Clinical Trial DRUG CA-ALT-801-01-10
- 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
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CA-ALT-801-01-10
- 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.
- 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.
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.
- 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.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 09-Oct-15 01:42 AM
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