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Study matches: 34

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
All
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
All
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
All
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
All
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
All
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
All
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.
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

THE PROJECT: EVERYCHILD PROTOCOL: A REGISTRY, ELIGIBILITY SCREENING, BIOLOGY AND OUTCOME STUDY

The next generation of therapy for childhood cancers will be based upon in-depth molecular phenotyping that may facilitate the development of rational risk-adapted and target-based therapies. In order to support current and future molecularly-guided therapeutic trials and the basic science discovery efforts that will lead to more effective therapies, prevention, early detection and a reduction in early and late-onset toxicities, it is critical to implement universal, high-quality collection of annotated biospecimens from children with cancer. This protocol provides for the collection of biospecimens and accompanying demographic, epidemiologic, therapeutic, and outcome data from all children diagnosed with cancer at participating COG institutions, independent of the patient’s enrollment on a therapeutic clinical trial. Through this approach, the correlation of phenotypic and genotypic or other –omic data with the relevant outcomes at the individual, disease, and protocol levels will be ensured. Biospecimen requirements and handling may be disease specific and thus a detailed manual of procedures will provide disease specific information regarding sample collection and processing based on the clinical diagnosis.
Lisa McGregor, MD, PhD at lmcgregor@pennstatehealth.psu.edu or 717-531-6012
Female
All
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Patients with a known or suspected neoplasm that occurs in the pediatric, adolescent or young adult populations are eligible for enrollment
Subjects must be =< 25 years of age at time of original diagnosis
Enrollment can occur at any time after disease presentation
All patients or their parents or legally authorized representatives must sign a written informed consent
Exclusion Criteria:
Age >= 25 years
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NCT02402244
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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) &lt;iframe width="560" height="315" src="https://www.youtube.com/embed/M5GA2Csti9U?rel=0" frameborder="0" allow="autoplay; encrypted-media" allowfullscreen&gt;&lt;/iframe&gt;
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

COG AALL1621 - A Phase 2 Study of Inotuzumab Ozogamicin (NSC# 772518, IND# 133494) in Children and Young Adults with Relapsed or Refractory CD22+ B-Acute Lymphoblastic Leukemia (B-ALL)

This Phase II trial studies how well inotuzumab ozogamicin works in treating younger patients with CD22 positive B acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotoxins, such as inotuzumab ozogamicin, are antibodies linked to a toxic substance and may help find cancer cells that express CD22 and kill them without harming normal cells.
Lisa McGregor, MD at lmcgregor@pennstatehealth.psu.edu or 717-531-6012
All
Younger than 18 years old
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Patients must have B-ALL with ≥ 5% (M2 or M3) bone marrow blasts with or without extramedullary disease
Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by local/institutional flow cytometry of a bone marrow aspirate sample.
Second or greater relapse; Primary refractory disease with at least 2 prior induction attempts
First relapse refractory to at least one prior re-induction attempt
Patients with Ph+ ALL must have had two prior therapy attempts including two different tyrosine kinase inhibitors (TKIs).
Exclusion Criteria:
Patients with any prior history of SOS/VOD irrespective of severity
Patients with isolated CNS, testicular, or other extramedullary site of relapse
Patients who have been previously treated with InO
History of allergic reaction attributed to compounds of similar or biologic composition to InO or other agents in the study.
Patients with active optic nerve and/or retinal involvement that would require urgent radiation therapy concurrent with protocol therapy
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NCT02981628
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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
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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
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NCT03339297
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Hershey, PA

Phase 1b Clinical Trial of Eribulin Mesylate and the PD-L1 Monoclonal Antibody, Avelumab, in Cisplatin Ineligible Metastatic Urothelial Cell Cancer Patients (BTCRC-GU16-051)(PSCI 17-050)

This study is being done to test the safety of combining eribulin mesylate with avelumab. It will also measure the percentage of patients whose tumor shrank after receiving eribulin mesylate in combination with avelumab. Eribulin mesylate: Eribulin mesylate is a chemotherapy that attack cells when they are dividing. Microtubules are part of the cell's structure for dividing and copying itself; like scaffolding on a building. Eribulin blocks microtubules. By blocking the microtubule structures, the cell can’t divide and grow, which causes cell death. Avelumab: Researchers have found that the body’s natural immune system sometimes cannot control cancer growth on its own. Some cancer cells and immune cells make signals that stop the body’s immune system from killing the cancer. In other words, these signals from cancer cells put the brakes on the immune system. Immunotherapy drugs help to take the brakes off the immune system. Avelumab is a drug that blocks a cell signal called PD-L1. This allows the immune system to attack and kill cancer cells.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Stage IV locally advanced node positive or metatatic-M1 positive urothelial cancer of bladder and upper tract
Histologically proven urothelial cancer of bladder with prdominant transitional cell component
Presence of measurable disease per RECIST v1.1 for solid tumors
Patients who are cisplatin ineligible as defined in the protocol
patients must be treatment naive for metastatic disease.
Exclusion Criteria:
Previous treatment with PD1 or PD-L1 inhibitor, including Avelumab
Previous systemic immunotherapy
History of another primary malignancy (except for malignancy treated with curative inten & no known active disease for greater than 5 years, adequately treated non-melanoma skin cancer, lentigo maligna or carcinoma insitu without evidence of disease
Current or prior use of immunosuppressive medication within 28 days before registration
Clinically significant cardiovascular disease
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N/A
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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 in newly diagnosed cancer patients and those with recent progression in their disease 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 six, 1.5 -hour group sessions with her over the span of three 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
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Inclusion Criteria:
Adult >20 years of age
Newly diagnosed with any stage or type of cancer within 3 months OR progression of disease within 3 months of enrollment. Recurrence of cancer within 3 months of enrollment would also be eligible as it will be considered as progression of cancer
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
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N/A
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Hershey, PA

Randomized Feasibility Study of Patient Navigation for Women Identified with Dense Breast Tissue on a Breast Cancer Screening Mammogram - AWARE

This research is being done to find whether a telephone-based navigation improves knowledge, attitude, and behaviors related to dense breast tissue, and if the navigation changes the rate at which the women receive supplemental breast cancer screening, compared to usual care. Approximately 60 women between 40 and 74 years of age with dense breasts will take part in this research study across central Pennsylvania. Participants will be completing surveys by phone up to four times over the 12-week study.
Sol Rodriguez-Colon at srodriguez@psu.edu or 717-531-5190
Female
18 year(s) or older
This study is also accepting healthy volunteers
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Inclusion Criteria:
Female
Age: between 40 and 74 years of age
Had a screening mammogram with the following findings: negative or benign, heterogeneously dense or extremely dense breasts
Exclusion Criteria:
History of breast cancer
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N/A
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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 717-531-0003
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
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
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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

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
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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
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N/A
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Location
Harrisburg, PA
Hershey, PA
State College, 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
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All
This study is NOT accepting healthy volunteers
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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.
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NCT02559778
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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
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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@pennstatehealth.psu.edu or 717-531-5190
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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

Telling Stories, Preventing Cancer: Measuring the Impact of Cancer Survivor Narratives on HPV Vaccination.

We seek to develop a novel video-based HPV vaccine communication intervention using cancer survivor narratives. This project will be conducted in two phases. The first phase includes two activities: 1) interviews with 10 cancer survivors to elicit their stories or experiences with an HPV-related cancer and 2) recording short videos of cancer survivors narrating their own experiences with an HPV-related cancer and recommending parents to get the HPV vaccine for their children to prevent cancer. These videos will be tested in the second phase of the study with a sample of parents of adolescents.
William Calo at wcalo@phs.psu.edu or 717-531-3535
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18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Cancer pateint or survivor who receive care for an HPV-related cancer at the Penn State Cancer Institute
Speak English
18 years or older
Male or female
Exclusion Criteria:
Minors
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N/A
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Hershey, PA
York, PA

A Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC) (EA8143) (PSCI 18-025)

This study is a phase 3 study that will be comparing recurrence-free survival (RFS) between patients with locally advanced renal cell carcinoma randomly assigned to perioperative nivolumab in conjunction with radical or partial nephrectomy with patients randomized to surgery alone.
Kathleen Rizzo at krizzo@pennstatehealth.psu.edu or 717-531-0003
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18 year(s) or older
This study is NOT accepting healthy volunteers
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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
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NCT03055013
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Hershey, 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
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All
This study is NOT accepting healthy volunteers
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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
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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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Hershey, PA