- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00007982
Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients With Central Nervous System Cancer
CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well chemotherapy and peripheral stem cell transplant work in treating patients with central nervous system cancer.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Response rate
|
Overall survival
|
Quality of life
|
Disease-free suvival
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Charles S. Hesdorffer, MD, Herbert Irving Comprehensive Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
- recurrent adult brain tumor
- adult anaplastic astrocytoma
- adult anaplastic oligodendroglioma
- adult central nervous system germ cell tumor
- adult medulloblastoma
- adult oligodendroglioma
- primary central nervous system non-Hodgkin lymphoma
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Cyclophosphamide
- Etoposide
- Thiotepa
- Carmustine
Other Study ID Numbers
- CDR0000068360
- CPMC-IRB-8445
- CPMC-CAMP-004A
- NCI-G00-1881
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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