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Suramin in Treating Patients With Recurrent Primary Brain Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002639
First received: November 1, 1999
Last updated: June 20, 2013
Last verified: February 2001
  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: chemotherapy
Drug: suramin
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: ANALYSIS OF THE EFFICACY OF SURAMIN IN RECURRENT MALIGNANT PRIMARY BRAIN TUMORS

Resource links provided by NLM:


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

Study Start Date: July 1995
Study Completion Date: May 2004
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Winship Cancer Institute of Emory University
Investigators
Study Chair: Jeffrey J. Olson, MD Winship Cancer Institute of Emory University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002639     History of Changes
Other Study ID Numbers: CDR0000064118, EUC-DON-9420, NCI-T94-0033O
Study First Received: November 1, 1999
Last Updated: June 20, 2013
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

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

ClinicalTrials.gov processed this record on November 25, 2014