NCT00007982

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Herbert Irving Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Brain and Central Nervous System Tumors
• Head and Neck Cancer
• Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 1999-04-01
• Primary completion: 2005-02-01
• Completion: 2008-05-01
• First posted: 2003-01-27
• Last updated: 2013-02-04

Locations

1 site across 1 country: United States