A Phase II Trial Of Conventional Radiation Therapy Followed By Intratumoral Bleomycin Delivered Using A Refillable, Sustained Release Device (IND# 46,592) For The Treatment Of Supratentorial Glioblastoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Brain and Central Nervous System Tumors
- Sponsor
- Radiation Therapy Oncology Group
- Enrollment
- 19
- Locations
- 13
- Primary Endpoint
- Overall Survival
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by bleomycin in treating adult patients who have newly diagnosed supratentorial glioblastoma multiforme.
Detailed Description
OBJECTIVES: * Determine the median survival time of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy followed by sustained release intratumoral bleomycin. * Determine the feasibility of this regimen in these patients. OUTLINE: This is a multicenter study. Within 4 weeks after surgical resection, patients receive radiotherapy daily 5 days a week for 6 weeks. Within 2-6 weeks after completion of radiotherapy or at disease progression during radiotherapy, patients undergo surgical implantation of a modified Ommaya reservoir within the central area of the tumor. Patients then receive sustained release bleomycin intratumorally via the reservoir once a week for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 5 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall Survival
Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.