Suramin Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

May 1, 2012 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University Of Alabama Comprehensive Cancer Center
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital - Atlanta
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Oncology Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Cancer Center
    • Texas
      • San Antonio, Texas, United States, 78284-7811
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: John J. Laterra, MD, PhD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Primary Completion (Actual)

May 1, 2003

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

December 10, 1999

First Submitted That Met QC Criteria

May 19, 2004

First Posted (Estimate)

May 20, 2004

Study Record Updates

Last Update Posted (Estimate)

May 3, 2012

Last Update Submitted That Met QC Criteria

May 1, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NABTT-9808 CDR0000067281
  • P30CA006973 (U.S. NIH Grant/Contract)
  • U01CA062475 (U.S. NIH Grant/Contract)
  • NABTT-9808
  • JHOC-NABTT-9808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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