Phase II Trial Of High Dose Cyclophosphamide, Cisplatin And Carmustine With Stem Cell Reconstitution Followed By Specific Cellular Therapy In Patients With Recurrent Or Refractory Brain Tumors
- Determine the effectiveness of induction paclitaxel and cyclophosphamide followed by
autologous tumor cell vaccine and sargramostim (GM-CSF) followed by high-dose
chemotherapy with cisplatin, cyclophosphamide, and carmustine, autologous bone marrow
or peripheral blood stem cell transplantation, and interleukin-2 in patients with
recurrent or refractory primary high-grade brain tumors.
- Determine the safety and toxicity of this regimen in these patients.
- Determine if a specific quantitative cellular response can be elicited in patients
treated with this regimen.
OUTLINE: After partial surgical resection of tumor, patients receive induction chemotherapy
comprising paclitaxel IV over 3 hours and cyclophosphamide IV over 1 hour on day 1. Patients
also receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 3 and continuing
until peripheral blood stem cell (PBSC) or bone marrow collection is completed.
After the collection of PBSC or bone marrow, patients receive autologous tumor cell vaccine
and sargramostim (GM-CSF) SC once every 2 weeks for up to 5 vaccinations. Two weeks after
the last vaccination, patients undergo a second leukapheresis to collect lymphocytes.
After completion of the second leukapheresis, patients receive high-dose chemotherapy
comprising cisplatin IV continuously over 24 hours on day -5, cyclophosphamide IV over 1
hour on days -5, -4, and -3, and carmustine IV over 2 hours on day -2. Patients undergo
autologous bone marrow or PBSC transplantation on day 0. Patients receive G-CSF IV daily
beginning on day 0 and continuing until blood counts recover.
Approximately 12 weeks after bone marrow or PBSC transplantation, patients receive
autologous lymphocytes IV over 2-5 hours. Patients also receive interleukin-2 IV once every
other day for 10 days.
Patients are followed at 18, 24, 36, 40, and 52 weeks.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Esteban Abella, MD
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|