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Clinical Trial DRUG CA-ALT-801-01-10

Title
A Phase Ib/II Trial of ALT-801 in Combination with Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer
Principal Investigator
Timothy Kuzel
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.DRUG CA-ALT-801-01-10
Purpose
The purpose of this research study is to find out what are the side effects of the study drugs, ALT-801 plus cisplatin and gemcitabine, in patients with bladder cancer.
Overview
Participants in this study have been diagnosed with a type of aggressive bladder, renal pelvis, ureters or urethra cancer that has grown or spread and cannot be cured by surgery, radiation or any other conventional therapies. ALT-801 is an investigational drug, which means that it has not been approved by the United States Food and Drug Administration (FDA). ALT-801 is a fusion protein, which means that it is made by connecting together pieces of two proteins, which are substances normally found in the cells. One piece is a protein called a T cell receptor, or TCR, which is found on the immune cells and helps them to recognize cancer cells and cells infected with viruses. The TCR is connected to a piece of a substance called interleukin-2 (IL-2). IL-2 is a protein made by certain white blood cells that helps to fight infection and to kill cancer cells. The ALT-801 study drug combines a piece of IL-2 connected to the TCR which helps direct the IL-2 to the tumor. It is hoped that directing IL-2 to the tumor will decrease the amount of IL-2 needed to shrink the tumor. ALT-801 will be administered in combination with cisplatin and gemcitabine. Cisplatin and gemcitabine treatment may allow ALT-801 to recognize cancer cells more effectively.
Eligibility
Some of the eligibility criteria include:
  • Participants must have sufficient heart, lung, liver, kidney and other major organ functions.
  • Participants have been diagnosed with muscle invasive or metastatic urothelial cancer of bladder, ureters, renal pelvis, and urethra.
  • Participants must be at least 18 years of age.
  • Participants can have no radiotherapy, other chemotherapy, other immunotherapy, or other investigational therapy at the same times as study.
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 in this study will have up to three courses of study treatment in the initial treatment period and up to 4 additional weekly doses of study drug (ALT-801) in the repeat treatment period. Each course of initial study treatment consists of cisplatin (Day 1), gemcitabine (Days1 and 8), ALT-801 (Days 3, 5, 8 and 10), and a rest period (Days 11-21). After this time, if scans show the disease has responded to the treatment, participants will be eligible to receive four additional weekly doses of study drug (ALT-801) treatment. During this period, participants will not receive cisplatin and gemcitabine.
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: 21-Dec-14 11:36 PM

 

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