Radiation Therapy in Treating Patients With Progressive or Recurrent Malignant Brain Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

2004-06-30

Brief Summary

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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who are undergoing surgical removal of progressive or recurrent malignant brain tumors.

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Detailed Description

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OBJECTIVES: I. Evaluate the safety of the GliaSite RTS in patients with progressive or recurrent malignant brain tumors undergoing surgical resection. II. Evaluate the performance of the GliaSite RTS in these patients.

OUTLINE: This is an open label, multicenter study. Patients undergo surgical resection of the tumor followed by surgical placement of the GliaSite device in the resection cavity. One to 2 weeks after surgery, patients receive brachytherapy consisting of an infusion of iodine I-125. The I-125 solution is removed and collected 5-7 days later. The device is surgically removed within 24 hours. Patients are followed at 24 hours, 14 days, and 1 year post device removal.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Conditions

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Brain and Central Nervous System Tumors

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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surgical procedure

Intervention Type PROCEDURE

brachytherapy

Intervention Type RADIATION

intraoperative radiation therapy

Intervention Type RADIATION

iodine I 125

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension, angina pectoris, or uncontrolled cardiac dysrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No serious concurrent infection or other medical illness No prior or concurrent malignancy within 5 years except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: See Disease Characteristics No concurrent chemotherapy At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: At least 4 weeks since prior use of medical device No concurrent investigational agents

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No