Know Cancer

or
forgot password

ANALYSIS OF THE EFFICACY OF SURAMIN IN RECURRENT MALIGNANT PRIMARY BRAIN TUMORS


Phase 2
15 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

ANALYSIS OF THE EFFICACY OF SURAMIN IN RECURRENT MALIGNANT PRIMARY BRAIN TUMORS


OBJECTIVES: I. Estimate the efficacy of suramin in patients with recurrent primary brain
tumors as measured by radiographic response, time to progression, and survival. II. Assess
the toxic effects of suramin in this patient population.

OUTLINE: Single-Agent Chemotherapy. Suramin, SUR, NSC-34936.

PROJECTED ACCRUAL: If at least 1 of the first 14 patients experiences at least a partial
response, a total of 25 patients will be entered over approximately 30 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Recurrent brain tumor based on one of the following: Tissue
diagnosis if there was a prior diagnosis of astrocytoma or oligodendroglioma or if there
is a question of radiation necrosis from prior interstitial brachytherapy Metabolic
activity in excess of normal cortex measured by 18-fluorodeoxyglucose uptake on PET One of
the following histologic types required: Glioblastoma multiforme Anaplastic astrocytoma
Anaplastic oligodendroglioma Anaplastic mixed glioma Tumor progression required, i.e.: 28%
increase in contrast-enhancing area or 50% increase in contrast- enhancing volume over at
least 4 weeks Measurable disease required No history, surgical findings, or radiographic
signs of intratumoral hemorrhage

PATIENT CHARACTERISTICS: Age: Over 15 Performance status: Karnofsky 50%-100% Life
expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000 Platelets at least 75,000
Hepatic: Bilirubin less than 1.5 mg/dL AST/ALT less than 3 times normal No history of
bleeding disorder No hepatic disease resulting in hospitalization Renal: Creatinine less
than 1.5 mg/dL No renal disease resulting in hospitalization Cardiovascular: No ongoing
anticoagulation for deep vein thrombosis (DVT) No residual symptoms from DVT after
discontinuation of anticoagulation No cardiac disease resulting in hospitalization
Pulmonary: No pulmonary disease resulting in hospitalization Other: No peripheral
neuropathy of any etiology HIV negative No pregnant or nursing women Adequate
contraception required during and for 12 months following protocol therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for glioblastoma multiforme No more than 1 prior chemotherapy regimen for
anaplastic astrocytoma, malignant oligodendroglioma, or malignant mixed glioma At least 4
weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin) Endocrine therapy: Not
specified Radiotherapy: Completion of 1 course of conventional external radiotherapy
required At least 4 weeks since radiotherapy Surgery: Decompressive surgery for clinically
suspected increased intracranial pressure performed prior to entry

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jeffrey J. Olson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Winship Cancer Institute of Emory University

Authority:

United States: Federal Government

Study ID:

CDR0000064118

NCT ID:

NCT00002639

Start Date:

July 1995

Completion Date:

May 2004

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Department of Neurosurgery - EmoryAtlanta, Georgia  30322