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Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

Primary Purpose

Brain and Central Nervous System Tumors

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bleomycin
Ommaya reservoir
radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
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: Histologically confirmed supratentorial glioblastoma multiforme (with areas of necrosis) by surgical biopsy or excision within 4 weeks of study Tumor and/or any associated edema limited to one hemisphere and unifocal No gross invasion of a ventricular surface Tumor accessible No other astrocytoma No multifocal or recurrent malignant glioma No disease below the tentorium or beyond the cranial vault PATIENT CHARACTERISTICS: Age: Adult Performance status: Zubrod 0-1 Life expectancy: At least 8 weeks Hematopoietic: Hemoglobin at least 10 g/dL (transfusion allowed) Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL Serum glutamic-oxaloacetic transaminase (SGOT) or Serum glutamic-pyruvic transaminase (SGPT) no greater than 2 times normal Renal: Blood Urea Nitrogen (BUN) no greater than 25 mg/dL Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No hypersensitive or idiosyncratic reaction to bleomycin No other prior malignancies within the past 2 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix or urinary bladder No other major medical illness or psychiatric impairment that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for glioblastoma multiforme No prior radiosensitizer for glioblastoma multiforme Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head or neck resulting in overlapping radiotherapy fields Surgery: See Disease Characteristics Recovered from prior surgery

Sites / Locations

  • Foundation for Cancer Research and Education
  • Markey Cancer Center at University of Kentucky Chandler Medical Center
  • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
  • South Jersey Regional Cancer Center
  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
  • Cancer Treatment Center
  • St. John Health System
  • Cottonwood Hospital Medical Center
  • Utah Valley Regional Medical Center - Provo
  • Dixie Regional Medical Center
  • LDS Hospital
  • CCOP - Marshfield Clinic Research Foundation
  • Medical College of Wisconsin Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiation therapy followed by bleomycin via Ommaya reservoir

Arm Description

60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.

Outcomes

Primary Outcome Measures

Overall Survival
This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.

Secondary Outcome Measures

Full Information

First Posted
December 6, 2000
Last Updated
October 21, 2020
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006916
Brief Title
Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
Official Title
A Phase II Trial Of Conventional Radiation Therapy Followed By Intratumoral Bleomycin Delivered Using A Refillable, Sustained Release Device (IND# 46,592) For The Treatment Of Supratentorial Glioblastoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
June 2001 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by bleomycin in treating adult patients who have newly diagnosed supratentorial glioblastoma multiforme.
Detailed Description
OBJECTIVES: Determine the median survival time of patients with newly diagnosed supratentorial glioblastoma multiforme treated with radiotherapy followed by sustained release intratumoral bleomycin. Determine the feasibility of this regimen in these patients. OUTLINE: This is a multicenter study. Within 4 weeks after surgical resection, patients receive radiotherapy daily 5 days a week for 6 weeks. Within 2-6 weeks after completion of radiotherapy or at disease progression during radiotherapy, patients undergo surgical implantation of a modified Ommaya reservoir within the central area of the tumor. Patients then receive sustained release bleomycin intratumorally via the reservoir once a week for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 5 months.

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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiation therapy followed by bleomycin via Ommaya reservoir
Arm Type
Experimental
Arm Description
60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
Intervention Type
Biological
Intervention Name(s)
bleomycin
Intervention Type
Device
Intervention Name(s)
Ommaya reservoir
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
60.0 Gy/30 fractions x 2.0 Gy. For the first 46 Gy/23 fractions the treatment volume should include the volume of contrast-enhancing lesion and surrounding edema on pre-operative CT/MRI scan plus a 2 centimeter margin. If no edema is present, the margin should be 2.5 cm. After 46.0 Gy, the tumor volume should include the contrast-enhancing lesion (without edema) on the pre-surgery MRI/CT scan plus a 2.5 centimeter margin.
Primary Outcome Measure Information:
Title
Overall Survival
Description
This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.
Time Frame
From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial glioblastoma multiforme (with areas of necrosis) by surgical biopsy or excision within 4 weeks of study Tumor and/or any associated edema limited to one hemisphere and unifocal No gross invasion of a ventricular surface Tumor accessible No other astrocytoma No multifocal or recurrent malignant glioma No disease below the tentorium or beyond the cranial vault PATIENT CHARACTERISTICS: Age: Adult Performance status: Zubrod 0-1 Life expectancy: At least 8 weeks Hematopoietic: Hemoglobin at least 10 g/dL (transfusion allowed) Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL Serum glutamic-oxaloacetic transaminase (SGOT) or Serum glutamic-pyruvic transaminase (SGPT) no greater than 2 times normal Renal: Blood Urea Nitrogen (BUN) no greater than 25 mg/dL Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No hypersensitive or idiosyncratic reaction to bleomycin No other prior malignancies within the past 2 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix or urinary bladder No other major medical illness or psychiatric impairment that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for glioblastoma multiforme No prior radiosensitizer for glioblastoma multiforme Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head or neck resulting in overlapping radiotherapy fields Surgery: See Disease Characteristics Recovered from prior surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy A. Patchell, MD
Organizational Affiliation
Lucille P. Markey Cancer Center at University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foundation for Cancer Research and Education
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Markey Cancer Center at University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0293
Country
United States
Facility Name
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-4199
Country
United States
Facility Name
South Jersey Regional Cancer Center
City
Millville
State/Province
New Jersey
ZIP/Postal Code
08332
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Cancer Treatment Center
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
St. John Health System
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Cottonwood Hospital Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Utah Valley Regional Medical Center - Provo
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Dixie Regional Medical Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme

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