CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor
18 Years
N/A
Both
Brain and Central Nervous System Tumors, Head and Neck Cancer, Lymphoma
Trial Information
CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor
OBJECTIVES:
- Determine the response rate in patients with central nervous system malignancies
treated with intensive chemotherapy supported by autologous peripheral blood stem cell
transplantation following surgical resection and/or radiotherapy.
- Determine the disease-free survival and overall survival of this patient population
treated with these regimens.
- Determine the toxicity of this high-dose chemotherapy regimen in these patients.
- Assess the quality of life of these patients following these treatment regimens.
OUTLINE: Patients with anaplastic astrocytoma, esthesioneuroblastoma, germ cell tumor, or
primary neuroectodermal tumor undergo initial surgical resection followed by conventional or
stereotactic radiotherapy. Patients with germ cell or primary neuroectodermal tumors also
receive 4 courses of standard chemotherapy comprising cyclophosphamide, etoposide, and
cisplatin prior to high-dose chemotherapy.
All patients undergo peripheral blood stem cell or bone marrow harvest followed by high-dose
chemotherapy consolidation. Patients receive thiotepa IV 3 times daily on days -7 to -3,
carmustine IV over 1 hour on days -6 to -3, and etoposide IV over 5 hours on days -6 to -3.
Patients then undergo transplantation on day 0. Filgrastim (G-CSF) is administered
concurrently with stem cell harvesting and transplantation.
Patients with recurrent oligodendroglioma or CNS lymphoma who have not received radiotherapy
at diagnosis undergo conventional radiotherapy 6 weeks after completion of high-dose
chemotherapy.
Patients are followed every 2-3 months for 1 year and then annually for 5 years. Quality of
life is assessed at follow-up.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant tumors
- Anaplastic astrocytoma
- Oligodendroglioma
- Germ cell tumor
- Medulloblastoma
- Primary neuroectodermal tumor
- Esthesioneuroblastoma
- CNS lymphoma (primary or systemic disease)
- Multifocal intracranial disease allowed
- No extraneural metastases (except controlled systemic lymphoma)
- Pretreatment considerations based on tumor type
- Anaplastic astrocytoma:
- Recurrent disease
- Any treatment at diagnosis allowed (carmustine dose limited to 480 mg/m2)
- Chemotherapy not required at recurrence
- Oligodendroglioma:
- Disease response (at least minor) to conventional chemotherapy OR
- Recurrent disease
- Esthesioneuroblastoma:
- Attempted complete surgical resection
- Disease progression after radiotherapy
- Response to chemotherapy regimen comprising cyclophosphamide, etoposide,
and cisplatin
- CNS lymphoma:
- Disease refractory to methotrexate OR
- Failure after initial treatment with methotrexate OR
- Considered at high risk for disease relapse despite initial response
- Radiographic or pathological confirmation of recurrent disease required
- Not eligible for other high priority national or institutional clinical studies
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG or Zubrod 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%
Pulmonary:
- DLCO at least 60% predicted OR
- Approval of pulmonologist
Other:
- Not pregnant or nursing
- 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
Surgery:
- See Disease Characteristics
Other:
- No concurrent barbiturates or acetaminophen
- Participation in other concurrent supportive care or gene therapy trials allowed
Type of Study:
Interventional
Study Design:
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:
CDR0000068360
NCT ID:
NCT00007982
Start Date:
April 1999
Completion Date:
May 2008
Related Keywords:
- Brain and Central Nervous System Tumors
- Head and Neck Cancer
- Lymphoma
- recurrent adult brain tumor
- adult medulloblastoma
- adult oligodendroglioma
- recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
- adult anaplastic astrocytoma
- adult central nervous system germ cell tumor
- primary central nervous system non-Hodgkin lymphoma
- adult anaplastic oligodendroglioma
- Head and Neck Neoplasms
- Lymphoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | New York, New York 10032 |
