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Brachytherapy in Treating Patients With Recurrent Malignant Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - 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.
PATIENT CHARACTERISTICS: Age.
  • - 18 and over.
Performance status.
  • - Karnofsky 60-100% Life expectancy.
  • - Not specified.
Hematopoietic.
  • - Absolute neutrophil count at least 1,500/mm^3.
  • - Platelet count at least 100,000/mm^3.
Hepatic.
  • - Not specified.
Renal.
  • - Creatinine no greater than 1.7 mg/dL.
  • - BUN no greater than 2 times upper limit of normal.
Cardiovascular.
  • - No uncontrolled hypertension.
  • - No unstable angina pectoris.
  • - No uncontrolled cardiac dysrhythmia.
Other.
  • - 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.
PRIOR CONCURRENT THERAPY: 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) Chemotherapy.
  • - 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.
Radiotherapy.
  • - See Disease Characteristics.
  • - No concurrent radiosurgery.
Surgery.
  • - See Disease Characteristics.
  • - See Radiotherapy.
Other.
  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00045474
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Larry Kleinberg, MD
Principal Investigator Affiliation Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Address

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3295

Tampa, Florida

Status

Address

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497

Atlanta, Georgia

Status

Address

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

Baltimore, Maryland

Status

Address

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410

Boston, Massachusetts

Status

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Detroit, Michigan

Status

Address

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202

Winston-Salem, North Carolina

Status

Address

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1030

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio

Status

Address

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195

Philadelphia, Pennsylvania

Status

Address

Abramson Cancer Center at University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104-4283