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Brachytherapy in Treating Patients With Recurrent Malignant Glioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
adjuvant therapy
iodine I 125
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • H. Lee Moffitt Cancer Center and Research Institute
  • Winship Cancer Institute of Emory University
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Massachusetts General Hospital Cancer Center
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Comprehensive Cancer Center at Wake Forest University
  • Cleveland Clinic Taussig Cancer Center
  • Abramson Cancer Center at University of Pennsylvania Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 6, 2002
Last Updated
February 6, 2009
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00045474
Brief Title
Brachytherapy in Treating Patients With Recurrent Malignant Glioma
Official Title
Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2003
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
iodine I 125

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Kleinberg, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3295
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1030
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Abramson Cancer Center at University of Pennsylvania Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States

12. IPD Sharing Statement

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Brachytherapy in Treating Patients With Recurrent Malignant Glioma

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