Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients With Central Nervous System Cancer
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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 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor |
- Response rate [ Designated as safety issue: No ]
- Disease-free suvival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 1999 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00007982 History of Changes |
| Other Study ID Numbers: | CDR0000068360, CPMC-IRB-8445, CPMC-CAMP-004A, NCI-G00-1881 |
| Study First Received: | January 6, 2001 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Lymphoma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Nervous System Diseases Carmustine Cyclophosphamide Thiotepa |
Cisplatin Etoposide Lenograstim Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Myeloablative Agonists |
ClinicalTrials.gov processed this record on May 19, 2013