Search Results Within Category "Cancer"
A Phase I/II Study of Neratinib in Pediatric Patients with Relapsed/Refractory Solid Tumors
Neratininb for childhood cancer that has returned or is not responding to previous therapy
Cancer that has returned or is not responding to previous therapy
Has failed at least one prior therapy
PHASE I SAFETY ASSESSMENT OF HYPOFRACTIONATED POSTOPERATIVE RADIOTHERAPY (H-PORT) FOR INTERMEDIATE-RISK HEAD AND NECK CANCER
The purpose of this study is to test the good and bad effects of using hypofractionated radiation therapy. Hypofractionated radiation therapy could shrink or stabilize your cancer, but it could also cause side effects. The study doctors hope to learn if hypofractionated radiation therapy is safe and tolerable in patients with your type of cancer. You will receive radiation therapy for 4 weeks. You may also receive chemotherapy.
Participants will be required to receive radiation therapy for 4 weeks. Participants may also receive chemotherapy with cisplatin, carboplatin, or cetuximab.
Clinical stage II, III or IVA squamous cell carcinoma of the oral cavity, oropharynx or larynx (AJCC 8th edition), including no distant metastases.
Total resection of the patient’s cancer (i.e. no residual disease after total resection of the patient’s cancer ).
One or more indications for postoperative radiotherapy, based upon pathologic findings: • Perineural invasion; • Lymphovascular invasion;
Zubrod Performance Status 0-1
History of systemic lupus erythematosus or systemic sclerosis (scleroderma).
Pregnancy and individuals unwilling to discontinue nursing.
Feeding tube (gastric or jejuno) at the time of registration.
Anticipated need for high-dose systemic chemotherapy (e.g. high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy. Weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable.
UroGen UR001
This study is being done is to test the safety of a drug called UGN-301 at different dose levels, either alone or with another drug called UGN-201, and to understand how these drugs interact with the bladder and body
If you decide to take part in this study and meet all of the requirements, you will receive 6 treatments, once per week for 6 weeks in a row. The medication treatments will be instilled via catheter into your bladder. There will be 11 total visits with blood draws at all of the visits. As part of screening for this study you will have to have a CT scan, a cystoscopy, and a bladder biopsy. At 3 months you will be required to return for a cystoscopy and bladder biopsy if necessary. Finally, there will be a follow up cystoscopy and bladder biopsy at 6 months.
Have confirmed recurrent NMIBC with HG Ta disease and/or CIS
Has a life expectancy > 12 months.
Be post menopausal, surgically sterile, or using a combination of 2 methods of birth control for maximally effective birth control
Have adequate organ and bone marrow function within 14 days of treatment initiation as determined by routine laboratory tests
Current or previous evidence of muscle invasive, locally advanced nonresectable, or metastatic urothelial carcinoma (ie, T2, T3, T4 and/or stage IV). High or low grade T1 disease.
Current systemic therapy for bladder cancer.
History of malignancy of other organ system within the past 5 years. Patients with genitourinary cancers other than urothelial cancer or prostate cancer that are under active surveillance
Prior therapy with an anti-CTLA-4, anti-PD-1, anti-PD-L1 agent, or with an agent directed to another co-inhibitory T-cell receptor.
PSCI 21-158 Radiopaque Hydrogel Rectal Spacer for Prostate Cancer Radiation Image Guidance
Prior to enrollment, potential subjects will be evaluated during the Screening Period to determine eligibility. The following assessments will be performed during the Screening Period:●Review of eligibility ●Placement of hydrogel spacer and fiducial marker after eligibility is determined Visit 2 or Day 2 or Post-test - Radiotherapy per standard of care.
Prior to enrollment, potential subjects will be evaluated during the Screening Period to determine eligibility. The following assessments will be performed during the Screening Period:●Review of eligibility ●Placement of hydrogel spacer and fiducial marker after eligibility is determinedVisit 2 or Day 2 or Post-test - radiotherapy per standard of care
N/A
N/A
N/A
N/A
Prior prostate surgery
Prior prostate radiotherapy
N/A
N/A
PSCI 23-012 THE JANUS RECTAL CANCER TRIAL: A RANDOMIZED PHASE II TRIAL TESTING THE EFFICACY OF TRIPLET VERSUS DOUBLET CHEMOTHERAPY TO ACHIEVE CLINICAL COMPLETE RESPONSE IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER
This trial is using long course chemoradiation in combination with three different chemotherapy treatments to treat rectal cancer. Once therapy is completed patients will either have surgery or watch and wait. The goal is to see which therapy is better in achieving a complete response, if any.
Patients will be expected to come to the clinic for all radiation treatments and all chemotherapy treatments.
Tumor Site: Rectum; ≤ 12cm from the anal verge
No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed.
Not pregnant and not nursing,
Age ≥ 18 years
No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
No known mismatch repair deficient rectal adenocarcinoma
PSCI 22-114: A PHASE 2/3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF NKTR-255VS PLACEBO FOLLOWINGCD-19 DIRECTED CAR-T THERAPYIN PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA.
This is a drug study that will evaluate how well the investigational drug works compared to a placebo following CAR-T cell therapy. Participants will be required to keep all your scheduled visits, receive drug treatment, blood draws, imaging, and possibly a tumor biopsy.
Participants will be required to receive the study treatments including CAR-T infusion, blook tests, imaging, tumor biopsy, and study medications.
Received standard of care therapy with axi-cel or liso-cel (Stage 1 and Stage 2), or tisa-cel (Stage 2 only)
Received lymphodepleting chemotherapy regimen according to the respective FDA (or SmPC) label for CAR-T cell therapy.
Fluorodeoxyglucose (FDG)-avid disease on PET imaging within 30 days prior to CAR-T cell infusion
FDG avid lesion(s) on PET/CT scan following bridging therapy and prior to lymphodepletion, where applicable.
Prior treatment with any CD19-directed CAR-T cell therapy other than the treatment planned per Inclusion Criterion 2.
For allogeneic hematopoietic cell transplant recipients, active graft versus host disease (GVHD) and/or systemic GVHD therapy during screening or up to 30 days prior to leukapheresis.
Known active hepatitis B (detectable hepatitis B DNA) or hepatitis C (detectable hepatitis C RNA).
Known human immunodeficiency virus (HIV) infection
An Intermediate Expanded Use Trial of DFMO(eflornithine HCl)
This research study is to provide expanded access to a new investigational drug DFMO (difluoromethylornithine) for patients with neuroblastoma, medulloblastoma, and certain rare tumors that have no other curative options. DFMO is an oral drug that inhibits a certain enzyme (protein) in blood which is associated with a bad outcome in neuroblastoma cases. Cancer cells have pathways that drive the cancer to grow and DFMO targets the specific pathway of this enzyme to turn these cells off.
If you are enrolled on this study, DFMO will be started in clinic on Day 1. After this first day you will be seen in clinic approximately once every 30 days for the first 6 months of study and once every 90 days for the last 18 months of study. These visits will last about 2 hours, and involve a physical exam, blood tests, and other testing.
Not eligible for DFMO studies NMTRC014, BCC015, or BCC016
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Safety and Efficacy of IGV-001, an Autologous Cell Immunotherapy With Antisense Oligonucleotide (IMV-001) Targeting IGF 1R, in Newly Diagnosed Patients With Glioblastoma
The purpose of this study is to see how safe the study medicine, IGV-001 plus standard of care (SOC), is and to compare IGV-001 with placebo (only standard of care) to see if it works in slowing GBM tumor regrowth.SOC refers to the usual medicine(s) or procedures used to treat this cancer.
You will be randomly assigned by chance, like rolling a pair of dice - to receive either IGV-001 or placebo (inactive substance) that will be placed into biodiffusion chambers [dime-sized containers] and surgically implanted in your belly area for approximately 48 hours and then removed. You will have a 66.6% (2 in 3) chance of receiving IGV-001 and a 33.3% (1 in 3) chance of receiving placebo. There is a small chance that you may not receive treatment with IGV-001 or placebo after the abdominal incisions have been made.
Is between 18 and 70 years of age at screening
Has a diagnosis of malignant glioma based on the treating neurosurgeon’s best clinical judgement defined using the patient’s symptomology, MRI scan results, and intraoperative frozen section verbal confirmation of malignant glioma.
Has adequate bone marrow and organ function at screening
Has received any previous surgery for tumor removal of GBM
Has recurrent glioma, a concurrent malignancy
Has any severe immunocompromised condition
Is receiving any other investigational agent(s) or has received an investigational agent within 30 days prior to screening
PARPAML: A Phase 1 Protocol for Relapsed Pediatric AML to Determine the Safety and Efficacy of the PARP Inhibitor Talazoparib in Combination with Chemotherapy
The purpose of this study is to find out what effects, good and/or bad, study treatment with talazoparib in combination with the chemotherapy drugs topotecan and gemcitabine has on pediatric patients with acute myeloid leukemia (AML) that has returned or has not responded to treatment. The study drug talazoparib has been chosen because there is evidence that is can reduce tumor activity in a more specific way than chemotherapy.
If you join the study, you will given a certain dose of the study drug talazoparib, and of the chemotherapy drugs topotecan and gemcitabine. You may be asked to provide biological samples (such as blood or bone marrow) and undergo procedures that might be different from a regular medical examination. This study will involve screening, treatment, and follow up period. During screening, the study doctor will determine whether you are eligible for the study. If you are eligible and are enrolled into the study, you will have 2-3 months of active participation, including collection of information from you, admission to the hospital for a minimum of 5-7 days, and at least weekly visits to the study center.
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 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects with Relapsed/Refractory Follicular Lymphoma
The purpose of this study is to determine how effective and safe axi-cel is compared to standard of care, specifically chemo-immunotherapies, and use this information to determine the best choice of treatment in Subjects with Relapsed/Refractory Follicular Lymphoma
Attend all study visits receive study drug or SOChave blood drawn for various testsECHO or MUGA, ECG, PET/CT, and MRI if neededbone marrow biopsy if neededComplete questionnaires
R/r disease as defined as one of the following options: a) First-line systemic chemoimmunotherapy and high-risk disease, defined as relapse or progression within 24 months of initiation of the initial course of chemoimmunotherapy (ie, POD24)
Clinical indication for treatment local symptoms due to progressive or bulky disease, systemic B symptoms, compromised organ function due to disease progression, cytopenias due to marrow involvement, or symptomatic extranodal disease.
At least 1 measurable lesion per the Lugano Classification
No known history or suspicion of central nervous system (CNS) lymphoma involvement
FL Grade 3b
Small lymphocytic lymphoma
Lymphoplasmacytic lymphoma
Full-thickness involvement of the gastric wall by lymphoma
A Phase II Study of Naxitamab Added to Induction Therapy for Subjects with Newly Diagnosed High-Risk Neuroblastoma
This study is being done to learn if it is safe to add naxitamab to standard therapy during the Induction phase of care for patients with newly diagnosed high-risk neuroblastoma. Naxitmab is an immunotherapy agent which trains your immune system to target your tumor in a more specific way than chemotherapy does.
This study has 3 phases- screening, treatment, and follow up. If you join the study, during screening we will test a sample of your tumor along with your blood. The tumor sample will be obtained at the same time as you are having surgery or a biopsy. Other testing will be done to make sure you are eligible to receive treatment. If you are eligible for treatment, you will receive five 21 day cycles of anti-cancer medication (induction chemotherapy) along with naxitamab. You will have to stay in the hospital to receive this treatment for at least 6 days of each 21 day cycle. If your screening testing also shows a certain genetic change in your tumor, we may also add a medication that is targeted at that change. If your tumor does not respond adequately to the initial cycles, we may give up to three additional 21 day cycles of chemotherapy with naxitamab. You will also have procedures at certain timepoints during induction that are standard of care for your tumor. These include collecting stem cells for use later in your therapy after Cycle 2. After Cycle 4, you will have surgery to remove as much of the tumor as possible. The treatment phase will last about 8 months, after which you will be in follow up. During your time on the study, we will ask to collect research samples of blood, bone marrow, and tumor. We will be monitoring your progress and health throughout your time on treatment and in follow up.
≤ 21 years of age at initial diagnosis and > 12 months of age at time of enrollment
Receiving any investigational drug
PSCI 23-092 EA8192 A Phase II/III trial of Durvalumab and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
This trial is comparing outcomes of cisplatin eligible vs cisplatin ineligible high grade urothelial cancer patients treated with accelerated therapy vs gemcitabine and durvalumab followed by surgery.
Participants will need to complete all study visits, agree to having surgery and to make sure to tell the study team if they are having any side effects.
Patient must have the ability to understand and the willingness to sign a written informed consent document
Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy
Patients must not have any component of small cell/neuroendocrine carcinoma
Patients must not be pregnant or breast-feeding
Patient must not have another active (or within two years) second malignancy
Patient may have a history of resectable urothelial cancer
Patient must not have any uncontrolled illness
Patient must not have received prior systemic anthracycline therapy
PSCI 22-132 A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors
The purpose of this voluntary research study is to evaluate potential new anticancer to treat people with tumors similar to yours. This study will provide information about the safety, the ability of your body to accept the study drug(s), the amount of study drug(s) and/or break-down products in your blood, and your body’s reaction to the study drug(s). Participants will be required to take study medication, have blood drawn, and have imaging tests such as CT, MRI, ECG, MUGA, ECHO, and bone scans.
Participants in the expansion stage will receive study treatment, imaging exams (ECHO, MUGA, ECG, CT, MRI, bone scans), blood draws, tumor assessments, and tumor tissue samples.
For all Expansion Cohorts except Cohort 3 (mCRPC): Measurable disease per RECIST
For Expansion Cohorts only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.
Recovery to baseline or ≤ Grade 1 CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
Age 18 years or older on the day of consent
Cohort 2 (ccRCC 2L), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC, 2L+), and Cohort 10 (CRC, 2L+): Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.
For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.
Receipt of any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before first dose of study treatment.
Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.
PSCI 23-099 NRG-BR009: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancerand an Oncotype Recurrence Score ≤ 25 (OFSET)
To determine if chemotherapy added to ovarian suppression and endocrine therapy is better than endocrine therapy and ovarian supression alone.
Subjects will be required to keep all study appointments, take the medications as required, have an annual mammogram, inform the study of any over the counter medications they may be taking.
Patients must be premenopausal
The patient must have an ECOG performance status of ≤ 2
Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
pT4 tumors, including inflammatory breast cancer.
History of ipsilateral or contralateral invasive breast cancer.
Life expectancy of < 10 years due to co-morbid conditions in the opinion of the investigator.
PSCI 22-142 A Randomized, Open-label, Phase 3 Study of Sacituzumab GovitecanVersus Treatment of Physician’s Choice in Patients With HormoneReceptor-Positive (HR+)/Human Epidermal Growth Factor Receptor2 Negative (HER2−) (HER2 IHC0 or HER2-low [IHC 1+, IHC2+/ISH−]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
This trial is to compare the effects of sacituzumab govitecan versus physician's choice in the treatment of breast cancer
Potential participants will be expected to come to all study visits, complete questionnaires, take the medication as prescribed by the study doctor, report any changes in medications of symptoms while on the trial.
Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site, either in a formalin-fixed, paraffin-embedded block or newly sectioned, unstained slides for HER2 status and other biomarker assessments.
Documented evidence of HR+ metastatic breast cancer (mBC)
Documented evidence of HER2− status
Documented PD by computed tomography (CT) or magnetic resonance imaging
Previously HER2+
Locally advanced mBC (Stage IIIc) in patients who are candidates for curative intent therapy at the time of study enrollment
Current enrollment in another clinical study
Treatment with definitive radiation within 2 weeks prior to the first dose of study drug
Genomic Profiling of Urothelial Cancers Study
The objective of this protocol is to study urothelial cancer with detailed health history, tumor and/or normal tissues available for genomic sequencing to study cancers in the bladder, upper urinary tract, and urethra. There will be 3 groups of subjects in this study:1)Urothelial cancer patients receiving care at Penn State Health2)Relatives of patients with urothelial cancer3)High risk-cohort of individuals with family history of urothelial cancers or inherited cancer syndromes (such as Lynch syndrome) candidates for urothelial cancer screening evaluation
All subjects will be asked to fill out questionnaires to assess risk factors for urinary cancer and document family history of cancer. You will be asked to provide a blood sample and urine sample for genetic testing. Patients with urothelial cancer will be asked to allow us to test leftover tissue from a past or future biopsy to test cancer and/or normal cells for certain mutations. We may also ask you for a saliva sample, cheek swab, skin biopsy, or nail clippings for comparison.
personal or family history of bladder cancer
Precision mEdicine and Adoptive Cellular tHerapy for the treatment of recurrent neuroblastoma and newly diagnosed diffuse intrinsic pontine glioma (DIPG)
This study is being done to learn if a vaccine made in the laboratory from your tumor and your immune cells is safe to give to you to treat your tumor. It is believed that the body’s immune system protects the body by attacking and killing tumor cells. T-lymphocytes (T-cells) are part of the immune system and can attack when they recognize special proteins on the surface of tumors. In most patients with advanced cancer, T-cells are not stimulated enough to kill the tumor. In this research study, we will use your tumor and immune cells from your blood to make a vaccine that we hope will stimulate your T-cells to kill tumor cells and leave your normal cells alone.
You will need routine (standard of care) testing for your tumor, as well as research tests and procedures including further analysis of your tumor sample, generation and review of a personalized genetic report, and procedures to collect certain cells for different infusions and creation of specialized cellular vaccines. You will then be offered and placed on a treatment plan. As a subject in this study you will remain in this study until you complete vaccine therapy as long as you have no disease progression or unless you need to come off study for another reason.
For Neuroblastoma must be >12 months and ≤ 30 years of age
For DIPG must be ≥ 3 years and ≤ 30 years of age
Known autoimmune or immunosuppressive disease or human immunodeficiency virus infection
PSCI 23-008: A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination with Gemcitabine in Adult Subjects with Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature® Status ACR-368-201/GOG-3082
This trial will be looking at patients with OncoSignature positive and negative tumors using the treatment of the study drug in combination with ultra low dose gemcitabine.
If you are in Arm 1, you will receive ACR-368 as a single intravenous (in the vein) infusion over approximately 60 minutes twice during a 4-week period, on Days 1 and 15. This entire 4-week period is called a cycle. If you are in Arm 2, you will receive gemcitabine and ACR-368 as two separate intravenous (in the vein) infusions. The gemcitabine infusion will last approximately 30 minutes and the ACR-368 infusion will last approximately 60 minutes. •Biopsy Sample and OncoSignature® Status•Archived Tumor Sample and Genomic Information•Physical Exam•Pregnancy Test if applicable•Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan•Blood Sampling for CA-125 (Ovarian carcinoma only)
Subject must have histologically confirmed, locally advanced (ie, not amenable to curative surgery and/or radiation therapy) or metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen.
Subject must have at least 1 measurable lesion per RECIST v1.1 criteria (by local Investigator)
Subject must be willing to provide tissue from a newly obtained tumor biopsy from an accessible tumor lesion not previously irradiated after signed informed consent.
Subject must have an estimated life expectancy of longer than 3 months.
Subject has a history of clinically meaningful coagulopathy, bleeding diathesis.
Subject had systemic therapy or radiation therapy within 2 weeks prior to the first dose of study drug.
Subject with known symptomatic brain metastases requiring > 10 mg/day of prednisolone (or its equivalent).
Subject has taken a prior cell cycle CHK1 inhibitor, including ACR-368.
Patient and Provider Preferences for Breast Cancer Treatment Side Effect Prediction
This one-time survey seeks to understand both patient and provider perspectives of and preferences for a predictive test for side effects among breast cancer patients treated with an aromatase inhibitor (AI).
Complete a one-time electronic survey asking for opinions on a predictive test for side effects of aromatase inhibitor (AI) breast cancer treatments.
New diagnosis of non-metastatic breast cancer (stage 0-III) at Penn State Health within the last 5 years
Prescribed at least one AI as part of breast cancer treatment at least one year ago
Inability to provide consent in English or Spanish
PSCI 23-121 Phase III Randomized Trial of Stereotactic ablativeradiotherapy (SAbR) for Oligometastatic Advanced RenalCarcinoma (SOAR)
This study is looking at patients with oligometastasis comparing chemotherapy and SABR with chemotherapy alone
•Blood counts and blood chemistry done at initiation and every three months to make sure you are not having any side effects from the study affecting your blood counts.•CT or MRI scans done at initiation and every three months to monitor the response of the treatment to your cancer•Physical exams done every three months to confirm your general well-being and to detect side effects from the study.Compete physical and well being form as set below:•Baseline•3 months from start of treatment•6 months from start of treatment•9 months from start of treatment•12 months from start of treatment•18 months from start of treatment•24 months from start of treatment
patient may not have brain metastases
Patient may have any RCC histology except a histology that has a sarcomatoid component.
Patient must have a pathologically (histologically or cytologically) proven diagnosis of renal cell carcinoma (RCC) prior to randomization.
Patient must have primary site addressed by local therapy. If the primary RCC is intact, the patient must undergo local treatment to the primary before randomization.
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
Patients must not expect to conceive until after 6 months after the last dose of protocol medication
Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured.
In order to participate in the QOL portion of the protocol, the patient must speak English or Spanish.
AYA-CONNECT: A qualitative study to inform creation of a social network-based peer intervention for adolescent/young adult cancer survivors
In this study, 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.
You will participate in one focus group that will last about 1 hour.
$20
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
PSCI 23-144 NRG-LU008: PHASE III PROSPECTIVE RANDOMIZED TRIAL OF PRIMARY LUNG TUMOR STEREOTACTIC BODY RADIATION THERAPYFOLLOWED BY CONCURRENT MEDIASTINAL CHEMORADIATION FOR LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER
Patients diagnosed withy inoperable node positive non small cell lung cancer will be randomized to with radiation therapy to all know sites of disease in the lung, followed by immunotherapy or radiation to the primary lung tumor, followed by radiation to the lymph nodes followed by immunotherapy
Participants will be required to come to all study visits, report to the study doctor any new medications, prescription or over the counter that they may be taking,
The patient must be deemed clinically appropriate for curative intent definitive combined modality therapy, based on the following staging assessments:
No evidence of distant metastases based on FDG PET/CT scan obtainedwithin 60 days of registration.
Primary tumor ≤ 7 cm;
Age ≥ 18;
Patients without identifiable primary tumor
Centrally located primary tumor < 2 cm from involved nodal disease which would result in significant overlap of the primary SBRT and nodal radiation fields
Participants who are pregnant or unwilling to discontinue nursing.
Participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) unwilling to use highly effective contraceptives during therapy
PSCI 23-145 Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation
This trial is comparing two different therapies for the treatment of newly diagnosed multiple myeloma who are not having a bone marrow transplant.
Subjects will be required to keep all research visits, take medications as directed, report any new medication of side effects to the study team,
Patient must be considered ineligible for autologous stem cell transplantation by the treating physician, or willing to delay stem cell transplantion until first relapse or later.
Patient must agree to register to the mandatory Celgene Revlimid REMS program and be willing and able to comply with the requirements of the Revlimid REMS program.
Patient must have standard risk MM as defined by the Revised International Staging System (R-ISS) Stage I or II.31
Patient must be able to undergo diagnostic bone marrow aspirate following preregistration if not performed previously.
Patient must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
Patient must not have moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification.
Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.
Patient must not have peripheral neuropathy ≥ Grade 2 on clinical examination or grade 1 with pain
PSCI# 24-014 OPTIMICE-PCR: DE-ESCALATION OF THERAPY IN EARLY-STAGE TNBC PATIENTS WHO ACHIEVE PCR AFTER NEOADJUVANT CHEMOTHERAPY WITH CHECKPOINT INHIBITOR THERAPY
this trial is examining what happens if a less toxic therapy is given to triple negative breast cancer subjects who's tumor is completely gone after receiving pre surgery chemotherapy.
Participants will need to come to all research visits, reports any side effects of medication, if they are taking any over the counter medications.
ECOG Performance Status 0-2
Triple Negative Breast Cancer
Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively.
An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization.
No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed.
No evidence of recurrent disease following preoperative therapy and surgery.
No known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
PSCI# 24-028 NRG-BR008: A PHASE III RANDOMIZED TRIAL OF RADIOTHERAPY OPTIMIZATION FOR LOW-RISK HER2-POSITIVE BREAST CANCER (HERO*)
This study will look at the differences in recurrence between patients who receive breast radiation after surgery to those who don't.
Participants will be required to come to all study visits, complete their radiation and chemotherapy treatments.
The patient must have an ECOG performance status of 0 ,1,
Histologically or cytologically confirmed invasive breast carcinoma.
The tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results.
The tumor must have ER and PgR status assessed locally using current ASCO/CAP Guidelines.
patients with a primary tumor >2 cm on pathologic examination of the surgical specimen
Patient planning for or status-post mastectomy.
Non-epithelial breast malignancies such as sarcoma or lymphoma.
Multicentric carcinoma (invasive cancer or DCIS)