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

October 21, 2020 updated by: Radiation Therapy Oncology Group

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Foundation for Cancer Research and Education
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0293
        • Markey Cancer Center at University of Kentucky Chandler Medical Center
    • Nebraska
      • Omaha, Nebraska, United States, 68114-4199
        • Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
    • New Jersey
      • Millville, New Jersey, United States, 08332
        • South Jersey Regional Cancer Center
      • Mount Holly, New Jersey, United States, 08060
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
    • Ohio
      • Wooster, Ohio, United States, 44691
        • Cancer Treatment Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • St. John Health System
    • Utah
      • Murray, Utah, United States, 84107
        • Cottonwood Hospital Medical Center
      • Provo, Utah, United States, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, United States, 84770
        • Dixie Regional Medical Center
      • Salt Lake City, Utah, United States, 84143
        • LDS Hospital
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • CCOP - Marshfield Clinic Research Foundation
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiation therapy followed by bleomycin via Ommaya reservoir
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.
Biological: bleomycin
Device: Ommaya reservoir
Radiation: radiation therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.
This study stopped accrual early with 19 subjects accrued out of 72 planned therefore no analyses were performed.
From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Roy A. Patchell, MD, Lucille P. Markey Cancer Center at University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2001

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

December 6, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 21, 2020

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG-BR-0013
  • CDR0000068343

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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