Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Suramin in Treating Patients With Recurrent Primary Brain Tumors
This study has been completed.
Sponsors and Collaborators: Emory University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002639
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with recurrent primary brain tumors following radiation therapy.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: suramin
Procedure: chemotherapy
Phase II

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors
Drug Information available for: Suramin Suramin Hexasodium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: ANALYSIS OF THE EFFICACY OF SURAMIN IN RECURRENT MALIGNANT PRIMARY BRAIN TUMORS

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 1995
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002639

Locations
United States, Georgia
Department of Neurosurgery - Emory
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Study Chair: Jeffrey J. Olson, MD Emory University
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000064118, EUC-DON-9420, NCI-T94-0033O
Study First Received: November 1, 1999
Last Updated: November 22, 2008
ClinicalTrials.gov Identifier: NCT00002639  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:
Brain Neoplasms
Glioblastoma
Astrocytoma
Suramin
Central Nervous System Diseases
Oligodendroglioma
Glioma
Central Nervous System Neoplasms
Brain Diseases
Gliosarcoma
Recurrence
Nervous System Neoplasms

Additional relevant MeSH terms:
Trypanocidal Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Nervous System Diseases
Anthelmintics
Pharmacologic Actions
Antinematodal Agents

ClinicalTrials.gov processed this record on January 14, 2009