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Study matches: 27

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.


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
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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.
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NCT02639546
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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
Not specified
This study is NOT accepting healthy volunteers
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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.
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NCT02723994
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Hershey, PA

A Single-arm, Prospective Study of Remestemcel-L, Ex-vivo Cultured Adult Human Mesenchymal Stromal Cells, for the Treatment of Pediatric Patients who Have Failed to Respond to Steroid Treatment for Acute GVHD

A study of the safety and effectiveness of remestemcel-L in pediatric subjects with acute Graft versus Host Disease (aGVHD) following transplant (HSCT) that has failed to respond to steroid treatment.
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
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Inclusion Criteria:
A diagnosis of acute GVHD.
2 months of age and older to under 18 years of age.
Patient has failed to respond to steroid treatment.
Exclusion Criteria:
Has had any second line therapy to treat aGVHD.
Severe hepatic veno-occlusive disease (VOD).
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NCT02336230
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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
Not specified
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Age 6 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
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NCT02932280
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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 x 284676
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
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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
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N/A
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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
Not specified
This study is NOT accepting healthy volunteers
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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.
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N/A
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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.
Hannah Guthrie at hdpar@psu.edu or 8148630132
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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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
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N/A
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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
Not specified
This study is NOT accepting healthy volunteers
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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.
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NCT00601003
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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
Not specified
This study is NOT accepting healthy volunteers
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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.
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NCT02679144
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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
Not specified
This study is NOT accepting healthy volunteers
Hide eligibility criteria
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.
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NCT02512926
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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.
nurseamie@phs.psu.edu
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
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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
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N/A
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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
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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.
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NCT02369653
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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
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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.
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NCT02851407
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Hershey, PA

A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of MitoGel™ 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
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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.
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NCT02793128
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Hershey, PA

PHASE 1B, MULTICENTER, OPEN-LABEL STUDY OF MARIZOMIB COMBINED WITH TEMOZOLOMIDE AND RADIOTHERAPY IN PATIENTS WITH NEWLY DIAGNOSED WHO GRADE IV MALIGNANT GLIOMA

Gliomas account for ~80% of primary malignant tumors in the Central Nervous System (CNS), with WHO Grade IV malignant glioma (G4 MG; including glioblastoma and gliosarcoma) constituting the majority of gliomas, and are essentially incurable. Currently only surgical resection and radiotherapy (RT) with concomitant and adjuvant temozolomide (TMZ) are standard-of-care treatment strategies for newly diagnosed G4 MG. However, resistance to chemotherapy and RT results in a high recurrence rate, with median survival of ~15-16 months. Since no survival advantage has been demonstrated for the addition of bevacizumab (BEV) to TMZ and RT (Chinot 2014) in newly diagnosed G4 MG, alternative promising investigational agents need to be tested.
Cynthia Campbell-Baird at cbaird@pennstatehealth.psu.edu or 717-531-0003 ext 5777
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Histologically confirmed newly diagnosed G4 MG
performance status > 70%
no investigational agent up to 4 weeks prior to study drug
Adequate Blood, kidney, and liver function
For Adjuvant Treatment: No prior treatment with BTZ, CFZ, or IXZ.
Exclusion Criteria:
Co-medication or concomitant therapy that may interfere with study results, e.g., immuno-suppressive agents other than corticosteroids.
History of thrombotic or hemorrhagic stroke or myocardial infarction within 6 months.
Chemotherapy or other anti-tumor treatment for brain tumor
Uncontrolled intercurrent illnes
Known other previous/current malignancy requiring treatment within ≤ 3 years
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NCT02903069
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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.
Jessica Wright at jwright3@pennstatehealth.psu.edu or 284713
All
18 year(s) or older
This study is also accepting healthy volunteers
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Inclusion Criteria:
Scheduled for colonoscopy in the next 4 months
60 years of age and older
able to tolerate removal of 5 tubes (3.5 tablespoons) of blood
willing to provide blood, urine and stool samples
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
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NCT01511653
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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.
Stephanie Gorrell at sgorrell@pennstatehealth.psu.edu or 717-531-0003, x286789
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
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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
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NCT02438358
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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
Not specified
This study is NOT accepting healthy volunteers
Hide eligibility criteria
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.
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NCT02559778
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Hershey, PA

A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification

Phase 2b: To determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide plus adjuvant temozolomide prolongs Progression Free Survival (PFS) among subjects with newly diagnosed GBM harboring EGFR amplification. Phase 3: To determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide plus adjuvant temozolomide prolongs Overall Survival (OS) among subjects with newly diagnosed GBM harboring EGFR amplification.
Nikita Shah at nshah3@pennstatehealth.psu.edu or 717-531-0003 ext 282645
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
EGFR amplification in tumor tissue confirmed by central assessment.
Histologically confirmed GBM
Ability to receive local radiation
Peformance Status above 70%
Exclusion Criteria:
Subject has multifocal GBM.
Any prior therapy for glioblastoma
Subject has recurrent GBM
Prior invasive malignancy
Prior radiotherapy to the head or neck
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NCT02573324
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Hershey, PA

A Phase Ib/II Study of Anti-PD-1 Antibody Pembrolizumab and Imprime PGG for Patients With Metastatic Non-small Cell Lung Cancer After Progression on First-Line Chemotherapy: Big Ten Cancer Research Consortium BTCRC-LUN15-017 PSCI#17-020

Your immune system sends out special cells called T cells to fight infections and diseases throughout your body. Some cancer cells can hide from T cells by taking control of a pathway called PD-1. This lets the cancer cells avoid an attack from T cells. Pembrolizumab (Keytruda®, MK-3475) is an immunotherapy that blocks the PD-1 pathway. By blocking PD-1, it restores the body’s immune response against cancer cells and allows the immune system to recognize and kill cancer cells. Imprime PGG is a new immunotherapy that also uses the immune system to kill cancer cells. Innate immune cells (neutrophils, monocytes and macrophages) normally kill things like bacteria or viruses. Receptors on these innate immune cells recognize Imprime PGG. This causes a chain of immune responses which activate the immune system to attack cancer cells. This study is being done to estimate the length of time Imprime PGG and pembrolizumab will control your cancer. Researchers hope when they combine pembrolizumab and Imprime PGG, the two drugs will have more benefits than giving either drug on its own. Pembrolizumab is approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced skin cancer, advanced non-small cell lung cancer, and advanced head and neck cancer. The FDA has not approved Imprime PGG to treat any disease. Therefore, combining pembrolizumab and Imprime PGG should be considered investigational. “Investigational” means that the FDA has not approved this combination of drugs for your type of cancer.
Rebecca Hale at rhale1@pennstatehealth.psu.edu or 717-531-1003
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Subjects with histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
Subjects without EGFR activating mutation nor ALK translocation.
Subjects who progressed after first-line platinum-based chemotherapy and who are candidates for second-line therapy.
Subjects with stage IV non-small cell lung cancer (NSCLC) as defined by American Joint Committee on Cancer (AJCC).
Measurable disease according to RECIST v1.1 (Section 8) obtained by imaging within 28 days prior to study registration.
Exclusion Criteria:
Surgery within 4 weeks prior to study registration except for minor procedures.
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis.
Previously received an organ or allogeneic progenitor/stem cell transplant.
Received a live vaccine within 30 days prior to the first dose of trial treatment. Examples of live vaccines include, but are not limited to: measles, mumps, rubella, chicken pox, yellow fever, rabies, BCG, and typhoid (oral) vaccine.
History of blood clots, pulmonary embolism, or deep vein thrombosis unless on adequate anticoagulant therapy as determined by the treating investigator (subject must be on stable dose for 2 weeks).
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NCT03003468
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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@phs.psu.edu or 814-476-0171
All
18 year(s) or older
This study is also accepting healthy volunteers
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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
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N/A
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Hershey, PA
State College, PA

An Early Phase, Multicenter, Open-Label Study of the Safety and Pharmacokinetics of Atezolizumab Antibody (Mpdl3280a) in Pediatric and Young Adult Patients with Previously Treated Solid Tumors

A study to determine if atezolizumab is safe and effective for patients with solid tumors that have not responded to previous treatment.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
Not specified
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
Confirmed solid tumor of varying types which has not responded to previous treatment.
Age at beginning of study is less than 30 years.
Weighs at least 3 kilograms (6.6 pounds).
Disease that is measurable based on accepted standards.
Tumor tissue from past surgery is available or willingness to have a biopsy prior to enrollment.
Exclusion Criteria:
Known brain tumor.
Patients with lymphoma, or other related diseases.
Treatment with high-dose chemotherapy and hematopoietic stem-cell rescue within a certain period of starting the study drug.
Prior stem-cell transplantation or prior solid-organ transplant.
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NCT02541604
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Hershey, PA

9A Multicenter Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor in Patients with Newly Diagnosed or Recurrent Malignant Gliomas: A Safety, Histopathology, and Correlative Biomarker Study

In support of the US marketing application for 5-ALA, this single arm trial is being conducted to establish the efficacy and safety of Gliolan (5-ALA) in patients with newly diagnosed or recurrent malignant gliomas. The hypothesis of the study is Gliolan (5-ALA), as an adjunct to tumor resection, is safe and that real-time tissue fluorescence correlates with malignant histopathology. The primary objective in this single arm study is to define the positive predictive value (PPV) of Gliolan-induced PPIX fluorescence for malignant tumor at the time of initial resection and first use of FGS by taking a biopsy of tissue presenting with red fluorescence when observed during the course of resection of new or recurrent malignant gliomas.
Brad Zacharia at bzacharia@hmc.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Age 18-80
MRI documenting primary brain tumor with presumed malignant glioma
Intended surgical resection
Karnofsky >= 60%
Exclusion Criteria:
Radiographic tumors of, or involving, nonresectable midline, basal ganglia or brainstem
Personal or family history of porphyria
Women who are pregnant
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NCT02632370
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Location
Hershey, PA

A Phase II Study of Pazopanib (GW786034, NSC# 737754) in Children, Adolescents and Young Adults with Refractory Solid Tumors

A study of the safety and efficacy of pazopanib for pediatric patients with solid tumors not responding to treatment.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 717-531-3097
All
Not specified
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Must be at least 1 year old and less than or equal to 18 years old when beginning the study.
A confirmed solid tumor of varying types.
Disease must have returned or is not responding to therapy.
Disease must be measurable by standard tests.
Must pass organ function and other tests.
Exclusion Criteria:
Female patients who are pregnant or breast-feeding are not eligible.
Patients who are currently receiving another study drug are not eligible.
Patients who are currently receiving other anti-cancer agents or radiation therapy are not eligible.
Patients who are unable to swallow tablets or liquid are not eligible.
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NCT01956669
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Hershey, PA

A Phase I/II, Single Arm, Non-randomized Study of Ribociclib (LEE011), a CDK 4/6 Inhibitor, in Combination with Bicalutamide, an Androgen Receptor (AR) Inhibitor, in Advanced AR+ Triple-negative Breast Cancer: Big Ten Cancer Research Consortium BTCRC-BRE15-024 (BRE15-024) (17-021)

Subjects to be enrolled in this study do not have the three common breast cancer receptors (estrogen, progesterone, HER-2), researchers are looking for other receptors to block. Androgen receptor (AR) is expressed in some triple negative breast cancer tumors. Androgen receptor blockers are normally used to treat prostate cancer but researchers have some evidence they are also useful in breast cancer. Researchers will use an AR blocker called bicalutamide in this trial. Cancer cells have the ability to grow and divide without stopping. Ribociclib is an enzyme inhibitor that acts as a “brake” to interrupt and slow or stop the growth of cancer cells. Ribociclib may also help prevent resistance to the androgen receptor therapy. Researchers think that combining ribociclib and bicalutamide will have more benefits than giving either drug on its own. This study is being done to find the safe dose of ribociclib combined with bicalutamide and to find out if the combination has any effect on triple negative breast cancer.
Lea May at lmay1@pennstatehealth.psu.edu or (717) 531-0003, ext. 285550
Female
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Metastatic or unresectable AR+ triple-negative breast cancer (TNBC); AR positivity assessed centrally and defined as IHC staining of >0% of tumor nuclei.
ECOG Performance Status of 0 or 1 within 28 days prior to registration.
Measurable disease according to RECIST 1.1 within 28 days prior to registration.
No active central nervous system (CNS) metastatic disease.
Prior cancer treatment must be completed at least 14 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen
Exclusion Criteria:
Prior therapy with AR antagonists including but not limited to bicalutamide, enzalutamide, abiraterone and orteronel.
Prior therapy with any CDK 4/6 inhibitors.
Active infection requiring systemic therapy.
Known additional malignancy that is active and/or progressive requiring treatment
Treatment with any investigational drug within 14 days prior to registration or within 5 half-lives of the investigational product, whichever is longer.
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NCT03090165
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Hershey, PA

IMpact of PRehabilitation in Oncology Via Exercise – Breast cancer

It is well known that breast cancer patients suffer from many cancer- and treatment-related side effects that all worsen overall quality of life. Besides dealing with existing treatment-related side-effects, there is the idea of prehabilitation a process on the cancer continuum of care that occurs between the time of cancer diagnosis and the beginning of acute treatment. IMPROVE-B will evaluate an exercise prehabilitation approach with regard to safety, feasibility, acceptability and effectivity in breast cancer patients (n=30) prior surgery.
Joachim Wiskemann at jwiskema@phs.psu.edu or 717-531-0003 ext. 289736
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Scheduled for breast cancer surgery
Not metastatic (stage <4)
more than 2 weeks till surgery
Exclusion Criteria:
Receiving neoadjuvant chemotherapy or radiotherapy
Pregnant
• Engaging in systematic intense exercise training (at least 1h twice per week)
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N/A
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Hershey, PA

Risk-based, response-adapted, Phase II open-label trial of nivolumab + brentuximab vedotin (N + Bv) for children, adolescents, and young adults with relapsed/refractory (R/R) CD30 + classic Hodgkin lymphoma (cHL) after failure of first-line therapy, followed by brentuximab + bendamustine (Bv + B) for participants with a suboptimal response. CheckMate 744: CHECKpoint pathway and nivolumab clinical Trial Evaluation

This is is a Phase 2, open-label study of nivolumab and brentuximab for children and young adults with relapsed/refractory classic Hodgkin lymphoma.
Suzanne Treadway, MS, RN, CCRP at streadway@pennstatehealth.psu.edu or 7175313097
All
Not specified
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Must be 5-30 Years of Age
A confirmed diagnosis of Classic Hodgkin Disease
Failed or did not respond to initial treatment
Exclusion Criteria:
A previous allogeneic stem cell transplant
Received certain antibody therapies in the past
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NCT02927769
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Location
Hershey, PA