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Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis 2

Principal Investigator:

Meghna S Trivedi, MD

Contact Number:

212-342-5162

NCT Number:

NCT01042379

Population:

Adult

Phase:

II

The primary purpose of this trial is to determine whether adding new drugs to the standard initial cancer treatments for breast cancer increases the probability there there will be no residual disease (cancer cells left after many attempts to remove the cancer), compared to the initial cancer treatment alone. The intervention includes different drugs to determine which study drugs might result in better outcomes than standard treatment. Are you Eligible? (Inclusion Criteria) To be eligible for this trial patients must: have breast cancer and cannot already have had chemotherapy. be at least...
Locoregional breast cancer recurrence following targeted intraoperative radiotherapy (IORT) for ductal carcinoma in situ (DCIS)

Principal Investigator:

Eileen Patricia Connolly, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT03216421

Population:

Adult

Phase:

II

The purpose of this study is to examine whether targeted Intraoperative Radiotherapy (IORT) is as effective as external beam radiation in treating DCIS and preventing it from returning. In addition, we will evaluate the side effects of IORT (toxicity), imaging changes, cosmetic appearance of the breast and your quality of life. In this study, subjects with DCIS will have IORT during with breast conserving surgery. Follow-up duration is 5 years. Are you Eligible? (Inclusion Criteria) To be eligible for this trial, patients must be: Female 18 years old or older with DCIS suitable for breast...
Long-Term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated with Gene-Modified Cells

Principal Investigator:

Ran Reshef, MD, MSc

Contact Number:

212-342-5162

NCT Number:

NCT05041309

Population:

Adult

Phase:

II

The purpose of this study is to monitor you for any delayed side effects that may possibly be related to the experimental gene-modified therapy product you received in the Kite-sponsored study for Axicabtagene ciloleucel (“axi-cel”). The main study does not involve treatment. In the re-treatment portion, you will be provided access to a second course of treatment with lymphodepleting chemotherapy and axi-cel. Axi-cel is manufactured using your own blood cells. If you meet the requirements for the retreatment part of this study, the study doctor will confirm if leftover product...
NAUTIKA1: A MULTICENTER, PHASE II, NEOADJUVANT AND ADJUVANT STUDY OF MULTIPLE THERAPIES IN BIOMARKER-SELECTED PATIENTS WITH RESECTABLE STAGES IBIII NON-SMALL CELL LUNG CANCER

Principal Investigator:

Catherine Ann Shu, MD

Contact Number:

212-342-5162

NCT Number:

NCT04302025

Population:

Adult

Phase:

II

The purpose of this study is to evaluate the safety and efficacy of different experimental targeted cancer therapies (not approved by the FDA for treatment of your type of cancer) in patients who have stage IA2, IB, II, IIA or selected IIIB non-small cell lung cancer tumors that are untreated and able to be removed by surgery. The treatments that will be investigated are the study-drugs alectinib, entrectinib, and vemurafenib plus cobimetinib. Based off of individual molecular abnormalities, each participant will be assigned to either the alectinib, entrectinib, or vemurafenib plus...
Open Label Phase II Trial of Cabozantinib in Patients withMetastatic Castrate Resistant Prostate Cancer (mCRPC) andKnown Amplifications or Activating Mutations in Gene Targets of Cabozantinib who have Received Prior Anti Androgen Therapy

Principal Investigator:

Mark N. Stein, MD

Contact Number:

212-342-5162

NCT Number:

NCT04631744

Population:

Adult

Phase:

II

The purpose of this study is to determine what effects (good and bad) cabozantinib has in treatment of prostate cancer. Cabozantinib (Cometriq™, Cabometyx™) is an oral medication that blocks activity of specific proteins in the body. It is approved by the Food and Drug Administration (FDA) for use in patients with medullary thyroid carcinoma and advanced renal cell carcinoma but is not approved to treat prostate cancer. Are you Eligible? (Inclusion Criteria) Age >18 years. Evidence of metastatic Prostate Cancer on imaging (bone scan and/or CT/MRI scan) • Previously...
Phase II Trial of Surgical Resection and Heated Intraperitoneal Peritoneal Chemotherapy (HIPEC) for Adrenocortical Carcinoma

Principal Investigator:

Michael David Kluger, MD

Contact Number:

212-342-5162

NCT Number:

NCT03127774

Population:

Adult

Phase:

II

motherapy can improve survival in patients with metastatic adrenal cortical carcinoma. Are you Eligible? (Inclusion Criteria) * Histologically proven ACC with the majority of disease confined to the peritoneal cavity and resectable; or disease that in the opinion of the investigators can be managed medically or surgically and does not present an immediate threat to the patientâs life. * Disease evaluable by CT or PET imaging * All disease should be deemed resectable based on imaging studies e.g.: - Hepatic metastases (unilateral or bilateral â¤5 lesions, â¤...
Phase II, Neoadjuvant study of parasympathetic stimulation with bethanechol in combination with gemcitabine and nab-paclitaxel in borderline resectable pancreatic adenocarcinoma

Principal Investigator:

Susan E. Bates, MD

Contact Number:

212-342-5162

NCT Number:

NCT05241249

Population:

Adult

Phase:

II

of this study is to determine whether the drug, bethanechol, could potentially be used in combination with chemotherapy regimen gemcitabine and nab-paclitaxel and surgery to decrease the chance of the cancer coming back after it is removed. Animal models have shown that treatment with bethanechol can inhibit cancer growth and spread. The chemotherapy regimen nab-paclitaxel for use in combination with gemcitabine to treat patients with metastatic pancreatic cancer is FDA approved. Although bethanechol is FDA approved, in this study its use is experimental. The aim of the study is to show that...
Phase II study of Polatuzumab vedotin in combination with chemotherapy in subjects with Richter's Transformation

Principal Investigator:

Andrew H Lipsky, MD

Contact Number:

212-342-5162

NCT Number:

NCT04679012

Population:

Adult

Phase:

II

This research is being done because Richter’s transformation, which is a life- threatening complication of chronic lymphocytic lymphoma (CLL), and is associated with poor overall survival rate. The study drug administration is a combination of the investigational drug, Polatuzumab vedotin, in combination with Rituximab, Etoposide, Prednisone, Cyclophosphamide, and Hydroxydaunorubicin, also referred to as PolaR-EPCH. An investigational drug means it has not been approved by the FDA or any other international regulatory agencies. The purpose of this study is to find out what effects the...
Pembrolizumab in combination with gemcitabine for previously treated mycosis fungoides and Sezary syndrome: efficacy and characterization of immune response

Principal Investigator:

Larisa J. Geskin, MD

Contact Number:

212-342-5162

NCT Number:

NCT04960618

Population:

Adult

Phase:

II

Primary objective: Determine preliminary clinical effectiveness of pembrolizumab plus gemcitabine in previously treated MF and SS with overall response rate (ORR) using the composite global response criteria including: radiological imaging (PET/CT scans), flow cytometry and mSWAT assessments. 2. Secondary objectives: a. To estimate duration of response (DOR) of pembrolizumab plus gemcitabine in previously treated MF and SS. b. To estimate progression-free survival (PFS) pembrolizumab plus gemcitabine in previously treated MF and SS. c. To estimate overall survival (OS) of patients with...
Phase II single arm study testing SBRT, Adenosine signaling Modulation (AB680, AB928), and Immune Checkpoint inhibition (AB122) for men with hormone sensitive Oligometastatic prostate cancer (SBRT-AMICO)

Principal Investigator:

Catherine S Spina, MD, PhD

Contact Number:

212-342-5162

NCT Number:

NCT05915442

Population:

Adult

Phase:

II

This study aims to test the safety and effectiveness of zimberelimab, etrumadenant, and quemliclustat when given together with radiotherapy as a potential treatment to hormone sensitive oligometastatic (cancer that has spread to other areas of the body) prostate cancer. Zimberelimab, etrumadenant, and quemliclustat are considered immunotherapy drugs. These type of drug works by blocking a protein that can cause tumors to grow. By blocking this protein, the study drugs may cause your cancer to stop growing or to shrink. These study drugs are not approved by Health Authorities including the...

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