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RTOG 0013 Protocol Information

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A Phase II Trial of Conventional Radiation Therapy followed by Intratumoral Bleomycin Delivered using a Refillable Sustained Device (IND#46,592) for the Treatment of Supratentorial Glioblastoma
Protocol Documents
Current Version Date: 6/6/2001
Principal Investigator: Roy A. Patchell, M.D.
Primary Objective:

To determine if bleomycin given intratumorally weekly after conventional RT will improve the median survival time of adults with newly diagnosed supratentorial glioblastoma.

Patient Population:

Histopathologically confirmed glioblastoma multiforme (with areas of necrosis);

The tumor must be supratentorial in location, unifocal and limited to one hemisphere without gross invasion of a ventricular surface;

The tumor must be in a location that can be reached by the drug delivery catheter attached to the Ommaya device as judged by a neurosurgeon;

Therapy must begin  </=  4 weeks after surgery;

Estimated survival of at least 8 weeks;

Zubrod 0-1;

Absolute neutrophil count >/=1500, platelets >/=100,000, BUN </=25, Creatinine </=1.5, Bilirubin </= 2.0, Hgb >/= 10 gm, SGPT or SGOT  </=  2 x normal range;

No recurrent or multifocal malignant gliomas;

No major medical illnesses or psychiatric impairments;

No malignancy (within the past two years) except non-melanomatous skin cancer or carcinoma in-situ of the cervix;

No prior radiation therapy to head or neck area that would result in “overlap” of radiation fields;

No prior chemotherapy or radiosensitizer treatment for this brain tumor
Target Accrual: 72
Current Accrual: 19
Status: Terminated
Date: 2/19/2009
Participating Sites:
Arizona Oncology Services Foundation Scottsdale AZ
Centre Hospitalier de l`Universite de Montreal-Notre Dame Montreal Quebec
Cottonwood Hospital Medical Center Murray UT
Dixie Medical Center Regional Cancer Center East St. George UT
Einstein Medical Center Philadelphia Philadelphia PA
Froedtert and the Medical College of Wisconsin Milwaukee WI
Gundersen Lutheran Medical Center La Crosse WI
Indiana University Health Ball Memorial Hospital, Inc. Muncie IN
Inspira Medical Center Vineland Vineland NJ
Kansas City CCOP Prairie Village KS
Kentucky Clinic Berea Berea KY
LDS Hospital Salt Lake City UT
Liberty Hospital Liberty MO
McGill University Department of Oncology Montreal
McKay-Dee Hospital Center Ogden UT
Methodist Cancer Center Omaha NE
Methodist Medical Center of Illinois Peoria IL
Mobile Infirmary Medical Center Mobile AL
New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn NY
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield Springfield MO
ProHealth Waukesha Memorial Hospital Waukesha WI
Roswell Park Cancer Institute Buffalo NY
Saint Claire Regional Medical Center Morehead KY
Saint John Medical Center Tulsa OK
Saint Louis University Hospital St. Louis MO
Southeast Cancer Control Consortium CCOP Winston Salem NC
St Joseph's Hospital Medical Center Stockton CA
Tallahassee Memorial HealthCare Tallahassee FL
University of Kentucky/Markey Cancer Center Lexington KY
University of Maryland/Greenebaum Cancer Center Baltimore MD
University of Wisconsin Hospital and Clinics Madison WI
Upstate Carolina CCOP Spartanburg SC
Utah Valley Regional Medical Center Provo UT
Veteran's Administration Medical Center - Lexington Lexington KY
Virtua Memorial Mount Holly NJ
Updated: 4/6/2011

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