Immunotherapy for Malignant Glioma - Phase II Trial of Autologous Cancer Antigen Specific Immunotherapy
- Determine the efficacy of immunotherapy with irradiated autologous tumor cell vaccine
and adoptive immunotherapy, in terms of time to progression and median and one-year
survival, in patients with primary or recurrent malignant astrocytoma or
- Determine the immunogenicity of malignant gliomas in patients treated with this
OUTLINE: Patients are stratified according to extent of disease, extent of antigen-specific
response to vaccination, performance status (0 vs 1), prior therapy (yes vs no), and gender.
Patients undergo tumor resection on week 1. Patients without recurrent disease receive local
radiotherapy on weeks 2-8. Beginning week 10-12, patients are vaccinated with irradiated
autologous tumor cells and sargramostim (GM-CSF) and then receive GM-CSF alone intradermally
at vaccination sites daily for 4 days. Patients are revaccinated 4 weeks later and may
receive up to 3 additional vaccinations every 2 weeks until a response is detected.
Patients undergo peripheral blood mononuclear cell collection on week 14 followed by
monoclonal antibody OKT3-activated T lymphocytes IV over 1-6 hours with alternating
interleukin-2 IV once every other day for 5 doses over 10 days beginning on week 16.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients may receive one additional course of immunotherapy as above.
Patients are followed at 1 week, monthly for 3 months, every 3 months for 2 years, and then
every 6 months thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Andrew E. Sloan, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|