Comparison of TransMID vs Standard Treatment of Cancerous Brain Tumors

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.

Timeline

Start

2004-07

Primary completion

—

Completion

2005-11

Publications

• Background Ameri A, Poisson M, Chen QM, Delattre JY. Treatment of recurrent malignant supratentorial gliomas with the association of procarbazine, thiotepa and vincristine: a phase II study. J Neurooncol. 1993 Jul;17(1):43-6. doi: 10.1007/BF01054273.
• Background Angelova-Gateva P. Iron transferrin receptors in rat and human cerebrum. Agressologie. 1980;21(1):27-30. No abstract available.
• Background Bobo RH, Laske DW, Akbasak A, Morrison PF, Dedrick RL, Oldfield EH. Convection-enhanced delivery of macromolecules in the brain. Proc Natl Acad Sci U S A. 1994 Mar 15;91(6):2076-80. doi: 10.1073/pnas.91.6.2076.

Drugs

Indications