NCT00871481

Laboratory-Treated T Cells and Ipilimumab in Treating Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Recurrent Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	ipilimumab	Given IV
DRUG	cyclophosphamide	Given IV
PROCEDURE	biopsy	Optional correlative studies
BIOLOGICAL	aldesleukin	Given SC
OTHER	immunohistochemistry staining method	Correlative studies
GENETIC	polymerase chain reaction	Correlative studies
OTHER	immunoenzyme technique	Correlative studies
BIOLOGICAL	therapeutic cytotoxic T lymphocytes	Given IV

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2009-03-30
• Last updated: 2017-04-19

Locations

1 site across 1 country: United States