Phase I Study To Evaluate The Use Of Autologous T- Antigen-Presenting Cells (T-APC) To Enhance The Persistence Of Adoptively Transferred CD8+ Antigen-Specific T Cells (CTL) Following Cyclophosphamide Conditioning For Patients With Metastatic Melanoma
I. Assess the safety and toxicity of T-APC vaccination following adoptive T cell therapy.
II. Evaluate the functional and numeric in vivo persistence of adoptively transferred
cytotoxic t lymphocytes (CTL) followed by T-APC vaccination.
I. Evaluate the antitumor effect of adoptive T cell therapy followed by T-APC vaccination.
OUTLINE : This is a dose-escalation study of T-APC vaccine.
INFUSION I: Patients receive high-dose cyclophosphamide intravenously (IV) on days -4 and -3
and low-dose aldesleukin (IL-2) subcutaneously (SC) twice daily (BID) on days 0-14. Patients
also receive CTL IV on day 0.
INFUSION II: Beginning 6-48 hours later, patients receive high-dose cyclophosphamide,
low-dose IL-2, and CTL as in Infusion I. Patients also receive T-APC vaccine IV within 18-36
hours following CTL infusion and in week 4, and IL-2 SC BID on days 0-14 following second
After completion of study treatment, patients are followed up for 8 weeks.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment-related dose limiting toxicity (DLT) as defined by Grade 3 or greater unexpected toxicity by the NCI Common Toxicity Criteria (CTC) v4.0
Assessed at the maximum tolerated dose (MTD) or dose level immediately below the dose level for which the incidence of DLT was less than 35%.
Up to 8 weeks after the T cell infusion
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|