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

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

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

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

John J. Laterra, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:

NABTT-9808 CDR0000067281



Start Date:

December 1999

Completion Date:

June 2004

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
Johns Hopkins Oncology Center Baltimore, Maryland  21287
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
Henry Ford Hospital Detroit, Michigan  48202