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Clinical Trial DRUG 0761-009

Title
Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 or Investigator’s Choice in Subjects with Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)
Principal Investigator
Adam M Petrich
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.DRUG 0761-009
Purpose
The main purpose of this study is to determine if KW-0761, an investigational drug (has not been approved by the U.S. food and Drug Administration [FDA]), will work against adult T-cell leukemia-lymphoma (ATL)that has failed to respond to other treatments, and to evaluate its side effects.
Overview
Antibodies are proteins which the immune system, your body’s defense system, uses to recognize foreign or unwanted material, such as infection or some cancers. Antibodies are used to try to destroy cancer cells while causing little harm to normal cells. The cancer cells of many patients with T-cell leukemia-lymphoma contain a protein called CCR4. KW-0761 is an antibody that finds T-cells that have a protein called CCR4 on their surface and attempts to destroy them.
Eligibility
Some of the eligibility criteria include:
  • Participants must be 18 years of age or older.
  • Participants must have relapsed(cancer returned) or refractory(cancer did not respond to treatment)adult T-cell Leukemia Lymphoma (ATL)after at least one systemic (whole body) therapy regimen (cycle).
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participants will be assigned by chance (like flipping a coin) using a computer program into one of two groups. One group identified as the Investigator's choice group will receive one of 3 treatments that the doctor decides would best treat the participant's cancer. The choices are pralatrexate (also known as Folotyn; this drug is currently only available in the US), gemcitabine and oxaliplatin (also known as GemOx) or a 3 drug regimen known as DHAP(dexamethasone, cisplatin and cytarabine). The other group referred to as the KW-0761 group will receive the study drug. All of the treatments will be given by infusion (into a vein)and dependent upon what drug a participant is receiving, a cycle (one treatment course) can be anywhere from 4 to 22 days. Participants will continue receiving treatment as long as their cancer responds to the treatment or until the doctor feels it is in their best interest to stop.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 22-Sep-14 07:12 AM

 

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