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Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
conventional surgery
brachytherapy
radiation therapy
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 glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Clinically suspected supratentorial grade IV glioblastoma multiforme Candidate for maximal surgical resection of tumor mass Expected residual enhancing tumor must be within the expected brachytherapy treatment volume Resection must not be expected to result in a new permanent neurologic deficit No clearly multi-focal disease (2 or more separate foci of contrast-enhancing tumor not all within the expected brachytherapy prescription volume by MRI) No enhancing tumor greater than 1 cm beyond the midline by MRI No grossly or radiographically apparent leptomeningeal spread and/or ventricular invasion outside the anticipated radiation treatment volume No marked edema by MRI with significant shift that is not anticipated to be corrected by resection 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 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Mini mental state exam score at least 15 No other concurrent medical illness that would preclude study participation No concurrent serious infection No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No immunotherapy prior to, during, or within 90 days after brachytherapy No biologic therapy with any of the following prior to, during, or within 90 days after brachytherapy : Immunotoxins Immunoconjugates Antiangiogenesis compounds Peptide receptor antagonists Interferons Interleukins Tumor-infiltrating lymphocytes Lymphokine-activated killer cells Gene therapy Antisense agents Chemotherapy No chemotherapy or polifeprosan 20 with carmustine implant (Gliadel wafers) prior to, during, or within 90 days after brachytherapy Endocrine therapy No hormonal therapy prior to, during, or within 90 days after brachytherapy Concurrent corticosteroids to improve quality of life allowed Radiotherapy No other radiotherapy prior to, during, or within 90 days after brachytherapy Surgery See Disease Characteristics No radiosurgery prior to, during, or within 90 days after brachytherapy Other No other investigational agents directed at the brain tumor prior to, during, or within 90 days after brachytherapy Concurrent noncytotoxic therapy to improve quality of life allowed

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
  • University of Texas Health Science Center at San Antonio

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 27, 2003
Last Updated
February 6, 2009
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00053183
Brief Title
Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Official Title
Phase I Brachytherapy Dose Escalation Using The GliaSite RTS In Newly Diagnosed Glioblastoma Multiforme In Conjunction With External Beam Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2004
Overall Recruitment Status
Completed
Study Start Date
October 2003 (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: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Combining internal radiation with external-beam radiation therapy may kill any remaining tumor cells following surgery. PURPOSE: Phase I trial to study the effectiveness of combining internal radiation therapy with external-beam radiation therapy in treating patients who have undergone surgery for glioblastoma multiforme.
Detailed Description
OBJECTIVES: Determine the maximum tolerated dose of brachytherapy administered via GliaSite RTS™ applicator followed by external beam radiotherapy in patients with newly diagnosed glioblastoma multiforme. Determine the acute and chronic toxicity of brachytherapy administered via GliaSite RTS™ in these patients. Determine the survival rate of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of brachytherapy. Patients undergo craniotomy for histologic confirmation of glioblastoma multiforme, surgical resection, and placement of a GliaSite RTS™ applicator that includes Iotrex™. Beginning 3-21 days after surgery, patients undergo brachytherapy via the GliaSite RTS™ applicator. Within 30 days of brachytherapy (no more than 60 days after resection) patients undergo external beam radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. 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 5 or 3 of 10 patients experience dose-limiting toxicity. Patients are followed at 21-35 days, every 2 months for 1 year, and then for survival. PROJECTED ACCRUAL: A total of 15-100 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 glioblastoma, 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)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Clinically suspected supratentorial grade IV glioblastoma multiforme Candidate for maximal surgical resection of tumor mass Expected residual enhancing tumor must be within the expected brachytherapy treatment volume Resection must not be expected to result in a new permanent neurologic deficit No clearly multi-focal disease (2 or more separate foci of contrast-enhancing tumor not all within the expected brachytherapy prescription volume by MRI) No enhancing tumor greater than 1 cm beyond the midline by MRI No grossly or radiographically apparent leptomeningeal spread and/or ventricular invasion outside the anticipated radiation treatment volume No marked edema by MRI with significant shift that is not anticipated to be corrected by resection 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 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Mini mental state exam score at least 15 No other concurrent medical illness that would preclude study participation No concurrent serious infection No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No immunotherapy prior to, during, or within 90 days after brachytherapy No biologic therapy with any of the following prior to, during, or within 90 days after brachytherapy : Immunotoxins Immunoconjugates Antiangiogenesis compounds Peptide receptor antagonists Interferons Interleukins Tumor-infiltrating lymphocytes Lymphokine-activated killer cells Gene therapy Antisense agents Chemotherapy No chemotherapy or polifeprosan 20 with carmustine implant (Gliadel wafers) prior to, during, or within 90 days after brachytherapy Endocrine therapy No hormonal therapy prior to, during, or within 90 days after brachytherapy Concurrent corticosteroids to improve quality of life allowed Radiotherapy No other radiotherapy prior to, during, or within 90 days after brachytherapy Surgery See Disease Characteristics No radiosurgery prior to, during, or within 90 days after brachytherapy Other No other investigational agents directed at the brain tumor prior to, during, or within 90 days after brachytherapy Concurrent noncytotoxic therapy to improve quality of life allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volker W. Stieber, MD
Organizational Affiliation
Wake Forest University Health Sciences
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
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
27157-1082
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
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7811
Country
United States

12. IPD Sharing Statement

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Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

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