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Home > "S" Clinical Trials Conditions > Suramin Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

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



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

For Condition: adult glioblastoma multiforme
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Johns Hopkins University
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed supratentorial glioblastoma multiforme - No prior intracranial or intratumoral hemorrhage --Prior/Concurrent Therapy-- - Biologic therapy: No prior immunotherapy or biologic agents (e.g., immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, lymphokine activated killer cells, tumor infiltrating lymphocytes, or gene therapy) for brain tumor - Chemotherapy: No prior chemotherapy for brain tumor - Endocrine therapy: No prior hormonal therapy for brain tumor; Prior glucocorticoids allowed; Maintenance 5 day stable corticosteroid regimen required postsurgery - Radiotherapy: No prior radiotherapy for brain tumor - Surgery: Prior surgery for brain tumor allowed if recovered from the immediate post operative period --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Greater than 2 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL; No history of a bleeding disorder that would interfere with protocol therapy - Hepatic: Bilirubin no greater than 1.5 mg/dL; Transaminases no greater than 4 times upper limit of normal - Renal: Creatinine no greater than 1.7 mg/dL - Cardiovascular: No suspected disseminated intravascular coagulation; No history of venous thrombosis requiring coumadin - Other: No serious concurrent infection or other medical illness that would prevent compliance; No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JohnLaterra,  Study Chair,  Johns Hopkins University

University of Pennsylvania Cancer Center
Philadelphia,  Pennsylvania,  19104
United States
 

Emory University Hospital - Atlanta
Atlanta,  Georgia,  30322
United States
 

University of Alabama Comprehensive Cancer Center
Birmingham,  Alabama,  35294
United States
 

Massachusetts General Hospital Cancer Center
Boston,  Massachusetts,  02114
United States
 

University of Texas Health Science Center at San Antonio
San Antonio,  Texas,  78284-7811
United States
 

Henry Ford Hospital
Detroit,  Michigan,  48202
United States
 

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem,  North Carolina,  27157-1082
United States
 

H. Lee Moffitt Cancer Center and Research Institute
Tampa,  Florida,  33612
United States
 

Johns Hopkins Oncology Center
Baltimore,  Maryland,  21231
United States
 


Additional Information:
Study ID Numbers:
  CDR0000067281;  JHOC-NABTT-9808,NABTT-9808
Study Start Date: December 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004073

Other Adult Glioblastoma Multiforme Studies:
1. Temozolomide Plus Carboplatin in Treating Patients With Recurrent Glioblastoma Multiforme

2. Sirolimus in Treating Patients With Glioblastoma Multiforme

3. EMD 121974 in Treating Patients With Progressive or Recurrent Glioma

4. Irinotecan Plus Radiation Therapy Followed By Chemotherapy in Treating Patients With Glioblastoma Multiforme

5. Radiation Therapy in Treating Patients With Glioblastoma

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