A Phase I Trial of Intra Lesional RV-B7.1 Vaccine in the Treatment of Malignant Melanoma
I. Determine the maximum tolerated dose of the rV-B7.1 vaccine that elicits a host immune
response and is associated with acceptable toxicity in patients with malignant metastatic
II. Determine all clinical toxicities associated with this regimen in this patient
III. Determine the safety of this regimen in this patient population. IV. Assess evidence of
host antimelanoma immune reactivity following this regimen.
V. Determine the effect of this regimen on T-cell immunity. VI. Assess the clinical response
in this patient population receiving this regimen.
VII. Evaluate quality of life of these patients during this regimen.
OUTLINE: This is a dose escalation study.
Patients receive rV-B7.1 intralesionally every 4 weeks for 8 weeks (weeks 0, 4, and 8).
Treatment continues every 12 weeks in the absence of unacceptable toxicity or disease
progression for up to 2 courses. Cohorts of 6-8 patients receive escalating doses of vaccine
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which 2 of 6 or 3 of 8 patients experience dose limiting toxicities.
Quality of life is assessed before treatment, every 4 weeks, and at end of treatment.
Patients are followed every 3 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Howard L. Kaufman, MD
Albert Einstein College of Medicine of Yeshiva University
United States: Food and Drug Administration
|Albert Einstein Comprehensive Cancer Center||Bronx, New York 10461|