Search Results Within Category "Cancer"
PSCI 21-191: CG-745-2-08
The purpose of this voluntary research study is to learn more about an investigational drug (also known as the “study drug”) called ivaltinostat as a possible treatment for metastatic pancreatic adenocarcinoma.
Participants will be required to attend all study visits, receive drug treatment, have blood drawn, imaging assessments and tumor biopsy if needed
Age: ≥18 years
Histologically or cytologically confirmed pancreatic adenocarcinoma
Patients with or without radiographically measurable disease per RECIST v1.1 are eligible to participate.
Patients with metastatic disease are eligible.
Cytotoxic chemotherapy or non-hormonal targeted therapy within 21 days of Cycle 1 Day 1 is not permitted
Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to randomization.
Any previous treatment with a histone deacetylase (HDAC) inhibitor, including ivaltinostat.
Other primary cancers.
Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (PSCI# 21-115) (EAA173).
The purpose of this study is to determine whether patients with high-risk smoldering multiple myeloma when treated with daratumumab in addition to lenalidomide and dexamethasone live longer when compared to patients with high-risk smoldering multiple myeloma patients treated with lenalidomide and dexamethasone. We would also like to know whether the period of time in which patients are free of multiple myeloma symptoms differs between the two treatment groups.Daratumumab is already approved by the FDA for use in combination with lenalidomide and dexamethasone in people who have received at least one prior medicine to treat multiple myeloma. It is not, however, approved for treatment of smoldering multiple myeloma, either alone or when combined with the treatment regimen of lenalidomide and dexamethasone, and therefore is considered experimental. Lenalidomide and dexamethasone are approved for treatment of multiple myeloma (symptomatic) but not for the treatment of smoldering multiple myeloma and therefore is also considered an experimental treatment.
We are asking you to take part in a research study because you have high-risk smoldering multiple myeloma. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer.
Patient must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months.
A bone marrow aspirate and/or biopsy is required to be performed within 42 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
Patient must have adequate organ and marrow function.
Patient must agree to register into the mandatory REMS program and be willing and able to comply with the requirements of REMS.
Concurrent use of erythropoietin is not allowed while on study therapy.
Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted.
Patients with monoclonal gammopathy of undetermined significance are not eligible.
Patient must not have Grade 2 or higher peripheral neuropathy per CTCAE.
EA9161: A Randomized Phase III Study of the addition ofVenetoclax to Ibrutinib and Obinutuzumab versus Ibrutiniband Obinutuzumab in Untreated Younger Patients withChronic Lymphocytic Leukemia (CLL)
The is a drug study to compare the progression freesurvival of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax (IOV) to Ibrutinib-Obinutuzumab (IO) in untreated CLL patients younger than 70 years of age.
pt will either get ibrutinib and obinutuzumab, plus venetoclax for up to 19 months or will get ibrutinib and obinutuzumab until doctor decides disease is getting worse or the side effects become too severe. After 19 cycles completed, doctor will follow condition every 90 days until progression and watch for side effects. They will check pt every 3 months for 2 years. After that, they will check pt every 6 months for 3 years. After that, they will check pt every 12 months for 5 years
Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy
Age ≥ 18 years and < 70.
ECOG performance status between 0-2.
Life expectancy of ≥ 12 months.
No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment.
No current use of corticosteroids.
No previous autoimmune complications
No other active primary malignancy
PSCI 24-015 S2212 SHORTER ANTHRACYCLINE-FREE CHEMO IMMUNOTHERAPY ADAPTED TO PATHOLOGICAL RESPONSE IN EARLY TRIPLE NEGATIVE BREAST CANCER (SCARLET), ARANDOMIZED PHASE III STUDY
To see if participants with early stage triple negative breast cancer randomized to receive anthracycline-free, taxane-platinum neoadjuvant chemotherapy with pembrolizumab have a better breast cancer event-free survival (BC-EFS)compared to participants randomized to taxane-platinum-anthracycline neoadjuvant chemotherapy with pembrolizumab.
keep all study appointmentsreport to your study team any side effects or any changes in medication
Participants must have breast and axillary imaging with mammogram and/or ultrasound and/or MRI within 49 days prior to randomization.
Participants must not have metastatic disease
Participants must not have received prior systemic therapy or radiation therapy
Participants must be ≥ 18 years old.
Participants must not have a prior or concurrent malignancy
Participants must not have received a live vaccine within 30 days prior to randomization.
Participants must not have active autoimmune disease
Participants must not have severe or active infections
A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)
Participants in this study will receive a drug called ribociclib with the endocrine therapy of your physician’s choice. Ribociclib is taken as a pill. Endocrine therapy is taken as a pill or given as a shot. You will have tests, exams and procedures that are part of your regular care and for study purposes. Also, as part of routine care, you will be checked every 4 to 12 weeks to make sure your cancer hasn’t come back. You will receive ribociclib combined with endocrine therapy for up to 3 years. After that you will continue endocrine therapy alone for another 2 years (5 years total) as part of your regular care.
Participants will be required to: - receive ribociclib along with standard endocrine therapy drugs - have blood drawn - imaging scans (CT, PET-CT, bone scans, mammograms, MRI) - keep a medication diary - optional biopsy - ECG-a test that looks at the way your heart beats - ECHO-a test that looks at the way your heart pumps
Male or female age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
If patient is receiving tamoxifen or toremifene, a washout period of 28 days prior to registration is required.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.
Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.
Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
Pregnant or breastfeeding or planning to become pregnant during the trial
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety
A Phase Ib/11 Study of Propranolol with fixed-dose Pembrolizumab in Patients with Unresectable Stage III and Stage IV Melanoma
This research is being done to find out the safety of propranolol and, identify the maximum tolerated dose of propranolol that can be administered in combination with pembrolizumab in patients with unresectable stage III and stage IV melanoma. This study will evaluate this novel combination of pembrolizumab and propranolol to see what effect it may have on how your cancer responds to the treatment combination.
Phase II*propranolol twice a day.*pembrolizumab by an infusion every 3 weeks.*May receive treatment with pembrolizumab and propranolol for up to24 months from the time they began treatment with the combination.Procedures to be done:. A medical history A physical exam ECOG Performance Status Perceived Stress Scale questionnaire An assessment of tumor by scan. Scans may include:o Computed tomography (CT), with or without contrast. o Magnetic resonance imaging (MRI) or head CT with IV contrast Blood tests:o Approximately 2 tablespoons for routine testing, such as a complete blood count and acomprehensive metabolic panel Pregnancy test Urinalysis Electrocardiogram A sample of tumor from a previous biopsy or sample taken Phase 1 portion of the study, these evaluations/tests will also occur on Day 8 of Cycle 1 Review concomitant medications. Physical Exams ECOG Performance Status Perceived Stress Scale questionnaire Blood tests:o Every 3 weekso At 3 weeks and 6 months or discontinuation of treatment (whichever comes sooner) and atdisease progressiono Every 3 weeks: Approximately 1 tablespoon for tests that monitor your blood sugar levelsand thyroid functiono Every week for the first 6 weeks then every cycle for another 6 weeks Assessment of cancer by CT or MRI. These assessments will be performed every 12 weeks(± 14 days). The first assessment will be after completing Cycle 4. If their cancer is found to be improving,repeat the CT and MRI scans in about 12 weeks. EKG: Once treatment begins, this will be done every cycle prior to receiving pembrolizumab for the first 5 cycles. Adverse events Tumor Biopsy: A tumor biopsy (only in phase II) will be obtained at the 12 weeks after initiation oftreatment.Tumor biopsy will be optional for phase II patients..Safety Follow-Up:After all study treatment has stopped, end of treatmentvisit, which will be approximately 30 days after their last dose of study drug or before starting a newtreatment Medical History: Concomitant medications complete physical examination ECOG Performance Status Perceived Stress Scale assessment Adverse events Survival status Blood tests:o Follow- Up Phase3 Month and 6 Month Follow- up After Treatment blood collected.The following assessments will be performed at 3 months and 6 months after the safety follow-up visit.Review concomitant medications Physical examination ECOG Performance Status Adverse events Survival Status Blood tests: CT of chest, abdomen and pelvis, or other areas as needed Long Term Survival Follow- Up:After your 3 month and 6 month follow up visits or if they progress, will be contacted every 6 months (±30 days)
Participants must be newly diagnosed, treatment-naive with histologically confirmed stage IIIC unresectable melanoma or stage IV melanoma.
Have measurable disease per RECIST v1.1
Have an ECOG performance status 0-1
Participants with chronic autoimmune diseases
Other invasive cancers diagnosed < 3 years back that required systemic treatment. If diagnosed with other invasive cancer ≥ 3 years, should have complete recovery from all systemic toxicity except neuropathy and alopecia
PSCI-22-042: M23-362 Epcoritamab monotherapy R/R DLBCL or Classic FL (Previously Grade 1-3a) outpatient
The purpose of this voluntary research study is to optimize the approach to safely administer a study drug called epcoritamab in the outpatient/non-hospital setting.
Complete interview, questionnaires, and subject diaryECGClinical laboratory testsBiopsy sample, archival or freshCT/PET-CT/MRITreatment of epcoritamab
Adult male or female, at least 18 years old
Diagnosis of R/R DLBCL or R/R FL grade 1, 2, or 3a, with documented CD20+ mature B-cell neoplasm according to WHO classification 2016 or WHO classification 2008 based on representative pathology report
Subject must have 1 or more measurable disease sites: Fluorodeoxyglucose (FDG)-avid lymphomas:
Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2
inadequate organ functions
central nervous system involvement
history of primary mediastinal lymphoma.
history of severe allergic or anaphylactic reactions to anti-CD20 monoclonal antibody therapy.
A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C mutation (MRT849-001)
This study is to determine the maximum tolerated dose (MTD) of MRTX849 using one or more dosing regimens. The regimens includ using MRTX849 or in combination with Afatinib, Cetuximab, or Pembrolizumab. The study will also look at how it can be tolerated MRTX849 when its taken with food.
If you take part in this research, your major responsibilities will include: •Keep your study appointments and complete all study assessments. If you cannot keep anappointment, please contact study personnel (your study doctor or study staff) as soon aspossible to schedule a new appointment.•Inform your study personnel about any symptoms, changes in medications, doctor's or nurse'sappointments, or hospital admissions that you may have had.•Agree to not participate in any other clinical research study•Inform study personnel if you believe you or your partner might be pregnant•Inform study personnel if you change your mind about participating in the study.•Inform your other doctors that you are taking part in this study.•Avoid grapefruit and grapefruit juice.•Avoid herbal medications and preparations including but not limited to St. John’s wort, Kava,turmeric/curcumin, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA),yohimbe (yohimbine), saw palmetto, and ginseng.•Avoid medications that are processed by liver enzymes, your doctor will counsel you on these.•Avoid medications known to have risk of changing the electrical activity in the heart, your doctorwill council you on these.•For your safety, you must tell the study doctor or nurse about all the prescription drugs, herbalproducts, over-the-counter drugs (OTC), vitamins and other supplements you are taking.Check with the study doctor before starting any new medicines (including prescription, OTCdrugs, vitamins and herbal supplements) or changing doses of medications that you arealready taking.
Unresectable or metastatic disease.
Presence of tumor lesions to be evaluated per RECIST 1.1:
Life expectancy of at least 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status in 0 or 1.
Patients with carcinomatous meningitis
History of significant hemoptysis or hemorrhage within 4 weeks of the first dose date
Undergone major surgery within 4 weeks of first dose date
History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications
Dysgeusia and Anosmia in Head and Neck Cancer Patients: Long Term Outcomes
The primary aim of this study is to understand taste changes after head and neck cancer treatment, especially long term taste disturbance, using various methods including online surveys, Teams interviews, at home taste and smell tests, and MRIs.
The purpose of this voluntary research study is to identify taste changes in patients treated for head and neck cancer. We are recruiting healthy participants over the age of 40 as well as head and neck cancer survivors who were treated 3 or more years ago. The overall study consists of multiple parts, which are explained along the way. You can choose to participate in this portion, which is an online survey, and nothing else, or all of the invited components. •The survey will take approximately 10 minutes of your time. •Completion of this survey is voluntary and you are not required to complete it if you do not wish to do so.•At the end of the survey you will be asked about your willingness to participate in other portions of this study. These include at-home taste and smell tests over Teams and a Teams interview about your taste and smell function. Participating in these tasks is optional and not required. If you complete the smell and taste tests at home you may be invited to have an MRI scan.
Max of $75: No compensation for the survey, $15 giftcard for 1-hour interview (optional), $15 giftcard for at-home taste/smell tests (optional), $50 giftcard for MRI at Hershey Med Center (optional).
Over the age of 40
English Speaking
have undergone a total glossectomy
currently have an upper respiratory infection, sinus infection, or ear infection
PSCI-22-063: NRG-GU011 NRG Promethean
This trial is comparing radiation therapy with or without hormone therapy in men with prostate cancer.
Patients must come in for all radiation treatments. Patients must take their androgen therapy as prescribed.
Age ≥ 18 years.
ECOG Performance Status 0-2 within 120 days prior to registration.
External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites.
Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.
Currently on androgen deprivation or anti-androgen therapy.
Osseous metastasis on 99mTc radionuclide bone scan
Extra pelvic nodal/soft tissue disease (> 1.5cm in short axis) on CT or MRI pelvis +/- abdomen
Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
AYA-CONNECT: A qualitative study to inform creation of a social network-based peer intervention for adolescent/young adult cancer survivors
In this study, in Aim 1 we will conduct focus groups of adolescent/young adult cancer survivors (AYACS) (at least 15 total AYACS) 15-25 years old to understand their perspectives on the importance of peer connection and social connectedness during and after cancer treatment, the role of an intervention to foster peer connections, and suggestions/feedback on designing AYA-CONNECT (an AYACS-peer network intervention) including delivery format, structure, and content to promote life goals and health-related behaviors. In Aim 2 we will further explore ways to design AYA-CONNECT through interviews of pairs of AYACS and a nominated peer.
You will participate in one focus group and/or interview that will last about 1 hour.
$40
Participant is receiving or has received any oncologic care at Penn State Health Children’s Hospital or Penn State Cancer Institute
Participant fluency in written and spoken English for participants > 18 years old
Parent and participant fluency in written and spoken English for participants < 18 years old
Access to computer or smartphone
Participants with cognitive or physical inability to participate in study
BCC020: A Dose Escalation Study Using Difluoromethylornithine(DFMO) and AMXT-1501 followed by a Randomized Controlled Trial of DFMO with or without AMXT-1501 for Neuroblastoma, CNS Tumors, and Sarcomas
The purpose of this study is to evaluate the investigational drug AMXT-1501 (a pill taken by mouth) in combination with the study drug difluoromethylornithine (DFMO) for infusion administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins). An investigational drug is one that has not been approved by the U.S. Food & Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.
You will undergo a number of standard tests and research-related procedures before being able to enroll on this study.
PSCI 24-040 A NON-RANDOMIZED PROSPECTIVE CLINICAL TRIAL COMPARING THE NON-INFERIORITY OF SALPINGECTOMY TO SALPINGO-OOPHORECTOMY TO REDUCE THE RISK OF OVARIAN CANCER AMONG BRCA1 CARRIERS [SOROCk]
This protocol is comparing two types of surgery, one with the removal of the ovaries, fallopian tubes and uterus against removal of the fallopian tubes and uterus in subjects how are between 35 and 50 with the BRCA1 mutation..
Participants must be carriers of the BRCA1 gene mutation. This trial involves going to the operating room to have either their fallopian tubes removed or their ovaries and fallopian tubes removed. A vaginal ultrasound will be done. you will have blood drawn and a pregnancy test done. This will happen before surgery.
At least one intact ovary and fallopian tube
Positive CLIA-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient.
Patients may be premenopausal or menopausal.
Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration.
Prior history of ovarian cancer,
Patients medically unfit for the planned surgical procedure.
Patients with abnormal screening tests
PSCI-23-089: CAFs (Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC): a Phase I/II study
Researchers in this trial will be using a combination of two drugs to determine if the combination will help in treating cancer by shrinking tumors and controlling cancer growth.
You will need to come to the clinic for at least six visits while you are taking the study medication. Those visits will include see the study doctor, having blood drawn, and giving you the study drug. When you are no longer taking the study drug you will be seen about 2 months after that followed by phone follow ups between 6 and 8 months after stopping the study drug and then every year for 2 years. Those yearly visits can also be done by looking at you medical record.
Men or women at least 18 years of age with histologically or cytologically confirmed non-small cell lung cancer.
Previous history of other than lung cancer is allowed if no active treatment for that cancer within 1 year
Life expectancy of at least 6 months
Recurrent Unresectable stage III NSCLC treated with prior chemoradiation followed by maintenance PD1/PDL1 inhibitor with measurable disease.
Has uncontrolled diabetes.
Has a history of any Grade 3 or 4 toxicities to a prior checkpoint inhibitor treatment.
Is pregnant or breast feeding.
Has drug-induced pneumonitis ( e.g. from amiodarone, methotrexate or nitrofurantoin)
A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)
Participants in the PIVOT-006 study will either receive surgical treatment plus cretostimogene or surgical treatment alone.This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by CG0070 vs TURBT for the treatment of patients with IR-NMIBC.The purpose of this study is to see if cretostimogene can reduce the risk of your bladder cancer returning, or coming back as quickly as if you did not receive cretostimogene. People in the study will continue to be monitored by cystoscopy and pathology to see how long it takes for thecancer to return.Who May Be Eligible to Take Part In This Study:People with:• Bladder Cancer that has not invaded the muscle (Non-Muscle Invasive Bladder Cancer) • Intermediate-Risk Disease • Over 18AllTreatment:18All patients will receive surgical treatment on study as part of Standard-of-Care. 50% of patients will receive cretostimogene in addition to surgical treatment. For patients who do not receive cretostimogene, you will be offered cretostimogene if your bladder cancer recurs. The treatment will be instilled into the bladder through a thin tube called a catheter. This will be done 14 times over an 12-month period.Main Meausure:Patients who have recurrence of bladder cancer after receiving surgery plus cretostimogene compared to patients who receive surgery alone.
if you decide to take part in this study and meet all of the requirements, all patients will receive surgical treatment on study as part of Standard-of-Care. 50% of patients will receive cretostimogene in addition to surgical treatment. For patients who do not receive cretostimogene, you will be offered cretostimogene if your bladder cancer recurs. You will receive 6 treatments, once per week for 6 weeks in a row. The treatment will be instilled into the bladder through a thin tube called a catheter. This will be done 14 times over an 12-month period. There will be up to 16 visits with blood draw and/or urine colelction. As a part of screening, efficacy and follow up for this study, you might have to have cystoscopy ( up to 6), urine cytology (up to 6), TUBRT or vladder mapping or CT urogram over a 3 year month period.
Intermediate-Risk Disease
Is ≥18 years of age on day of signing informed consent.
Demonstrates adequate organ function
Is willing to comply with study mandated cystoscopies, urine cytology, CT urograms, TURBTs/biopsies, and other procedures
Has disease that cannot be completely resected.
Has current or history of muscle-invasive cancer or locally advanced or metastatic bladder cancer
Has a history of High-grade or Low-Grade urothelial cancer
Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of randomization.
A randomized, open-label, multicentric, two-arm pivotal trial of SonoCloud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma
We are asking you to take part in this voluntary research study because you have a brain tumor (glioblastoma) that has gotten worse despite first treatment.The purpose of this voluntary research study is to is to learn if the SonoCloud-9 (SC9) implantable device can be used in combination with Carboplatin chemotherapy to help control glioblastoma at recurrence. Neither Sonocloud-9 (SC9) in combination with Carboplatin chemotherapy is not FDA approved.
As part of your routine care, you will be asked to undergo surgery to remove the tumor that has come back. You will be randomized into one of the treatment groups. If you are in the study drug group the surgeon will insert the SonoCloud-9 device (SC9) implant into the skull bone at the end of the tumor resection surgery. If you are in the routine treatment group, the surgeon will close the wound without implanting the SC9 device.The treatment itself will start within 12 to 21 days after the randomization.-If you are in the study drug group you will receive up to 7 doses (every 3 weeks) of Carboplatin at the same time the SonoCloud-9 device is being activated. Further details on the procedures are described below. A brain MRI (Magnetic Resonance Imaging) scan will be performed after the first cycle as part of the research to evaluate opening of the BBB (blood-brain barrier). -If you are in the routine treatment group, you will receive up to 4 doses of Lomustine (every 6 weeks), or, if considered as best appropriate, up to 6 doses of Temozolomide (every 4 weeks). Additional in-person hospital visits or telehealth consultations by video or phone will be performed at regular intervals.
$350.00
Received prior first line therapy
First disease progression
Proven glioblastoma
At least 18 years old
Medical need to be on continued anti-platelet aggregation therapy or coagulation
Peripheral neuropathy
Uncontrolled epilepsy
Known sensitivity/allergy to gadolinium
PSCI 24-079 THE PHASE III ‘HIGH FIVE TRIAL’ FIVE FRACTIONRADIATION FOR HIGH-RISK PROSTATE CANCER
This trial is comparing disease free survival using standard radiation versus higher doses of radiation to the prostate to prevent the cancer from spreading.
Participants will be chosen to enroll into one of two types of radiation to treat their prostate cancer. they must agree to keep all appointments over the 5 years period and agree to be contacted every year for follow up.
High-risk disease
Prostate gland volume less than 100 cc prior to initiation of ADT
o definitive clinical or radiologic evidence of metastatic disease
Age ≥ 18
No prior radical prostatectomy;
Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both LHRH agonist and oral anti-androgen) is ≤ 185 days prior to registration;
BCC021: Phase I/II study of Silmitasertib (CX-4945) in combination with chemotherapy in children and young adults with relapsed refractory solid tumors
The purpose of this study is to evaluate the investigational drug Silmitasertib (CX-4945) (a pill taken by mouth) in combination with chemotherapy drugs standardly used for your tumor type. An investigational drug is one that has not been approved by the U.S. Food & Drug Administration (FDA), or any other regulatory authorities around the world for use alone or in combination with any drug, for the condition or illness it is being used to treat.
You will undergo a number of standard tests and research-related procedures before being able to enroll on this study.
PSCI 23-110 CA209-6K6 An open label, randomized study of neoadjuvant nivolumab and chemotherapy, with or without sub-ablative stereotactic body radiation therapy, for resectable stage IIA to IIIB non-small cell lung cancer
We are asking you to take part in this voluntary research study because you have lung cancer that will require surgery, chemotherapy, and possibly immunotherapy. The study involves chemotherapy and immunotherapy given during the 6 weeks prior to surgery.
In person visits for Screening, Treatment and Follow-up visits. Treatment is given monthly on day 1,22 & 43. Special test will be conducted at these time periods such as Physical Exam, Blood Draws and CT/Pet scans.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Written informed consent and HIPAA obtained from the subject prior to performing any protocol-related procedures
Evidence of post-menopausal status or negative urinary or serum pregnancy test for female premenopausal patients.
Hemoglobin ≥ 9.0 g/dL
Current or prior use of immunosuppressive medication within 14 days before the first dose of nivolumab, with the exceptions of intranasal, inhaled, topical steroids
Patients with Grade ≥2 neuropathy
History of allogeneic organ transplant.
History of hypersensitivity to nivolumab or any excipient
The Application of Mixed Methods and Social Network Analysis to Develop a Novel Measure of Social Connectedness for Adolescent/Young Adult Cancer Survivors (AYACS)
The purpose of this voluntary study is to evaluate adolescent and young adult cancer survivors’ (AYACS) social network changes over the first year after being diagnosed with cancer. This study is also exploring difference is AYACS’ social networks based on rurality. With this information, a better understanding on rural and non-rural AYACS’ social networks will be used to improve care and available resources.
As a study participant, you will complete two study visits—one after cancer diagnosis and the second one year after cancer diagnosis. Both visits should take up to about one hour and can be completed both in person and remotely. Each visit will entail the following activities: oA 30-minute interview over a secure video conference software (Microsoft Teams). The session will be audio and video recordedoSome of your contact and medical/demographic information will be collected via chart review and/or a survey. This includes but is not limited to phone number, email, race, gender, insurance, diagnosis, and other common demographic information.oNetwork Canvas social network analysis “interview” (the program’s term for a survey)oSurveys assessing social isolation and emotional support
$100.00
Within 120 days of cancer diagnosis
Participant receiving cancer treatment at Penn State Health
United States resident and English speaking
Access to computer or smartphone
Cognitive inability to participant in study
PSCI 24-077 A Phase 1b/2 Study Assessing the Safety and Efficacy of Evexomostat (SDX-7320) in Combination with a PI3K Pathway Inhibitor plus Fulvestrant in Postmenopausal Women with Advanced Breast Cancer and PI3K Pathway Alterations Who Have Progressed on or Following Endocrine Therapy plus a CDK4/6 Inhibitor
this trial is looking at introducing a medication to control blood sugars elevations caused by CDK inhibitors.
Participants must agree to come to all study visits, report any new medications to the study team, agree to having blood work done at least 8-12 hours after eating something, take study medication as directed.
Patient with histologically and/or cytologically confirmed diagnosis of HR+, HER2- breast cancer, as determined by the local laboratory.
Patient has identified PI3K pathway
Patient has locally advanced (not amenable to curative therapy or metastatic) breast cancer meeting any of the following categories:
Patient has measurable disease
Patient has known primary brain malignancy,
Patient has a known hypersensitivity to evexomostat, fulvestrant, alpelisib or capivasertib, or to any of their excipients.
Patient has had major surgery within 30 days
Patient has uncontrolled human immunodeficiency virus (HIV) infection.
PSCI 24-013 A RANDOMIZED PHASE II, DOUBLE-BLIND, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF AUTOGENE CEVUMERAN PLUS NIVOLUMAB VERSUS NIVOLUMAB AS ADJUVANT THERAPY IN PATIENTS WITH HIGH-RISK MUSCLE-INVASIVE UROTHELIAL CARCINOMA
This trial is looking at what happens to muscle invasive bladder cancer when adding cevumeran to Nivolumab
Participants will be required to keep all study appointments, tell the study doctor about all medications they are taking, report any side effects to the study doctor.
$202 for each visit completed
Surgical resection of muscle-invasive UC of the bladder or upper tract
Cisplatin ineligible
Absence of residual disease and absence of metastasis,
ECOG performance status of 0 or 1
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
Any prior neoadjuvant immunotherapy
Adjuvant chemotherapy or radiation therapy for UC following surgical resection
Absence of spleen
BCC022: Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
The purpose of this research is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the FDA approved drug, naxitamab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins).
You will be asked to come in for screening and at the start of each cycle (every 28 days), and at the end of study treatment to have tests done (these may include a physical exam, blood tests, and electrocardiogram [ECG]). During the first cycle you will need to have blood tests done weekly. You will also need to come in during Days 1-5 of each cycle to receive the study treatment. You will also have scans and a bone marrow biopsy (tissue sample) and aspirate (fluid and cells) done at the start of study, every 2 cycles, and at the end of study.
Age >12 months of age at enrollment
Age 6 years or older for safety run in
Currently receiving another investigational drug
A Confirmatory Phase 3 Mutlicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL).
The purpose of this trial is to evaluate the safety and efficacy of 18 weeks of HyBryte (topical gel) treatment in combination with visible light therapy in subjects with cutaneous T-cell lymphoma when compared to placebo (no active ingredient). Cutaneous T-cell lymphoma (CTCL), of which the most common early stages are also known as mycosis fungoides (MF), is the most common type of T cell lymphoma. Participants will be enrolled in this trial for 30 weeks and will follow up at the clinic site every 4 weeks following the last trial treatment for a total of 12 weeks.
Participants will attend in person visits over 30 weeks. At different timepoints throughout the study participants will have their skin evaluated and photographed, have blood drawn, have an ECG done, and apply the study medication as directed by the study team.
Participants must have a minimum of 3 evaluable, discrete lesions
Participants must be willing to follow the clinical protocol and voluntarily give their written informed consent
Participants with extensive skin disease may not be eligible to participate; investigator will discuss during skin evaluation
Certain medical conditions may not be eligible to participate; study coordinator will discuss further.
PSCI 24-018 Phase 1, open label clinical trial to treat Stage IV cancer patients with multiple patient-specific mutated cell surface proteins with chimeric antibodies
This study will examine if giving patients their cells that have been modified in the lab will help control their cancer.
Subjects will be required to come to all visits. Each treatment will take 2-5 hours and there will be a total of 10 treatments over a 14 week period.
Subjects who have refractory or progressive disease after at least 1 line of systemic treatment
Subjects must have measurable disease
Known human immunodeficiency virus infection.
Subjects who have received any cytotoxic treatment within 3 weeks of antibody treatment.
Subjects who have received any radiotreatment to the primary sample site within the last 14 days
Research on Survivorship Experiences: Disparities in cancer-related outcomes between rural and non-rural cancer survivors in the catchment areas of the Big 10 Cancer Research Consortium's Population Science Working Group
The objective of this cross sectional survey study is to describe the social and psychological outcomes of cancer survivors and characterize the disparities between rural and non-rural cancer survivors. We will collaborate will members of the Big 10 Cancer Research Consortium's Population Science Working Group to invite cancer survivors in rural and non-rural communities to complete one online survey, with each site targeting cancer survivors in their catchment areas. At Penn State, we will target recruitment to cancer survivors living in Pennsylvania. We plan to enroll 150 participants. It will take participants 30-40 minutes to complete the study and they will receive a $15 Amazon gift card for their time and effort.
If eligible, study participants will be asked to complete one online survey about their experience as a cancer survivor. Potential participants will first complete a REDCap screening form, if eligible, they will view the consent form. If they provide consent, they can complete the survey. A member of the Penn State study team will call the participant to confirm eligibility and once confirmed, will issue a $15 Amazon e-gift card. The entire study should take between 30-40 minutes to complete.
$15
non-metastatic cancer
1-5 years post completion of active treatment
no current evidence of cancer
living in certain counties in south central Pennsylvania
cannot speak or read English
unable to provide informed consent
less than 18 years old at time of cancer diagnosis
Maintenance Obinutuzumab for primary central nervous system lymphoma complete or partial responders
The study will compare participants with primary central nervous system lymphoma which responded to initial treatment and are thereafter treated with Obinutuzumab (the study drug), with participants with primary central nervous system lymphoma which responded to initial treatment and are not treated with the study drug.
In addition to your routine care, you will be “randomized” into one of the study groups described below. You will have a MRI of your brain approximately every three months (plus or minus two weeks) for two years. You will undergo a neurocognitive assessment and complete a quality-of-life questionnaire two years after study entry.Group A – Obinutuzumab ArmIf you are in the first group ("Group A") you will be given the study drug every two months for two years. Every two months you will have your vital signs taken, your blood drawn (one to two tablespoons), and you will be given the study drug through an IV infusion into your vein. Group B – No Obinutuzumab ArmIf you are in the second group ("Group B") every six months you will have your vital signs taken and your blood drawn (one tablespoon).
Must have undergone first-line treatment with high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy
Must be within 75 days of completion of first-line treatment regimen at the time of randomization
18 years or older
Clinical evidence of extra-CNS (systemic) non-Hodgkin lymphoma.
Known hypersensitivity to any of the study drugs.
History of other malignancy that could affect compliance with the protocol or interpretation of results
Known active bacterial, viral, fungal, mycobacterial, or other infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization
PSCI 24-139 NRG-BN013: PHASE III TRIAL OF SINGLE FRACTION STEREOTACTIC RADIOSURGERY (SRS) VERSUS FRACTIONATED
This trial will examine if disease progression improves with Fractionated vs. Steriotactic Radiosurgery.
Participants must agree to the type of radiation they are randomized, keep all appoiintments and rpoert any side effects.
Patients must have at least 1 and up to 8 total intact brain metastases
All brain metastases must be located outside of the brainstem
No more than 2 lesions planned for resection
No known leptomeningeal disease
No prior radiotherapy to the brain
No active infection
No hepatic insufficiency
No chronic obstructive pulmonary disease exacerbation
PSCI 23-002 CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients with ER+/HER2-Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease
We are asking you to take part in this voluntary research study because you have ER+/HER2- early breast cancer with no evidence of disease following surgery. The purpose of this voluntary research study is to better understand the studied disease and associated health problems.
Participants will be required to come to all study visits, take the medication an instructed, let the study team know what medications you are taking, especially over the counter ones and to report any changes in how you are feeling.
Patient must be ≥18 years
histologically confirmed ER+/HER2- early-stage resected invasive breast cancer
a history of previous breast cancer
Chronic gastrointestinal disease
Major surgical procedure or significant traumatic injury within 2 weeks of randomisation
PSCI 24-041 Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence—A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)
This trial will compare the use of elacestrant versus standard endocrine therapy in those who are node positive, ER +, Her2 - with high risk of the cancer coming back
Participants will be expected to come to all visits, take all study medication as instructed by the study doctor, report any new medications, prescription or over the counter, report all side effects.
Histopathologically or cytologically confirmed ER-positive (≥ 10% by immunohistochemistry [IHC]), HER2-negative [IHC = 0 or 1, or (IHC = 2 and ISH-negative)]
Participants considered at high risk of recurrence
Participants who have received at least 24 months but not more than 60 months of endocrine therapy
Participants are to be between 2 to 6 years from the date of curative surgical resection
Participants with stage IV metastatic breast cancer.
History of any prior (ipsilateral and/or contralateral) invasive breast cancer
Major surgery within 4 weeks of starting study therapy