Search Results Within Category "Cancer"
PSCI 22-156 HCRN BRE17-141
The purpose of this voluntary research study is to see if neratinib, endocrine therapy, and trastuzumab completely shrink breast tumors before having breast cancer surgery. You will need to have the following exams, tests, or procedures: blood draws, ECG, Echo or MUGA, ultrasound, MRI, receive study treatment, and breast biopsy.
Participants will be required to receive study treatments, laboratory assessments, undergo breast biopsy, and radiologic assessments,
HER2-positive (by most recent ASCO-CAP criteria)
ER > 50% and PR > 50%.
Resectable breast cancer in which pre-operative therapy is appropriate (T > 10mm and/or node-positive).
Archival tissue from the diagnostic pre-treatment biopsy is required.
Evidence of metastatic disease.
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial:
Active infection requiring systemic therapy.
Requirement for use of a moderate or strong CYP3A4 inhibitor or inducer during the study
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
A Phase Ib/II Study of APG-115 as a Monotherapy or in Combination with Pembrolizumab in Patients with Unresectable or Metastatic Melanomas or Advanced Solid Tumors
Part 1 (Phase Ib): To determine the safety and ability for subjects to tolerate APG-115 when combined with pembrolizumab, as well as the maximum tolerated dose in subjects with metastatic melanomas or solid tumors.Part 2 (Phase II): To determine the overall response rate of APG-115 when combined with pembrolizumab in the treatment of patients with unresectable or metastatic melanomas. To assess APG-115 as a monotherapy in patients with unresectable or metastatic melanomas and MPNST cohorts only.
If you are eligible and agree to receive the study drug combination, you will need to come to the study site at various times to have procedures done. These procedures may include collection of vital signs, blood andurine samples, electrocardiogram, physical exam, tumor biopsy, imagingscans, and x-ray. At each visit, you will be asked about your current medicines, including over-the-counter medications, and about any symptoms or side effects you might be having. You will receive the study drug orally on Days 1, 3, 5, 7, 9, 11, 13 of every 21-day cycle. Pembrolizumab is given as a 30-minute intravenous (IV – through a needle into a vein) infusion on Day 1 of every 21-day cycle.
Histologically confirmed, unresectable or metastatic melanoma, and refractory or relapse after PD1 antibody treatment and ineligible for other standard of care therapy
ECOG Performance scale of 0-2
Life expectancy of equal to or greater than 3 months
Adequate bone marrow and organ functionAdequate
Prior loco-regional treatment with intralesional therapy (e.g. talimogene laherparepvec) for unresectable or metastatic melanoma in the last 6 months prior to start of study treatment.
Received hormonal and biologic (<1 half-lives), small molecule targeted therapies or other anti-cancer therapy within 21 days prior to first dose Radiation or surgery within 14 days of study entry, thoracic radiation within 28 days prior to first dose.
Has known active central nervous (CNS) metastases and/or carcinomatous meningitis. Or has neurologic instability per clinical evaluation due to tumor involvement of the CNS.
Requirement for corticosteroid treatment, with the exception of megestrol, local use of steroid: i.e.: topical corticosteroids, inhaled corticosteroids for reactive airway disease, ophthalmic, intraarticular, and intranasal steroids.
CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: A Prospective, Randomized, Double-blind, Multi-center Clinical Trial
This study seeks to verify the findings of the CHARM I pilot study by conducting a multi-center clinical trial. We hypothesize that:•Pancreatic cyst infusion with a specifically designed drug therapy cocktail following normal saline lavage will result in cyst destruction rates that do not significantly differ from those achieved by alcohol-based cyst treatment (ethanol lavage followed by infusion of the same chemotherapeutic cocktail).•The removal of alcohol from the procedure will decrease both serious and minor adverse event rates associated with pancreatic cyst treatment.•There may be molecular markers contained within the fluid of these cystic tumors which identify cysts that are favorable to or resistant to EUS-guided fine needle infusion using this drug combination. As such, we will test all treated cysts for 10 of the best known molecular markers for evaluation in post study analysis. We expect that administering a specifically designed chemotherapeutic cocktail without prior alcohol lavage will result in an equivalent rate of cyst resolution with fewer complications when compared to alcohol. The results of this study will provide important information about the most efficient and safest method for treating premalignant pancreatic cysts, an important step for treating these lesions with a minimally invasive technique and preventing their progression to cancer. Standard alternative treatment options for this patient group (if not taking part in this study) would be ongoing periodic radiographic monitoring with MR or CT imaging waiting for signs of cancer to develop or to consider surgical removal of the affected tissue.
Patients will have to sign the consent form to participate in the trial
Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which are consistent with a mucinous type cyst as per ASGE guidelines including indeterminate type cysts.
Ability to give written informed consent.
Capable of safely undergoing endoscopy with deep sedation or general anesthesia.
Known or suspected pancreatic cancer or pathologic lymphadenopathy.
Cysts with the following high risk features: main pancreatic duct dilation of > 5mm,epithelial type mural nodules , pathologically thick wall/septation (> 2mm)..
Septated cysts with > 4 compartments.
Confirmed acute pancreatitis within the last 3 months.
NRG-GU007, Randomized Phase II Trial of Niraparib with Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I) (NADIR*) (NCT 04037254) (PSCI# 20-104)
The purpose of this study is to compare the usual treatment alone to using the study drug niraparib plus the usual treatment. The addition of niraparib to the usual treatment could prevent your cancer from growing or returning. But, it could also cause side effects, which are described in the risks section below. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To be better, the study approach should increase the chance of remaining cancer free to 50 out of 100 participants after 2 years, or a 20% improvement compared to the usual approach.
This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To be better, the study approach should increase the chance of remaining cancer free to 50 out of 100 participants after 2 years, or a 20% improvement compared to the usual approach.
Age is greater than or equal to 18 years old
Pretreatment serum PSA, obtained prior to any androgen suppression therapy and within 180 days of registration
Adequate hematologic, renal, and hepatic function within 90 days prior to registration
Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards
Definitive clinical or radiologic evidence of metastatic disease
Pathologically positive lymph nodes or nodes > 1.5 cm short axis on CT or MR imaging
Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy for any reason
Prior systemic therapy for prostate cancer; note that prior therapy for a different cancer is allowable
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.
22-124 Main-CAV
To evaluate the effect of cabozantinib in combination with avelumab on OS compared to avelumab alone in patients with mUC who did not progress during first-line platinum-based chemotherapy therapy, i.e. patients who had CR, PR or SD after completion of first line platinum-based chemotherapy.
Patients will be expected to come to all clinic appointments, have labs drawn on the first day of every cycle, take medications as prescribed, return all empty pill bottles and diary, and call the clinic with questions.
Prior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy (platinum-based chemotherapy; gemcitabine-cisplatin, gemcitabine-carboplatin, MVAC or ddMVAC).
No prior immunotherapy with IL-2, IFN-α, or an anti-PD-1, anti-PD-L1, anti-PDL2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
ECOG Performance Status of 0 or 1
Age ≥ 18 years
No known symptomatic central nervous system (CNS) metastases.
No major surgery within 4 weeks prior to randomization.
No palliative radiotherapy within 48 hours prior to patient randomization.
No known cavitating pulmonary lesion(s) or known endobronchial disease manifestation.
PSCI 21-026 A Phase III Randomized, Open-Label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab in Combination With Tremelimumab and Enfortumab Vedotin or Durvalumab in Combination With Enfortumab Vedotin for Perioperative Treatment in Patients Ineligible for CisplatinUndergoing Radical Cystectomy for Muscle Invasive Bladder Cancer(VOLGA)
A clinical trial for adults with Muscle Invasive Bladder Cancer. The study is looking at alternative treatments for those persons who cannot tolerate certain forms of chemotherapy.
This protocol contains two portions. The safety run in (SRI) and the main portion of the trial. The SRI will take place over three cycles of treatment prior to having cystectomy or 9 cycles if you have had a previous cystectomy. The main study will have the same schedule of activities. The only difference between the two is the SRI will look at how safe the drug combinations are and the main trial will look at how effective they are on treating muscle invasive bladder cancer.,
body weight above 30kg/66 pounds
history or an organ transplant
inflammatory bowel disease
PSCI 21-038 Phase Ib Study of Brigatinib Plus Bevacizumab in Patients with ALK-rearranged Non-Small Cell Lung Cancer (NSCLC)
Clinical trial on the treatment of persons who are diagnosed with Lung Cancer.
Participants in this study will undergo screening tests and procedures to determine whether you are eligible to participate with the research study. If you meet the requirements to participate with the study, you be given Brigatinib by mouth each day for 7 days. If you do not experience any intolerable side effects while taking Brigatinib, you will receive an increased dose starting on Day 8 and take Brigatinib continuously each day thereafter. Bevacizumab will be given intravenously (IV) on Day 8 in combination with Brigatinib. The first 28 days of treatment is called Cycle 1. Starting Cycle 2 and thereafter, one cycle will consist of 21 days. Bevacizumab will be given on Day 1 every 21 days starting Cycle 2. Participation is expected to last until your disease worsens or you decide you no longer want to participate in the study. There will be a follow-up visit within 30 days of treatment discontinuation. The study team will check in with you every three months after this final visit to see how you are doing.If you decide to take part, this is what will happen: Since we are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have Anaplastic Lymphoma Kinase (ALK) Rearranged Non-Small Cell Lung Cancer (NSCLS), not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they have tolerated their doses. If you take part in this research study, you will be given a drug diary. You will be asked to document information in the drug diary about the study drug you are being asked to take.If you take part in this research, study you will be given a study calendar. Information about what to expect during and between study visits will be included in the study calendar.
major surgery in the last 30 days
heart attack or stroke in the last 6 months
A Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early-Stage, P16 Positive Oropharyngeal Cancer (NRG-HN005) (PSCI# 20-011)
The purpose of the first part of this study is to compare the usual treatment of a standard-dose radiation given over 6 weeks with cisplatin chemotherapy to a reduced-dose radiation given over either 6 weeks with cisplatin or 5 weeks with the immunotherapy drug, nivolumab. A lower dose of radiation as compared to the usual radiation treatment dose could be as effective in lengthening the time without your cancer getting worse. Nivolumab with reduced-dose radiation may or may not be as effective in lengthening the time without your cancer getting worse. This study will help the study doctors find out if this different approach is the same or worse than the usual approach.
The purpose of the first part of this study is to compare the usual treatment of a standard-dose radiation given over 6 weeks with cisplatin chemotherapy to a reduced-dose radiation given over either 6 weeks with cisplatin or 5 weeks with the immunotherapy drug, nivolumab. A lower dose of radiation as compared to the usual radiation treatment dose could be as effective in lengthening the time without your cancer getting worse. Nivolumab with reduced-dose radiation may or may not be as effective in lengthening the time without your cancer getting worse.This study will help the study doctors find out if this different approach is the same or worse than the usual approach.
Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations
P16-positive based on local site immunohistochemical tissue staining
Zubrod Performance Status of 0-1 within 14 days prior to registration
Only English, Spanish, or French speaking patients are eligible to participate as these are the only languages for which the mandatory dysphagia-related patient reported instrument (MDADI) is available
Recurrent disease
Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles
Cancers considered to be from an oral cavity site or the nasopharynx, hypopharynx, or larynx, even if p16-positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas
Carcinoma of the neck of unknown primary site origin (T0 is ineligible, even if p16-positive)
GLNE 007 Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
The purpose of this study is to see if stool or blood can be used to determine whether or not a patient has any colon polyps or colon cancer. This study will compare these biological samples (blood, urine, stool) to any colonoscopy or surgery a patient has to see if the outcome could be predicted.
Subjects with Colon Cancer or Adenoma
OR subjects undergoing colonoscopy screening
HIV/Hepatitis
Have had or are receiving chemotherapy or radiation
Have had surgery for your colon cancer
Cognitive Impairment
BCC016: DFMO for Medullo
This is a study of the drug DFMO (difluoromethylornithine) for medulloblastoma that has returned or not responded to treatment. 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.
You will have exams, tests, and procedures while on the study to evaluate whether you can participate in the study and how you are doing while on the study. These include physical exams, blood tests, urine tests, bone marrow aspirate and biopsies, heart tests, hearing tests, and imaging evaluations such as MRI of your brain and spine. You will receive treatment on this study for a total of about 2 years. After treatment, you will have follow-up examinations and medical tests. We would like to continue to find out about your health for about 5 years after you complete the study.
You are 21 years old or younger
You must have no evidence of disease at this time
NMTRC006B: 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
PSCI 22-127 NRG-BN012: A RANDOMIZED PHASE III TRIAL OF PRE-OPERATIVE COMPARED TO POST-OPERATIVE STEREOTACTIC RADIOSURGERY IN PATIENTS WITH RESECTABLE BRAIN METASTASES
Individuals with cancer that has spread to their brain who have 1-4 lesions, or breast cancer history and may or may not have treatment and are within 8 weeks of surgery, will be randomized to either surgery first followed by radiation or radiation first followed by surgery.
Subjects are expected to come to all Radiation/Gamma Knife appointments and continue onto surgery/resection.
Known active or history of invasive non-CNSprimary cancer based on documented pathologic diagnosis within the past 3 years.
All brain metastases must be located ≥ 5 mm from the optic chiasm and outside the brainstem.
Lesions chosen for surgical therapy must be deemed appropriate targets for safe, gross total resection by the treating surgeon
Age ≥ 18
Evidence of leptomeningeal disease
Primary histology of germ cell tumor, small cell carcinoma or lymphoma
Inability to undergo MRI with contrast.
More than one brain metastasis planned for resection
PSCI 22-082 Tropion-Breast03
This is an investigational drug study comparing the Investigational treatment with treatments called capecitabine and pembrolizumab as stand-alone treatment agents or in combination. Study participants will be required to attend all study visits, complete the tests and procedures, receive study treatment, and complete questionnaires.
Participants must attend all visits, receive study treatment, have blood drawn, complete questionnaires, have imaging scans done (ECG, ECHO or MUGA, CT, mammogram or breast MRI), keep a diary, have an eye exam, and provide a tumor sample.
Histologically confirmed invasive TNBC.
Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy.
Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab.14
No evidence of locoregional or distant relapse. Radiological scans before treatment are not required and should be obtained as per local institutional practice.
History of prior invasive breast cancer, or evidence of recurrent disease following preoperative therapy and surgery.
As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including history of allogeneic organ transplant and active bleeding diseases, ongoing or active infection,
History of another primary malignancy except for adequately resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ disease that has undergone potentially curative therapy
Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
Return to Work Survey Development for Breast Cancer Survivors
The purpose of this study is to develop and test a survey to gain information that will improve our understanding of the return to work experience for breast cancer survivors. Study participants will answer questions on a questionnaire and undergo a one-on-one interview about those questions to ensure the wording and content is appropriate.
This is a questionnaire development study. Participants will be asked to complete a series of questions on a questionnaire form. Next, participants will sit for a one-on-one interview to discuss the questions and answer choices on the questionnaire.
Last cancer treatment was 2-5 years ago
Received breast cancer treatment at Penn State Health
Employed outside the home at least part time (>20hr/wk) before and after cancer treatment
Underwent prophylactic treatment due to increased risk, such as testing positive for BRCA gene (breast cancer)
Unemployed or does not participate in the workforce for pay either before or after cancer
Currently being treated for any type of cancer
Has experienced a work-related injury that does not allow work, is receiving Worker's Compensation, or is currently in litigation for work-related injury
22-111 A Phase 1/2 Open-label Study to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of Modakafusp Alfa (TAK-573) as a Single Agent in Patients With Relapsed Refractory Multiple Myeloma
This study involved testing a drug for the treatment of relapsed/refractory multiple myeloma. The trial consists of three parts: the first part looks at the safety of the drug when given to patients; the second and third part looks the dose of the drug at how the drug is used through the body and how it acts on multiple myeloma.
Participants will need to attend the scheduled visits, provide medical history, blood samples, complete questionnaires, radiology exams, bone marrow aspirate and/or biopsy, and take study medication
Aged 18 years or older.
For patients in Parts 2 and 3 only: Measurable disease defined as one of the following: a)Serum M-protein ≥500 mg/dL (≥5 g/L).
During Part 1 only, patients not meeting the above criteria for measurable disease should, at least, have measurable bone marrow plasmacytosis (≥10%) and/or plasmacytoma (≥1 cm in diameter) detected by physical examination or imaging.
ECOG performance status of ≤2.
Patients who have received autologous SCT 60 days before first infusion of modakafusp alfa or patients who have received allogeneic SCT 6 months before first infusion.
Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
Part 1: Until the MTD/OBD is defined, patients who have received daratumumab (or other investigational anti-CD38 antibody) for at least 5 months (steady state) require a 90-day wash-out period before receiving modakafusp alfa.
Patient has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade ≤1 or baseline,
A Randomized Phase II Trial of Adjuvant Pembrolizumab versus Observation Following Curative Resectionfor Stage I Non-small Cell Lung Cancer (NSCLC) with Primary Tumors Between 1-4 cm:Big Ten Cancer Research Consortium BTCRC-LUN18-153 (PSCI# 20-043)
This is a research study to find out if giving a drug called pembrolizumab after lung cancer surgery does a better job at keeping the cancer from coming back than surgery alone. The usual approach for patients who are not in a study is to be followed closely by their doctor to watch in case the cancer returns. Participants in this study will be assigned by chance (flip of a coin) to be watched closely by their doctor or to receive a drug called pembrolizumab. Pembrolizumab is given as an infusion inthe clinic once every six weeks. . You will have tests, exams and procedures that are part of your regular care and for study purposes. You will have scans every 12 weeks to make sure the cancer hasn’t come back. If you are assigned to receive pembrolizumab, you can continue to receive it for up to 1 year.
If you decide to take part in this study, you will be assigned to one of two groups. This is called randomization. A computer will assign you to a group in the study by chance. This is done by chance because no one knows if one study group is better or worse than the other. You will have an equal chance (50/50) of being assigned to either group.
Patients must have undergone complete surgical resection of their stage I non-small cell lung cancer between 4-12 weeks prior to registration.
Pathological tumor size must be 1.0 – 4.0 cm in size.
ECOG Performance Score 0-1
Baseline CT chest must be performed within 28 days of randomization
No prior PD-1 or PD-L1 inhibitors are permitted.
No prior neo-adjuvant or adjuvant chemotherapy is permitted for this lung cancer.
Patients with a history of (non-infectious) pneumonitis that required steroids
Has active autoimmune disease that has required systemic treatment in the past 2 years.
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)
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.
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
A Phase 1/2, Open-label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects with Advanced or Metastatic Malignancies Harboring ALK, ROS1, or NTRK1-3 Alterations (CARE)
Repotrectinib for cancer that has returned or is not responding to treatment
If you agree to take part in this study, you will need to visit the study site regularly and follow the study procedures listed later in this document. You will be told what these procedures are and why they are needed. These procedures include interviews, exams, heart testing, tumor assessments, and blood and urine samples. You will be asked to take the study drug Repotrectinib. This is a capsule to be taken orally.
You are positive for certain changes in your genes which we will test you for as needed
A011801 THE COMPASSHER2 TRIALS (COMPREHENSIVE USE OF PATHOLOGIC RESPONSE ASSESSMENT TO OPTIMIZE THERAPY IN HER2-POSITIVE BREAST CANCER): COMPASSHER2 RESIDUAL DISEASE (RD), A DOUBLE-BLINDED, PHASE III RANDOMIZED TRIAL OF T-DM1 AND PLACEBO COMPARED WITH T-DM1 AND TUCATINIB (PSCI# 21-155)
The purpose of this study is to compare the usual treatment with T-DM1 alone to T-DM1 plus tucatinib. The addition of tucatinib to the usual treatment could prevent the breast cancer from returning
The purpose of this study is to compare the usual treatment with T-DM1 alone to T-DM1 plus tucatinib. The addition of tucatinib to the usual treatment could prevent the breast cancer from returning.
ECOG Performance Status 0-1
Patients must have received neoadjuvant chemotherapy with one of the following regimens: THP, TMP, AC-TH(P); TCH(P); FAC-TH(P), or FEC-TH(P).
HER2-positive breast cancer per pathology
Prior treatment must have consisted = 6 cycles of chemotherapy and HER2-directed therapy, with a total duration of = 12 weeks, including at least 9 weeks of preoperative taxane and trastuzumab with or without pertuzumab (or FDA-approved biosimilars).
Patients with known active and/or untreated Hepatitis B or Hepatitis C or chronic liver disease are ineligible.
Stage IV (metastatic) breast cancer
History of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration
Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report
Phase 1/2 Study to Evaluate Palbociclib (IBRANCE®) in Combination with Irinotecan and Temozolomide or in Combination with Topotecan and Cyclophosphamide in Pediatric Patients with Recurrent or Refractory Solid Tumors
A study of the safety of palbociclib with irinotecan and temozolomide and palbociclib with topotecan and cyclophosphamide for children with solid tumors that returned or did not respond to previous treatment.
If you join the study, you will be assigned to receive either palbociclib in combination with backbone chemotherapy of IRN and TMZ or the backbone chemotherapy (IRN and TMZ). You may be asked to provide biological samples (such as blood or urine or tumor tissue sample) 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 be required to visit the study doctor on days 1 to 5 of each 21-day cycle and on day 14 for the first 2 cycles to undergo study assessments and to provide information about your health.
Ages ≥2 and <21
Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial
To assess whether the addition of 6 cycles of cabazitaxel to abiraterone acetate in patients with CRPC that have previously received docetaxel and ADT for HSPC can improve PFS compared toabiraterone acetate alone.
To assess whether the addition of 6 cycles of cabazitaxel toabiraterone acetate in patients with CRPC that have previouslyreceived docetaxel and ADT for HSPC can improve PFS compared toabiraterone acetate alone.
Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate).
Previous chemotherapy with at least 3 cycles of docetaxel for hormone-sensitive metastatic prostate cancer.
Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (CT/MRI of abdomen/pelvis, bone scintigraphy or NaF PET/CT).
Ability to swallow abiraterone acetate tablets as a whole.
Pure small cell or other variant (non-adenocarcinoma) prostate cancer histology for which treatment with abiraterone would not be considered appropriate.
Patients may not be receiving other therapeutic investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy.
Any medical condition for which prednisone (corticosteroid) is contraindicated.
Active infection requiring treatment with antibiotics.
20-099, EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response
The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.
The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.
Patents must have a left ventricular ejection fraction (LVEF) within normal institutional parameters (or > 50%).
Patient must not have Stage IV (metastatic) breast cancer
Patient must not have T4 and/or N3 disease, including inflammatory breast cancer.
Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
Patient must not have a concurrent serious medical condition that would preclude completion of study therapy.
ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED)
Upper tract urothelial cancer (UTUC) is a recurrent disease. The current standard treatment for most UTUC patients requires surgery either removing some of the ureter in each operation or radical nephroureterectomy (RNU-removal of kidney and ureter) but the role of minimally invasive & kidney- preserving methods is increasing. The use of TOOKAD (padeliporfin) was investigated in a Phase 1 clinical study in the minimally-invasive treatment of UTUC with the goal of identifying safe laser/light exposure and signs that the tumor has been reduced or eliminated. Early results from this study have been highly promising, revealing the effects of tumor removal with a positive safety profile, indicating the potential role of TOOKAD (padeliporfin) in the treatment of low-grade UTUC disease.This Phase 3 study is designed to provide confirmation of the observed Phase 1 findings. Patients are expected to remain in the study for 25 to 28 months. Participation in this study will include up to 9 study visits to Hershey Medical Center and 2 phone visits.
There are 4 stages to this study: screening phase, induction study treatment phase, maintenance study treatment phase and long-term follow-up phase.In screening you can expect to be asked questions about your medical history, MRI or CTU, blood and urine samples, physical exam, vitals, tumor assessment by ureteroscopy and biopsy under anesthesia.Induction Treatment Phase (1-3 months)•Participants undergo anesthesia and receive the study therapy 1 to 3 times, about 4 weeks apart. If a participant does not achieve Complete Response (CR)* after 3 treatments (or if their disease has progressed as defined in the protocol), the participant will be discontinued from the Treatment Phases and enter the Long-term Follow-up Phase.Maintenance Treatment Phase (12 months)•Participants who achieve CR* from Induction Treatment Phase will be followed for 12 months. Up to 3 repeated study therapy doses will be provided for participants who have treatable tumor recurrence as determined by the study doctor.Long-term Follow-up Phase (48 months)•Patients who achieve CR and then enter the maintenance treatment phase and who have a CR after the end of maintenance treatment phase will enter the Long-term Follow-up Phase and will be followed up for up to an additional 48 months in the Long-term Follow-up Phase or until recurrence, progression, death or loss to follow up, to document safety and ongoing response.•Patients discontinued from the treatment phases and who have received at least one study treatment will be followed up for additional 12 months in the long-term follow-up phase of the study from last VTP treatment.
Biopsy-proven disease. A concurrence of the central pathology reader will be required for eligibility.
Up to 2 biopsy-proven sites of low-grade involvement. Please contact site for tumor dimension criteria.
Karnofsky Performance Status ≥ 50%
Adequate organ function defined by baseline Lab testing
Carcinoma in situ (CIS) current or previous in the upper urinary tract
History of invasive T2 or higher urothelial cancer in past 2 years
Participation in another clinical study involving an investigational product within 1 month before study entry
BCG or local chemotherapy treatment in the upper urinary tract within 2 months prior to inclusion
Phase III Study of Daratumumab/RHuPH20 + Lenalidomide or Lenalidomide in Patients with Multiple Myeloma Using MRD to Direct Therapy Duration (PSCI# 19-079) (S1803)
This study is being done to answer the following questions: 1.Will adding the drug daratumumab/rHuPH20 to the usual maintenance treatment with lenalidomide after stem cell transplant help multiple myeloma patients survive longer?2.For patients who have no evidence of multiple myeloma in their bone marrow (patients who do not have “minimum residual disease” [MRD-negative]), should maintenance therapy be stopped after 2 years? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.
Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration
Patients with disease measurable by serum light chain assay alone are eligible (defined as ≥ 100 mg/L on involved light chain).
Patients must be ≥ 18 and ≤ 75 years of age at time of registration to Step 1.
Patients must have history and physical exam within 28 days prior to registration.
Patients must have Zubrod Performance Status ≤ 2.
Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
Patients must not have progressive disease at any time prior to registration.
Patients must not be refractory or intolerant to either lenalidomide or daratumumab/rHuPH20.
Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
PSCI# 23-137 NRGF-001: ACTIVITY MONITORING TO IMPROVE PATIENT CARE DURING CHEMORADIOTHERAPY FOR LOCALLY ADVANCED NON-SMALL CELL LUNG CANCER (LA-NSCLC)
this trial looks at the difference in health between lung cancer subjects who do deliberate exercise measured by a fit bit and those who do not.
Participants will need to commit to all appointments. All those assigned to the fit bit arm must agree to wear it as instructed. You will wear the activity monitor for approximately 4 months. There are approximately 13 visits in total that you would need to come to the clinic.
Planned initiation (within the 30 days after study registration) of fractionated (≥15 treatments) thoracic radiotherapy with concurrent chemotherapy.
Age ≥ 18
Ambulates independently or with a cane (use of a walker not permitted)
Patients receiving concurrent treatment for another cancer that is expected to affect the toxicity profile of thoracic chemoradiotherapy
A Phase Ib/II Study of Venetoclax (ABT-199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia (EA9152) (PSCI 18-047)
This study is being done to determine what effects (good and bad) the therapy venetoclax has on your type of cancer (acute lymphoblastic leukemia, also known as ALL). This investigational therapy will be added to what is a standard, liposomal vincristine, to treat relapsed acute lymphoblastic leukemia. It is hoped that venetoclax will help liposomal vincristine work better to kill your ALL, but it has not yet been proven.
venetoclax will be given orally in a tablet formulation once daily in 3 dose arms with a fixed, standard dose of intravenous (IV) liposomal vincristine 2.25mg/m2 weekly starting after a 2 week lead-in phase of venetoclax
ECOG performance status 0-2
Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent
Adequate liver function with AST/ALT less than 3X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent
Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent
Evidence of isolated extramedullary relapse (i.e., testicular or CNS)
Serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled
Poorly controlled HIV, or CD4 < 400. HIV positive patients are allowed on this study if they have a CD4 count greater than or equal to 400, and are on a stable antiviral regimen
Patients with NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled