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
N/A
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
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
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant glioma
- Primary or recurrent glioblastoma multiforme (including gliosarcoma) following
surgery and radiotherapy or prior conventional chemotherapy (e.g., carmustine or
procarbazine, vincristine, and lomustine)
- Recurrent or refractory anaplastic astrocytoma following any prior therapy (must
be chemoresistant)
- Recurrent or refractory ependymoma or primitive neuroectodermal tumor (PNET)
following any prior therapy
- Recurrent or refractory oligodendroglioma or oligoastrocytoma following any
prior therapy (must be chemoresistant)
- Evaluable disease on gadolinium-enhanced MRI
- Ineligible for other high priority national or institutional study (e.g., protocol
CAMP-004)
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Creatinine less than 1.5 times normal
Cardiovascular:
- LVEF at least 45% by MUGA
Pulmonary:
- DLCO at least 60% of predicted OR
- Approval by pulmonologist
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent anticancer hormonal therapy
- No concurrent steroids as antiemetics
Radiotherapy:
- See Disease Characteristics
- See Surgery
Surgery:
- See Disease Characteristics
- For patients with glioblastoma multiforme, concurrent surgery and/or stereotactic
radiosurgery to reduce tumor bulk allowed
Other:
- No concurrent acetaminophen during chemotherapy
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Safety Issue:
No
Principal Investigator
Charles S. Hesdorffer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Herbert Irving Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068362
NCT ID:
NCT00008008
Start Date:
September 1997
Completion Date:
May 2008
Related Keywords:
- Brain and Central Nervous System Tumors
- childhood infratentorial ependymoma
- childhood supratentorial ependymoma
- recurrent adult brain tumor
- adult medulloblastoma
- adult glioblastoma
- adult oligodendroglioma
- childhood high-grade cerebral astrocytoma
- childhood oligodendroglioma
- adult anaplastic astrocytoma
- adult anaplastic ependymoma
- adult mixed glioma
- recurrent childhood supratentorial primitive neuroectodermal tumor
- recurrent childhood cerebellar astrocytoma
- recurrent childhood cerebral astrocytoma
- recurrent childhood ependymoma
- adult giant cell glioblastoma
- adult gliosarcoma
- adult supratentorial primitive neuroectodermal tumor (PNET)
- Astrocytoma
- Ependymoma
- Glioblastoma
- Glioma
- Nervous System Neoplasms
- Oligodendroglioma
- Central Nervous System Neoplasms
- Neuroectodermal Tumors
- Neuroectodermal Tumors, Primitive
Name | Location |
|---|---|
| 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 |
