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Brachytherapy in Treating Patients With Recurrent Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00045474
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Brachytherapy uses radioactive material to kill cancer cells remaining after surgery.

PURPOSE: Phase I trial to study the effectiveness of brachytherapy in treating patients who have recurrent malignant glioma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Procedure: adjuvant therapy Radiation: iodine I 125 Phase 1

Detailed Description:


  • Determine the maximum tolerated dose of brachytherapy using an intracavitary applicator and liquid iodine I 125 in patients with recurrent malignant glioma.
  • Determine the acute and chronic toxicity of this therapy in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Within 3-21 days after surgical resection, patients receive brachytherapy using an intracavity balloon application (GliaSite) with iodine I 125 solution for a total of 5-7 days.

Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 10 patients experience dose-limiting toxicity.

Patients are followed at 4 weeks and then every 2 months for 1 year.

PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas
Study Start Date : October 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant glioma

    • Anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme

      • Low-grade astrocytoma that progresses to high-grade astrocytoma allowed
    • Unifocal disease
    • Progressive or recurrent after radiotherapy with or without chemotherapy

      • Previously treated with at least 5,000 cGy external beam radiotherapy more than 3 months ago
  • Candidate for maximal surgical resection

    • Any expected residual enhancing tumor must be within expected brachytherapy treatment volume
    • Resection must not be expected to result in a new permanent neurologic deficit
  • No tumor crossing more than 1 cm beyond the midline on preoperative MRI or CT scan
  • No grossly or radiographically apparent leptomeningeal spread
  • No ventricular invasion outside the anticipated radiotherapy treatment volume
  • No marked edema on MRI or CT scan
  • Patients with 2 or more separate foci of contrast-enhancing tumors that are more than 5 cm apart on preoperative MRI or CT scan are ineligible



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Not specified


  • Creatinine no greater than 1.7 mg/dL
  • BUN no greater than 2 times upper limit of normal


  • No uncontrolled hypertension
  • No unstable angina pectoris
  • No uncontrolled cardiac dysrhythmia


  • Mini mental score at least 15
  • No other medical illness that would preclude study participation
  • No serious infection
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy

  • No concurrent immunotherapy
  • No concurrent biologic agents (e.g., immunotoxins, immunoconjugates, antiangiogenesis compounds, antisense therapy, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy)


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No concurrent polifeprosan 20 with carmustine implant (Gliadel wafer)

Endocrine therapy

  • Concurrent corticosteroids allowed to improve quality of life


  • See Disease Characteristics
  • No concurrent radiosurgery


  • See Disease Characteristics
  • See Radiotherapy


  • Recovered from prior therapy
  • No prior investigational agents
  • No investigational agents during and for 90 days after study participation
  • Concurrent cytotoxic treatment allowed to improve quality of life

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00045474

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United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3295
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1030
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Larry Kleinberg, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Layout table for additonal information Identifier: NCT00045474     History of Changes
Other Study ID Numbers: CDR0000256587
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: April 2003

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

Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases