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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: | NCT00008008 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy with peripheral stem cell or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well thiotepa followed by peripheral stem cell or bone marrow transplant works in treating patients with malignant glioma.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Biological: filgrastim Biological: sargramostim Drug: cyclophosphamide Procedure: peripheral blood stem cell transplantation Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Drug: thiotepa |
Phase II |
| Study Type: | Interventional |
| Study Design: | Open Label, Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | September 1997 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant glioma
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 Jersey | |
| St. Joseph's Hospital and Medical Center | |
| Paterson, New Jersey, United States, 07503 | |
| 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: | CDR0000068362, CPMC-CAMP-013, CPMC-IRB-8017, NCI-G00-1883 |
| Study First Received: | January 6, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00008008 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult anaplastic astrocytoma adult anaplastic ependymoma adult giant cell glioblastoma adult glioblastoma adult gliosarcoma adult medulloblastoma adult mixed glioma adult oligodendroglioma adult supratentorial primitive neuroectodermal tumor (PNET) |
childhood high-grade cerebral astrocytoma childhood infratentorial ependymoma childhood oligodendroglioma childhood supratentorial ependymoma recurrent adult brain tumor recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood ependymoma recurrent childhood supratentorial primitive neuroectodermal tumor |
|
Glioblastoma Neuroectodermal Tumors, Primitive Astrocytoma Cyclophosphamide Central Nervous System Neoplasms Immunosuppressive Agents Ependymoma Recurrence Thiotepa Brain Neoplasms Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Medulloblastoma Neuroepithelioma Oligodendroglioma Antineoplastic Agents, Alkylating Glioblastoma Multiforme Glioma Antirheumatic Agents Gliosarcoma Alkylating Agents Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
|
Neuroectodermal Tumors, Primitive Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Central Nervous System Neoplasms Cyclophosphamide Neoplasms by Site Neoplasms, Germ Cell and Embryonal Therapeutic Uses Glioma Alkylating Agents Nervous System Neoplasms |
Neoplasms by Histologic Type Nervous System Diseases Immunosuppressive Agents Pharmacologic Actions Thiotepa Neuroectodermal Tumors Neoplasms Myeloablative Agonists Oligodendroglioma Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Neoplasms, Glandular and Epithelial |
