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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT00871481
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Recurrent Melanoma
  • Stage IV Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Feb 28, 2009
Status verified
Apr 2017
Primary completion
Sep 30, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (laboratory-treated T cells and ipilimumab)
    Patients receive cyclophosphamide IV on day -2, therapeutic cytotoxic T lymphocytes IV over 30-60 minutes on day 0, low-dose aldesleukin SC 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.

Primary Outcome Measure

Numeric frequency and functional persistence of transferred CTL [ Time Frame: Up to 6 months post-infusion ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattleWashington98109-

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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium· Seattle, WA

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