NCT00003309

Combination Chemotherapy Plus Radiation Therapy in Treating Adult Patients With Brain Cancer

A Phase II Trial of Preradiation Multiagent Chemotherapy for Adults With "Poor Risk" Medulloblastoma, PNET, and Disseminated Ependymoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy in treating adult patients with brain cancer.

Detailed description

OBJECTIVES: * Determine the complete and partial response rate of patients with adult medulloblastoma, primitive neuroectodermal tumor, or disseminated ependymoma treated with preradiation combination chemotherapy. * Determine the progression free survival and overall survival of these adult patients treated with combination chemotherapy followed by craniospinal radiation. * Determine the toxic effects associated with this treatment in these patients. OUTLINE: Patients receive cisplatin IV over 6 hours, etoposide IV, and vincristine IV over 1-2 minutes on day 1; etoposide IV and cyclophosphamide IV over 1-2 hours on days 2-3; filgrastim (G-CSF) subcutaneously (SC) on days 4-13; and vincristine IV over 1-2 minutes on day 15. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Within 4-6 weeks after the last chemotherapy course, patients undergo radiotherapy 5 days a week for 6 to 7 weeks. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5-10 years. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 3 years.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	cisplatin
DRUG	cyclophosphamide
DRUG	etoposide
DRUG	vincristine sulfate
PROCEDURE	adjuvant therapy
RADIATION	radiation therapy

Timeline

• Start date: 1999-05-04
• Primary completion: 2004-03-01
• First posted: 2003-01-27
• Last updated: 2023-06-22

Locations

14 sites across 1 country: United States