Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients With Central Nervous System Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CAMP 004A - Phase 2 Study Of Intensive Chemotherapy (BET) For Selected Categories Of Malignant Central Nervous System Tumor

Conditions
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Brain and Central Nervous System Tumors, Head and Neck Cancer, Lymphoma

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Drug: carmustine|nan|
|Drug: cisplatin|nan|
|Drug: cyclophosphamide|nan|
|Drug: etoposide|nan|
|Drug: thiotepa|nan|
|Procedure: adjuvant therapy|nan|
|Procedure: autologous bone marrow transplantation|nan|
|Procedure: bone marrow ablation with stem cell support|nan|
|Procedure: peripheral blood stem cell transplantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Disease-free suvival |  |  | 
| Overall survival |  |  | 
| Toxicity |  |  | 
| Quality of life |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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