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

Phase 2

Terminated

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00006916
• Lead Sponsor: Radiation Therapy Oncology Group

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.

Study Timeline

• Study First Submitted: 2000-12-06
• Study Start: 2001-06
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Results First Submitted: 2013-06-12
• Results First Submitted QC: 2013-12-10
• Results First Posted: 2014-02-03
• Status Verified: 2015-11
• Last Update Submitted: 2020-10-21
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall Survival	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.

Trial Locations

Locations (13)

Foundation for Cancer Research and Education; 🇺🇸 Phoenix, Arizona, United States

Markey Cancer Center at University of Kentucky Chandler Medical Center; 🇺🇸 Lexington, Kentucky, United States

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha; 🇺🇸 Omaha, Nebraska, United States

South Jersey Regional Cancer Center; 🇺🇸 Millville, New Jersey, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital; 🇺🇸 Mount Holly, New Jersey, United States

Cancer Treatment Center; 🇺🇸 Wooster, Ohio, United States

St. John Health System; 🇺🇸 Tulsa, Oklahoma, United States

Cottonwood Hospital Medical Center; 🇺🇸 Murray, Utah, United States

Utah Valley Regional Medical Center - Provo; 🇺🇸 Provo, Utah, United States

Dixie Regional Medical Center; 🇺🇸 Saint George, Utah, United States

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