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: Accepting New Patients
- 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
Find Related Clinical Trials
Browse by Disease Sites
Other Clinical Trials by Timothy Kuzel
- Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (mogamulizumab) Versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma
- A Randomized, Open-Label, Phase 3 Trial of brentuximab vedotin (SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma
- A Phase 1 Open-label Study of Safety and Tolerability of MEDI4736 in Subjects with Metastatic or Unresectable Melanoma in Combination with Dabrafenib and Trametinib or with Trametinib Alone
- A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects with Metastatic Renal Cell Carcinoma that has Progressed after Prior VEGFR Tyrosine Kinase Inhibitor Therapy
- A Randomized Phase II Trial of Sunitinib/Gemcitabine or Sunitinib in Advanced Renal Cell Carcinoma with Sarcomatoid Features
- A Phase II Trial of Dasatinib in Patients with Unresectable Locally Advanced or Stage IV Mucosal, Acral and Solar Melanomas
- Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients with Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy
- A Randomized Phase II Study of Ipilimumab at 3 mg/kg or 10 mg/kg Alone or in Combination with High Dose Interferon-a in Advanced Melanoma
- A Randomized Phase II Trial of Ipilimumab with or without Bevacizumab in Patients with Unresectable Stage III or Stage IV Melanoma
- A Randomized Phase II Study of Sequential Biotherapy with Aflibercept and High Dose IL-2 versus High Dose IL-2 alone in Patients with Inoperable Stage III or Stage IV Melanoma: Efficacy and Biomarker Study
- A Randomized Phase I Dose-Escalation Trial of Carfilzomib with and without Romidepsin in Cutaneous T-Cell Lymphoma
- Phase II Trial of Everolimus or Everolimus plus Paclitaxel as First-line Therapy in Cisplatin-ineligible Patients with Advanced Urothelial Carcinoma (GU10-147)
last updated: 05-Jul-15 01:02 AM
Clinical trial availability changes frequently. Please check this site often for updates or call 312.695.1102 for personal assistance.