Clinical trial NCT00004073: Suramin Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Official title: Phase II Study of Suramin and Concurrent Radiation Therapy in Newly Diagnosed Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain and Central Nervous System Tumors
Keywords: adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-05-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility criteria: DISEASE CHARACTERISTICS: Histologically confirmed supratentorial glioblastoma multiforme No prior intracranial or intratumoral hemorrhage

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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Comprehensive Cancer Center
state: Alabama
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital - Atlanta
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania Cancer Center
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: John J. Laterra, MD, PhD
role: STUDY_CHAIR
References:
citation: Laterra JJ, Grossman SA, Carson KA, Lesser GJ, Hochberg FH, Gilbert MR; NABTT CNS Consortium study. Suramin and radiotherapy in newly diagnosed glioblastoma: phase 2 NABTT CNS Consortium study. Neuro Oncol. 2004 Jan;6(1):15-20. doi: 10.1215/S1152851703000127.