Melanoma (Skin) Clinical Trial
Official title:
A Prospective, Randomized, Open-Label, Comparative Clinical Trial in Post-Surgical Melanoma Patients With Either DNP-Modified Autologous Tumor Vaccine or Interferon Alpha-2b
RATIONALE: Vaccines made from a person's melanoma cells may make the body build an immune
response to kill tumor cells. Interferon alfa may interfere with the growth of the cancer
cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of melanoma vaccine with
that of interferon alfa-2b in treating patients who have stage III melanoma that has spread
to regional lymph nodes following surgery.
OBJECTIVES: I. Compare the relapse-free and overall survival rates in patients with stage
III melanoma treated with autologous tumor vaccine versus interferon alfa-2b as postsurgical
adjuvant therapy. II. Compare the safety and tolerability of these regimens in this patient
population.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to number of metastatic lymph node sites (1 vs more than 1), number of positive
lymph nodes in a single site (none vs 1 or more), presence of intransit metastases (yes vs
no), and evidence of extranodal extension (yes vs no). Patients are randomized to one of two
treatment arms. Arm I: Patients receive autologous tumor cell vaccine intradermally once a
week for 7 weeks followed by a booster injection at 6 months. BCG is given concurrently with
vaccine as an immune-stimulator for doses 2-8. Patients also receive cyclophosphamide 6 days
after the first vaccine injection. Arm II: Patients receive interferon alfa-2b IV for 5
consecutive days a week for 4 weeks followed by maintenance doses given subcutaneously 3
times a week for 48 weeks. Patients are followed monthly for 1 year, every 2 months for 1
year, every 3 months for 1 year, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 386-425 patients will be accrued for this study.
;
Allocation: Randomized, Primary Purpose: Treatment
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