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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00006916
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Radiation Therapy Oncology Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Roy A. Patchell, MD
Principal Investigator Affiliation Lucille P. Markey Cancer Center at University of Kentucky
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors
Additional Details

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.

Arms & Interventions

Arms

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Address

Foundation for Cancer Research and Education

Phoenix, Arizona, 85013

Lexington, Kentucky

Status

Address

Markey Cancer Center at University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536-0293

Omaha, Nebraska

Status

Address

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha

Omaha, Nebraska, 68114-4199

South Jersey Regional Cancer Center, Millville, New Jersey

Status

Address

South Jersey Regional Cancer Center

Millville, New Jersey, 08332

Mount Holly, New Jersey

Status

Address

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital

Mount Holly, New Jersey, 08060

Cancer Treatment Center, Wooster, Ohio

Status

Address

Cancer Treatment Center

Wooster, Ohio, 44691

St. John Health System, Tulsa, Oklahoma

Status

Address

St. John Health System

Tulsa, Oklahoma, 74104

Cottonwood Hospital Medical Center, Murray, Utah

Status

Address

Cottonwood Hospital Medical Center

Murray, Utah, 84107

Provo, Utah

Status

Address

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604

Dixie Regional Medical Center, Saint George, Utah

Status

Address

Dixie Regional Medical Center

Saint George, Utah, 84770

LDS Hospital, Salt Lake City, Utah

Status

Address

LDS Hospital

Salt Lake City, Utah, 84143

Marshfield, Wisconsin

Status

Address

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449

Milwaukee, Wisconsin

Status

Address

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226