesis mammography, three-dimensional x-ray imaging of the breast, lower your chance of developing life-threatening breast cancer through routine screening compared with digital mammography, two-dimensional x-ray imaging of the breast? We are doing this study because we want to find out which of the two usual approaches to breast cancer screening are better in the early detection of life-threatening breast cancers.
Swati Shah at sshah@pennstatehealth.psu.edu
Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT03233191
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Inclusion Criteria:
Women age 45 or older and under age 75 at the time of study entry
Patients must be scheduled for, or have intent to schedule, a screening mammogram.
Patients must be able to tolerate digital breast tomosynthesis and fullfield digital mammographic imaging required by protocol.
Patients must be willing and able to provide a written informed consent.
Exclusion Criteria:
Women of childbearing potential must not be known to be pregnant or lactating.
Patients must not have new symptoms or signs of benign or malignant breast disease
Patients must not have had a screening mammogram within the last 11 months prior to date of randomization.
Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
Patients must not currently have breast enhancements (e.g., implants or injections).
Prevention, Cancer, Women's Health
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Hershey, PA