A Phase II Trial of Active Specific Immunotherapy in Patients With Recurrent Soft Tissue Sarcoma Using Autologous Tumor-derived Heat Shock Protein-Peptide Complex (HSPPC-96)
OBJECTIVES: I. Determine the efficacy of autologous tumor cell-derived heat shock protein
peptide vaccine in terms of the rate of complete and partial response and time to
progression in patients with recurrent soft tissue sarcoma. II. Determine the safety and
tolerability of this treatment regimen in this patient population. III. Determine the
anti-tumor response to this treatment regimen in these patients.
OUTLINE: At approximately 5 weeks after surgery, patients receive autologous tumor
cell-derived heat shock protein peptide vaccine intradermally weekly for 4 weeks. Patients
receive subsequent vaccinations once every 2 weeks for at least 12 weeks in the absence of
disease progression or unacceptable toxicity. Patients with improving or stable disease or
without recurrence continue on therapy for up to 1 year.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Primary Purpose: Treatment
Robert Maki, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|