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This phase I/II trial is studying the side effects of giving laboratory-treated T cells and ipilimumab together to see how well they work in treating patients with metastatic melanoma. Treating a patient's T cells in the laboratory may help the T cells kill more tumor cells when they are put back in the body. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving laboratory-treated T cells together with ipilimumab may kill more tumor cells
PRIMARY OBJECTIVES: I. Evaluate the safety and efficacy of adoptively transferred cytotoxic lymphocytes (CTL) targeting melanoma tumors combined with anti-CTLA4. II. Evaluate the influence of anti-CTLA4 (ipilimumab) on the duration of in vivo persistence and anti-tumor efficacy achieved following adoptive transfer of antigen-specific CTL. SECONDARY OBJECTIVES: I. Evaluate the influence of anti-CTLA4 on the induction of T cells to non-targeted tumor-associated antigens (antigen-spreading) following adoptive transfer antigen-specific CTL, and the correlation of these responses with clinical outcome. OUTLINE: Patients receive cyclophosphamide intravenously (IV) on day -2, therapeutic cytotoxic T lymphocytes IV over 30-60 minutes on day 0, low-dose aldesleukin subcutaneously (SC) twice daily (BID) on days 0-13, and ipilimumab IV over 90 minutes on days 1, 22, 43, and 64 in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Start Date
February 1, 2009
Primary Completion Date
September 1, 2013
Completion Date
October 1, 2013
Last Updated
April 19, 2017
10
ACTUAL participants
ipilimumab
BIOLOGICAL
cyclophosphamide
DRUG
biopsy
PROCEDURE
aldesleukin
BIOLOGICAL
immunohistochemistry staining method
OTHER
polymerase chain reaction
GENETIC
immunoenzyme technique
OTHER
therapeutic cytotoxic T lymphocytes
BIOLOGICAL
Lead Sponsor
Fred Hutchinson Cancer Center
Collaborators
NCT00937937
NCT01303341
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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