Radiation Therapy Followed by Bleomycin in Treating Adult Patients With Newly Diagnosed Supratentorial Glioblastoma Multiforme
NCT ID: NCT00006916
Last Updated: 2020-10-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
19 participants
INTERVENTIONAL
2001-06-30
2005-12-31
Brief Summary
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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
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
bleomycin
Ommaya reservoir
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.
Interventions
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bleomycin
Ommaya reservoir
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Roy A. Patchell, MD
Role: PRINCIPAL_INVESTIGATOR
Lucille P. Markey Cancer Center at University of Kentucky
Locations
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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
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CDR0000068343
Identifier Type: -
Identifier Source: secondary_id
RTOG-BR-0013
Identifier Type: -
Identifier Source: org_study_id