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Suggestions within category "Cancer"


39 Study Matches

A Phase I/II, Multicenter, Open-Label, Dose Escalation Study of the Safety and Pharmacokinetics of Cobimetinib in Pediatric And Young Adult Patients with Previously Treated Solid Tumors

A study of the safety and effectiveness of cobimetinib in patients with previously treated solid tumors.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT02639546
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Inclusion Criteria:
A solid tumor that has not responded to previous treatment.
Age must be 6 months or older to younger than 18 years of age.
Disease must be measurable by accepted tests.
Availability of tumor tissue at study enrollment is mandatory.
Exclusion Criteria:
Prior treatment with cobimetinib or other similar drug.
Treatment with high-dose chemotherapy and stem-cell rescue within 3 months prior to the study.
Children's Health, Cancer
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Hershey, PA

A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway–Mutant Acute Lymphoblastic Leukemia

A study of the safety and efficacy of ruxolitinib with routine chemotherapy for children with leukemia with specific genetic changes.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT02723994
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Inclusion Criteria:
A diagnosis of leukemia, specifically de novo high B-ALL with eligible genetic changes.
Age must be greater than 1 year old and less than or equal to 21 years old at leukemia diagnosis.
Have completed an acceptable induction therapy either on study or by hospital standard of care.
Exclusion Criteria:
Had any other chemotherapy before induction therapy, with exceptions.
Down Syndrome.
Children's Health, Cancer
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Hershey, PA

A Phase I/II Study of Neratinib in Pediatric Patients with Relapsed/ Refractory Solid Tumors or Hematologic Malignancies

Neratininb for childhood cancer that has returned or is not responding to previous therapy
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT02932280
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Inclusion Criteria:
Age 3 to 21 Inclusive
Cancer that has returned or is not responding to previous therapy
Has failed at least one prior therapy
Exclusion Criteria:
Certain prior therapies
Children's Health, Cancer
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Hershey, PA

Women In Steady Exercise Research - Neoadjuvant Exercise Trial

The primary purpose of this pilot study is to determine whether breast cancer patients whom elect to undergo cardiotoxic neoadjuvant chemotherapy can be enrolled and retained in a 6 month at home aerobic exercise training study. Using a randomized controlled trial approach, we will examine the safety and efficacy of a well monitored moderate-to-high intensity aerobic training program completed at home in breast cancer patients receiving neoadjuvant chemotherapy. In addition to assessing safety and efficacy of the program, we will assess intervention effects on cardiopulmonary fitness, cardiac function, and tumor response.
Kathleen Sturgeon at kms99@psu.edu or 717-531-0003, ext=284676
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Stage 1-3 breast cancer
Scheduled to start neoadjuvant chemotherapy
Sedentary
No heart disease
Exclusion Criteria:
Stage 4 breast cancer
Heart disease
Non-English speaking
Cancer
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Greater Philadelphia Area, PA
Harrisburg, PA
Hershey, PA

Molecular-guided therapy for the treatment of patients with relapsed and refractory childhood cancers

Molecular-guided therapy for childhood cancer that has returned or is not responding to previous therapy.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 771-531-3097
All
All
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
A diagnosis of pediatric cancer of varying types for which there is no known cure or disease that is not responding to treatment.
Must be over one year of age at enrollment.
Must be less than or equal to 21 years at initial diagnosis.
Must have measurable disease by accepted standards.
Tumor must be accessible for biopsy.
Exclusion Criteria:
Has received chemotherapy within the last 7 days of biopsy.
Has received any radiotherapy to the primary sample site within the last 14 days.
Currently taking any other study drug.
Children's Health, Cancer
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Hershey, PA

Feasibility and acceptability of mind-body strategies to increase physical activity and reduce health disparities in rural breast cancer survivors

The purpose of this study is to explore feasibility and acceptability of mind-body strategies to increase physical activity and reduce health disparities in rural cancer survivors and inform the cultural-adaptation of a physical activity intervention for rural breast cancer survivors.
Scherezade Mama at hdpar@psu.edu or 814-863-0132
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 of age
Received a cancer diagnosis previously
Lives in central Pennsylvania
Exclusion Criteria:
Below the age of 18
No history of cancer
Lives outside of the Penn State Cancer Institute's 28-county catchment area
Prevention, Mental & Behavioral Health, Cancer
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A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma and Medulloblastoma

A study if the safety and effectiveness of nifurtimox in children with neuroblastoma or medulloblastoma, that has returned or is not responding to treatment.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT00601003
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Inclusion Criteria:
Ages 0-21 years at the time of diagnosis.
Diagnosis of neuroblastoma or medulloblastoma.
Disease has not responded to previous treatment.
Disease is measurable bu accepted tests.
Exclusion Criteria:
Patients who weigh less than 3.5 kg (7.7 lbs).
Currently receiving another study drug.
Currently receiving other anticancer agents.
Children's Health, Cancer
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Hershey, PA

NMTT- Neuroblastoma Maintenance Therapy Trial Using Difluoromethylornithine (DFMO)

A study of DFMO for patients with neuroblastoma in remission.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT02679144
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Inclusion Criteria:
A confirmed diagnosis of neuroblastoma.
Must be in complete remission (CR).
Tests and scans will be required to confirm remission.
Exclusion Criteria:
Patients below the defined minimum of height and weight.
Patients who are currently receiving another study drug may not participate.
Patients who are currently receiving other anticancer agents may not participate.
Children's Health, Cancer
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Hershey, PA

Phase I Study of Carfilzomib in combination with Cyclophosphamide and Etoposide for Children with Relapsed or Refractory Solid Tumors and Leukemias

A study of the safety of carfilzomib for children with solid tumors and leukemias that returned or did not respond to previous treatment.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT02512926
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Inclusion Criteria:
Diagnosis of relapsed or refractory leukemia or solid timor.
Age 6 months to less than 30 years at enrollment.
Must be fully recovered from effects of previous treatment.
Life expectancy greater than or equal to 3 months.
Exclusion Criteria:
Prior treatment with carfilzomib.
Known allergy to Captisol®.
Down syndrome.
Children's Health, Cancer
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Hershey, PA

Nurse AMIE: A tablet based supportive care platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)

We propose to build and test a software program called Nurse AMIE (Addressing Metastatic Individuals Everyday) to be provided to Stage IV breast cancer patients on an electronic tablet. This program will be tested in 50 Stage IV breast cancer patients who live within the Penn State Cancer Institute’s 28 county catchment area. Goals of the Nurse AMIE are to regularly assess mental-health, physical health, and other symptom related needs among Stage IV breast cancer patients and to provide appropriate help via videos, weekly calls (face to face, tablet to tablet) with a patient guide at Penn State, and appropriate referrals to phone or in person visits (as needed). The proposed Nurse AMIE software program will allow for the plan of resources (videos, audio files, exercises) to help with many of the common symptoms and challenges experienced by the patients. This is an identified need on the part of both the patients and their medical care teams. Finally, it will also allow patient guides to check in with patients, review responses to surveys, decide whether new or different documents or videos are needed, and connecting the patient to palliative care and other services if additional care is found to be needed.
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
metastatic breast cancer
ECOG<3
English speaking
sufficient vision/hearing or family support
Exclusion Criteria:
Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction).
Patients who are receiving any other behavioral intervention
Cancer
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Hershey, PA

A Phase III Randomized, Open Label, Multi-center Study of the Safety and Efficacy of Apixaban for Thromboembolism Prevention versus No Systemic Anticoagulant Prophylaxis during Induction Chemotherapy in Children with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoma (T or B cell) Treated with Pegylated Asparaginase

A study to confirm and expand information on safety and effectiveness of apixaban to prevent blood clots as compared to no prevention treatment in children with newly diagnosed leukemia and lymphoma. This is a randomized study so patients will be selected by chance to be in either the group that receives apixaban or the group that does not receive apixaban.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT02369653
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Inclusion Criteria:
New diagnosis of leukemia (de novo ALL) or lymphoma (T or B cell).
An acceptable planned induction chemotherapy.
One year of age and older to less than 18 years of age.
Able to take oral medication or have it given through a tube.
Exclusion Criteria:
Had a blood clot in the past 3 months.
Known inherited bleeding disorder.
Children's Health, Cancer
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Hershey, PA

A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant

A study to confirm and expand information on safety and effectiveness of defibrotide compared to best standard care to prevent veno-occlusive disease of the liver in adult and pediatric transplant patients. This is a randomized study so patients will be selected by chance to be in either the group that receives defibrotide or the group that does not receive defibrotide.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT02851407
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Inclusion Criteria:
Must be older than 1 month of age.
Scheduled for a stem cell transplant and be at high risk of veno-occlusive disease.
Be at high risk of veno-occlusive disease.
Exclusion Criteria:
Unstable blood pressure.
Episodes of bleeding.
Blood Disorders, Children's Health, Cancer
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Hershey, PA

A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel™(UGN-101) on Ablation of Urothelial Carcinoma Lesions in the Upper Urinary Tract

This is a clinical trial, designed to determine safety &amp; effectiveness of and patient reaction to the use of MitoGel™ in the upper urinary system of patients with non-invasive low-grade (LG), urotheilal cancer (UTUC)
Kathleen Lehman at klehman3@pennstatehealth.psu.edu or 717-531-5930
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02793128
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Inclusion Criteria:
At least one (1) measurable and biopsy-confirmed papillary Low Grade tumor, evaluated visually, ≤ 15 mm.
ECOG (Eastern Cooperative Oncology Group) performance status <3 (with Karnofsky >40).
Life expectancy greater than 24 months.
Adequate organ and bone marrow function as determined by routine laboratory tests
New or recurrent patients with LG, non-invasive UTUC in the pyelocalyceal system.
Exclusion Criteria:
Patient received BCG treatment for UC during the 6 months prior to Visit 1.
The patient has untreated concurrent urothelial cancer in other locations other than the target area (unless treated during screening).
Carcinoma in situ (CIS) in the past in the urinary tract.
Patient has a history of invasive urothelial carcinoma in the urinary tract during the past 5 (Five) years.
Patient is actively being treated or intends to be treated with systemic chemotherapy during the duration of the trial.
Kidney & Urinary System, Cancer
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Hershey, PA

A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant

A study of defibrotide to prevent acute GVHD. Subjects will be randomized to receive either defibrotide with routine prevention or to receive routine prevention alone.
Suzanne Treadway at streadway@pennstatehealth.psu.edu or 717-531-3097
All
All
This study is NOT accepting healthy volunteers
NCT03339297
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Inclusion Criteria:
Be ≥1 year and <75 years of age
A diagnosis of acute leukemia in remission
Exclusion Criteria:
Prior transplant
Acute bleeding
Cancer
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Hershey, PA

Effect of Group Led Creative Writing on Mood in Cancer Patients

The primary purpose of this study is to determine whether creative writing for cancer patients will have a positive impact on their mental health. Using a randomized controlled trial approach; we will be utilizing emotion thermometers to evaluate response on a number of domains such as anxiety, depression, despair and anger along with a series of survey questions to monitor changes in depressive and anxiety symptoms. Open-ended survey questions will be used to capture how this intervention impacts patient experience of their illness. Melissa Greene’s “Write from the Heart” program focuses more on creative writing rather than cancer focused topics. Patients in the intervention arm will have a minimum of four, 1.5 -hour group sessions with her over the span of two months. Patients in control arm will be provided a book (Writing Down Bones by Natalie Goldberg) about creative writing and will be asked to do activities for 1.5hrs every 2 weeks.
Darya Nesterova at dnesterova@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
Adult >20 years of age
Has cancer diagnosis
Ability to understand English language and ability to write without any functional difficulty
ECOG performance status 0-3
Exclusion Criteria:
Inability to give informed consent
Severe psychiatry illness (e.g., uncontrolled depression, schizophrenia or psychosis
Severe cognitive impairment
Pregnant females
Inability to write or understand English
Cancer
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Hershey, PA

A Multicenter, Randomized, Double-blind, Vehicle-controlled, Phase 3 Efficacy and Safety Study of Patidegib Topical Gel, 2%, for the Reduction of Disease Burden of Persistently Developing Basal Cell Carcinomas (BCCs) in Subjects with Basal Cell Nevus Syndrome

Basal Cell Nevus Syndrome: Phase 3 Double-Blind, 12 month study. Topical Gel, Males/Females 18 years and older with Basal Cell Nevus (Gorlin) syndrome. Basal Cell Carcinomas (BCC) are slow growing tumors of the skin. They can be sporadic or inherited. Basal Cell nevus (Gorlin) syndrome is a rare autosomal dominant heritable disease. The purpose of the study is to assess the number of new surgical BCCs and to evaluate the safety of the drug and how the drug is tolerated in patients.
Amy Longenecker at alongenecker@pennstatehealth.psu.edu or 717-531-5136
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03703310
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Inclusion Criteria:
Must have had at least 10 (at least 3 on face) Basal Cell Carcinomas present within the past 24 months
Must be willing to have blood collected
Willing to follow all study instructions
Exclusion Criteria:
Certain treatments are not allowed; coordinator will discuss specific treatments
unable or unwilling to return to the study site for all study visits and tests.
Certain invasive cancers are not allowed to participate; coordinator will discuss
Skin Conditions, 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 colorectal cancer survivors preparing for follow-up appointments: An ecological momentary assessment study

Have you been diagnosed with colorectal cancer? Have you completed cancer treatment(s)? Are you scheduled or planning to schedule a colonoscopy? We are trying to understand how follow-up appointments impact the everyday health and wellbeing of colorectal cancer survivors. We are seeking men and women who have completed treatments for stages 1 through 3 colorectal cancers, and have a scheduled colonoscopy or plan to schedule a colonoscopy in the next 90 days. In this study, you will be asked to: - Attend two short (less than 60 minute) visits at the Penn State University Park Campus (Clinical Research Center) - Carry a pre-programmed cellphone to answer six quick surveys per day in the week before your scheduled colonoscopy - Receive up to $30 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 (45-70)
Colorectal cancer diagnosis stage 1 through 3
Completed primary cancer treatment at least 3 months prior to participating
Have a scheduled colonoscopy or plan to schedule in the next 90 days
Fluent in English
Exclusion Criteria:
No colorectal cancer diagnosis, or diagnosis of Stage 0 or 4 colorectal cancer
Under the age of 45 or over the age of 70
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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Harrisburg, PA
Hershey, PA
State College, 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

CO-338-085: A Phase 2, Open-Label Study of Rucaparib in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

This research is being done to find out more about the drug called rucaparib (also known as CO-338) and Rubraca. Rucaparib is being developed by Clovis Oncology, Inc. (“Sponsor”), a biopharmaceutical company with headquarters in the United States (US). Rucaparib is approved (trade name: Rubraca) in the US as treatment for patients with advanced ovarian cancer who have been treated with two or more chemotherapies and who have a certain type of abnormal BRCA gene.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03397394
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Inclusion Criteria:
Be ≥ 18 years of age at the time the Informed Consent Form (ICF) is signed.
Received 1 or 2 prior standard of care treatment regimens
Mandatory tumor tissue must be collected
Have measurable disease
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 14 days prior to first dose of rucaparib.
Exclusion Criteria:
Prior treatment with a PARP inhibitor.
Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib.
Non-study related minor surgical procedure ≤ 5 days, or major surgical procedure ≤ 21 days, prior to first dose of rucaparib; in all cases, the patient must be sufficiently recovered and stable before treatment administration.
Pregnant or breast feeding.
Refusal to use highly effective method of contraception or to practice true abstinence during treatment and for 6 months after the last dose of rucaparib
Cancer
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Location
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

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

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 21 years or older. Because no dosing or adverse event data are currently available on the use of LUM015 in subjects <21 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