Comparison of TransMID vs Standard Treatment of Cancerous Brain Tumors
Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
Participant gender:
Summary
Study Objectives:
Primary Objective:
To evaluate the efficacy of intratumoral/interstitial therapy with TransMID compared to best
standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma
multiforme.
Secondary Objectives:
To assess the safety of intratumoral/interstitial therapy with TransMID compared to best
standard of care in patients with progressive and/or recurrent, non-resectable glioblastoma
multiforme.
To evaluate possible differences in efficacy and/or safety with TransMID associated with
differing degrees of transferrin receptor expression in tumor tissue and serum
anti-diphtheria toxin antibody titer levels.
Study Design:
Multicenter, open label, randomized study comparing TransMID with a chemotherapeutic regimen
considered to be best standard of care and consisting of either nitrosureas, platinum
compounds, temozolomide, procarbazine or PCV (procarbazine, lomustine (CCNU) & vincristine).
A planned interim analysis of the primary efficacy endpoint will be conducted after
approximately 50 percent of the required events have been observed.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)