Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma

Phase 1

Completed

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00003876
• Lead Sponsor: Barrett Cancer Center

Brief Summary

RATIONALE: Internal radiation uses high-energy radiation to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining internal radiation therapy with chemotherapy implants may kill remaining tumor cells following surgery.

PURPOSE: Phase I trial to study the effectiveness of internal radiation therapy plus carmustine implants in treating patients who have recurrent or refractory malignant glioma.

Detailed Description

OBJECTIVES: I. Assess the toxic effects of concurrent permanent iodine I 125 interstitial seed implants and polifeprosan 20 with carmustine implant (Gliadel wafers) in patients with recurrent or refractory malignant glioma. II. Assess preliminary efficacy of this regimen in terms of progression free survival and overall survival of these patients. III. Assess impact of this regimen on the quality of life and performance status of these patients. IV. Assess site of tumor progression following this regimen in these patients. V. Assess the relationship between progression free survival and the MIB-1 proliferative index of the resected malignant glioma.

OUTLINE: This is a dose escalation study. Patients undergo craniotomy with the intent to obtain a complete resection of enhancing tumor. Following maximum tumor removal, iodine I 125 seeds and up to 8 polifeprosan 20 with carmustine implants (Gliadel wafers) are implanted into the resected tumor cavity. Cohorts of 6 patients each receive increasing numbers of Gliadel wafers placed into the tumor cavity. Quality of life is assessed at baseline, then every 3 months, and at tumor progression. Patients are followed monthly until death.

PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study within 18 months.

Study Timeline

• Study Start: 1999-04
• Study First Submitted: 1999-11-01
• Status Verified: 2001-05
• Study Completion: 2004-05
• Study First Submitted QC: 2004-05-19
• Study First Posted: 2004-05-20
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Barrett Cancer Center, The University Hospital; 🇺🇸 Cincinnati, Ohio, United States