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| Sponsors and Collaborators: |
Herbert Irving Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00007982 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Head and Neck Cancer Lymphoma |
Biological: filgrastim Drug: carmustine Drug: cisplatin Drug: cyclophosphamide Drug: etoposide Drug: thiotepa Procedure: adjuvant therapy Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor |
| Estimated Enrollment: | 30 |
| Study Start Date: | April 1999 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant tumors
Pretreatment considerations based on tumor type
Anaplastic astrocytoma:
Oligodendroglioma:
Esthesioneuroblastoma:
CNS lymphoma:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| Study Chair: | Charles S. Hesdorffer, MD | Herbert Irving Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000068360, CPMC-IRB-8445, CPMC-CAMP-004A, NCI-G00-1881 |
| Study First Received: | January 6, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00007982 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 lymphoma adult anaplastic oligodendroglioma |
|
Immunologic Factors Central Nervous System Lymphoma, Primary Central Nervous System Neoplasms Cyclophosphamide Etoposide phosphate Cisplatin Lymphoma Etoposide Alkylating Agents Nervous System Neoplasms Immunoproliferative Disorders Astrocytoma Carmustine |
Adjuvants, Immunologic Immunosuppressive Agents Recurrence Thiotepa Lymphatic Diseases Brain Neoplasms Head and Neck Neoplasms Medulloblastoma Oligodendroglioma Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Antirheumatic Agents |
|
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Central Nervous System Neoplasms Cyclophosphamide Neoplasms by Site Therapeutic Uses Lymphoma Alkylating Agents Nervous System Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Carmustine Nervous System Diseases Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Head and Neck Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Lymphoproliferative Disorders Antirheumatic Agents |
