Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
AVAX Technologies
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.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
