A Phase III Multicenter Study of Intratumoral/Interstitial Therapy With TransMID™ Compared to Best Standard of Care in Patients With Progressive and/or Recurrent, Non-Resectable Glioblastoma Multiforme
This is a Multicenter, open label, randomized study comparing TransMID™ with a
chemotherapeutic regimen considered to be best standard of care and consisting of either
nitrosoureas, platinum compounds, temozolomide, procarbazine, PCV, (procarbazine, lomustine
(CCNU) & vincristine), CPT-11, or Etoposide. A planned interim analysis of the primary
efficacy endpoint will be conducted after approximately 50% of the required events have been
observed.
In order for a patient to be eligible for enrollment into this trial, he/she must be
diagnosed with glioblastoma multiforme which has been confirmed histologically and have
undergone conventional treatment, including surgery (biopsy or debulking) and/or radiation
therapy and/or chemotherapy, have a recurrent and/or progressive tumor ≥1.0 cm and ≤4.0 cm
in diameter.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival time i.e. to to death
United States: Food and Drug Administration
KSB311R/CIII/001
NCT00083447
May 2004
June 2007
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
New York Medical College | Valhalla, New York 10595 |
Cooper University Hospital | Camden, New Jersey 08103 |
Fairview University Medical Center | Minneapolis, Minnesota 55455 |
Temple University Hospital | Philadelphia, Pennsylvania 19140 |
University of Utah | Salt Lake City, Utah |
Medical College of Virginia | Richmond, Virginia 23298-0341 |
University of Colorado Health Sciences Center | Denver, Colorado 80262 |
Saint Louis University Hospital | St. Louis, Missouri 63110-0250 |
Yale University | New Haven, Connecticut 06520 |
University of Chicago | Chicago, Illinois 60637 |
University of Kentucky Medical Center | Lexington, Kentucky 40536-0093 |
Johns Hopkins Medical Center | Baltimore, Maryland |
University of Southern California | Los Angeles, California 90033 |
Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Columbia University Medical Center | New York, New York 10032 |
University of California-San Diego | La Jolla, California 92037-0698 |
University of Iowa Hospitals in Clinics | Cedar Rapids, Iowa 52242 |
NINDS National Institutes of Health | Bethesda, Maryland |
SUNY Upstate Medical University at Syracuse | Syracuse, New York 13210 |
University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599 |
Legacy Emanuel Hospital and Technology Center | Portland, Oregon 97227 |
Semmes-Murphey Neurologic Institute | Memphis, Tennessee 38104 |