Therapeutic Autologous Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Metastatic Melanoma

PRIMARY OBJECTIVES:

I. Assess the safety and toxicity of adoptively transferred IL-21 modulated CTL targeting a
melanoma associated antigen in patients following cyclophosphamide conditioning.

II. Evaluate the functional and numeric in vivo persistence of adoptively transferred IL-21
modulated CTL and factors contributing to immunopotentiation in patients receiving IL-21
modulated CTL following cyclophosphamide conditioning.

SECONDARY OBJECTIVES:

I. Evaluate the antitumor effect of adoptively transferred IL-21 modulated CD8+
antigen-specific CTL following cyclophosphamide conditioning and post-infusion IL-2.

OUTLINE: Patients receive cyclophosphamide IV on days -3 and -2 followed by an infusion of
IL-21 modulated, MART-1 specific CD8+ cytotoxic T lymphocytes over 30-60 minutes on day 0.
Beginning within 24 hours of T- cell infusion, patients receive low-dose aldesleukin
subcutaneously twice daily for 14 days in the absence of disease progression or unacceptable
toxicity.

After completion of study treatment, patients are followed for 8-10 weeks.