Phase I/II Trial of the Safety, Immunogenicity, and Efficacy of Autologous Dendritic Cells Transduced With Adenoviruses Encoding the MART-1 and gp100 Melanoma Antigens Administered With or Without Low Dose Recombinant Interleukin-2 (rIL-2) in Patients With Stage IV Melanoma
OBJECTIVES: I. Evaluate the safety, dose-limiting toxicity, and maximum tolerated dose of
autologous dendritic cells transduced with adenoviruses encoding the MART-1 and gp100
melanoma antigens with or without interleukin-2 in patients with stage III or IV melanoma.
II. Evaluate the cellular response and efficacy of these regimens in this patient
population.
OUTLINE: This is a dose-escalation study. Patients are sequentially assigned to one of three
dose levels. Patients receive modified autologous dendritic cells subcutaneously on day 1
with or without interleukin-2 IV on days 4-19. Treatment continues every 21 days for a total
of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of modified dendritic cells with or without interleukin-2
until the maximum tolerated dose (MTD) for each regimen is reached. The MTD is defined as
the dose below that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 24-36 patients will be accrued for this study within 1
year.
Interventional
Primary Purpose: Treatment
Amy E. Bock
Study Chair
Genzyme
United States: Federal Government
CDR0000067245
NCT00004025
March 1999
Name | Location |
---|---|
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
U.S. Oncology | Houston, Texas 77060 |