NCT00004073

Suramin Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Phase II Study of Suramin and Concurrent Radiation Therapy in Newly Diagnosed Glioblastoma Multiforme

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Suramin may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining suramin with radiation therapy may be a more effective treatment for glioblastoma multiforme. PURPOSE: Phase II trial to study the effectiveness of suramin plus radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

Detailed description

OBJECTIVES: I. Assess the toxicity of suramin administered prior to and concurrent with radiotherapy in patients with newly diagnosed high grade glioblastoma multiforme. II. Evaluate this regimen in terms of survival in this patient population. OUTLINE: Patients receive suramin IV over 2 hours for initial dose and over 1 hour for subsequent doses daily for 5 days on week 1. Patients receive concurrent radiotherapy daily with suramin IV over 1 hour twice weekly on weeks 2-7. Patients with stable or responsive disease receive a second course of suramin twice weekly on weeks 20-24. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months until disease progression or start of new therapy and then monthly for survival. PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study over 1.5 years.

Conditions

• Brain and Central Nervous System Tumors

Interventions

Type	Name	Description
DRUG	suramin
RADIATION	radiation therapy

Timeline

• Start date: 1999-12-01
• Primary completion: 2003-05-01
• Completion: 2004-06-01
• First posted: 2004-05-20
• Last updated: 2012-05-03

Locations

9 sites across 1 country: United States