Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma
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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 Drug: thiotepa Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: 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 |
- Response rate [ Designated as safety issue: No ]
- Disease-free interval [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Designated as safety issue: No ]
- Presence of high-dose thiotepa in the cerebrospinal fluid [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 1997 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00008008 History of Changes |
| Other Study ID Numbers: | CDR0000068362, CPMC-IRB-8017, CPMC-CAMP-013, NCI-G00-1883 |
| Study First Received: | January 6, 2001 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adult anaplastic ependymoma 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 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) |
Additional relevant MeSH terms:
|
Astrocytoma Ependymoma Glioblastoma Glioma Nervous System Neoplasms Oligodendroglioma Central Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Neoplasms by Site Nervous System Diseases Cyclophosphamide Thiotepa Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013