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

Phase 2
Completed
Conditions
Brain and Central Nervous System Tumors
Registration Number
NCT00004073
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
54
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (9)

University of Alabama Comprehensive Cancer Center

🇺🇸

Birmingham, Alabama, United States

H. Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

Emory University Hospital - Atlanta

🇺🇸

Atlanta, Georgia, United States

Johns Hopkins Oncology Center

🇺🇸

Baltimore, Maryland, United States

Massachusetts General Hospital Cancer Center

🇺🇸

Boston, Massachusetts, United States

Henry Ford Hospital

🇺🇸

Detroit, Michigan, United States

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

🇺🇸

Winston-Salem, North Carolina, United States

University of Pennsylvania Cancer Center

🇺🇸

Philadelphia, Pennsylvania, United States

University of Texas Health Science Center at San Antonio

🇺🇸

San Antonio, Texas, United States

University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States

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