CAMP 013:- Tandem Thiotepa Regimen For Selected Malignant Gliomas:1) Primary Or Recurrent Glioblastoma Multiforme (GBM); and 2) Recurrent Anaplastic Astrocytomas (AA), Oligodendrogliomas (O), Oligoastrocytomas (OA), Ependymomas And Primitive Neuroectodermal Tumors (PNET) That Have Either Progressed After Primary Therapy Or Are Refractory To Standard Chemotherapy
- Determine the response rate, disease-free interval, and overall survival of patients
with malignant glioma treated with high-dose thiotepa followed by autologous peripheral
blood stem cell transplantation.
- Determine the toxicity of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine whether this drug enters the cerebrospinal fluid of these patients.
OUTLINE: Following a course of induction chemotherapy with cyclophosphamide IV over 4 hours,
patients receive filgrastim (G-CSF) daily until the completion of peripheral blood stem cell
(PBSC) harvesting. PBSCs are collected over 3-5 days. Patients who do not mobilize
sufficient cells undergo bone marrow harvest.
Patients receive high-dose thiotepa IV over 5 hours on day -2. PBSCs or bone marrow are
reinfused on day 0. Patients receive sargramostim (GM-CSF) subcutaneously daily beginning on
day 0 and continuing until blood counts recover. Treatment repeats every 2-3 weeks for a
total of 1-4 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, at every course, then monthly for 6 months, and
then every 2 months thereafter.
Patients are followed monthly for 6 months and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 5-40 patients will be accrued for this study within 3 years.
Masking: Open Label, Primary Purpose: Treatment
Charles S. Hesdorffer, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|St. Joseph's Hospital and Medical Center||Paterson, New Jersey 07503|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center||New York, New York 10032|