Phase I/II Study in Patients With Metastatic Melanoma of Immunization With Dendritic Cells Presenting Epitopes Derived From The Melanoma Associated Antigens MART-1 and gp 100
- Evaluate the toxicity, immunologic reactivity, and possible therapeutic efficacy of
immunization with dendritic cells presenting the MART-1 and gp100 melanoma antigens
with or without interleukin-2 in patients with metastatic melanoma.
OUTLINE: This is a dose-escalation study of dendritic cells pulsed with MART-1 and gp100
Patients receive vaccinations with dendritic cells pulsed with MART-1 and gp100 antigens,
either intralymphatically every 4 weeks for 2 doses, or IV every 3 weeks for 4 doses. Some
patients also receive interleukin-2 subcutaneously or IV, over 3-5 days, beginning 24 hours
Cohorts of 2-9 patients receive escalating doses of pulsed dendritic cells IV until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 6 patients experience dose-limiting toxicity. Subsequent cohorts receive cells
with or without interleukin-2. One cohort may expand to 15 patients to determine the
accuracy of immunologic response to the vaccine.
One cohort of 11 patients receives cells intralymphatically without interleukin-2 every 3-4
weeks for 2 courses. Patients with stable disease or who achieve minor, mixed, or partial
response may be retreated.
Patients with stable or responding disease undergo a second course of vaccination. Patients
who completed treatment with vaccine alone and have stable disease, progressive disease,
disease progression after a response, or a partial response with no further improvement may
receive 2 additional courses.
PROJECTED ACCRUAL: A total of 10-42 patients will be accrued for this study.
Primary Purpose: Treatment
James C. Yang, MD
NCI - Surgery Branch
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|