Phase I Study To Evaluate Cellular Adoptive Immunotherapy Using Autologous CD8+ Antigen-Specific T Cell Clones Following Cyclophosphamide Conditioning For Patients With Metastatic Melanoma
PRIMARY OBJECTIVES:
I. To assess the safety and toxicity of cellular adoptive immunotherapy in melanoma patients
receiving autologous CD8+ antigen-specific T cell clones following cyclophosphamide
conditioning and post-infusion IL-2.
II. To assess the duration of in vivo persistence of adoptively transferred CD8+ T cell
clones.
SECONDARY OBJECTIVES:
I. Evaluate the antitumor effect of adoptively transferred CD8+ antigenspecific cytotoxic t
lymphocytes (CTL) clones following cyclophosphamide conditioning and post-infusion IL-2.
OUTLINE:
Patients are assigned 1of 2 treatment cohorts.
All patients receive high-dose cyclophosphamide intravenously (IV) on days -3 and -2 and
autologous antigen-specific cytotoxic CD8+ T lymphocyte clones IV over 30-60 minutes on day
0.
COHORT I: Beginning within 6 hours of T cell infusion, patients receive low-dose aldesleukin
subcutaneously (SC) twice daily on days 0-14.
COHORT II: Beginning within 6 hours of T cell infusion, patients receive high-dose
aldesleukin IV 3 times daily on days 0-5.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks, 8 weeks, and every
3 months thereafter for up to 1 year.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The identification of a CY/IL-2 regimen that is considered to be safe
Baseline, 4 weeks and 8 weeks
Yes
Cassian Yee
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
2140.00
NCT00438984
December 2006
February 2012
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |