Dietary Methionine Restriction Plus Temozolomide for Recurrent GBM
Status:
Terminated
Trial end date:
2008-11-01
Target enrollment:
Participant gender:
Summary
Objectives:
1. To determine the safety, tolerability and efficacy of dietary methionine restriction for
7 days alternating with Temodar® (Temozolomide) given once a day for seven days and this
repeated for up to one year in the treatment of patients with recurrent and/or
progressive glioblastoma.
2. To determine the short- and long-term toxicity of dietary methionine restriction
combined with Temodar® in glioblastoma patients.
3. To measure and correlate patients' tumor responses and progression-free survival with:
serum methionine and peripheral blood lymphocyte methylation levels. In any patient
undergoing surgery, to measure tumor alkylguanyl transferase (AGT) and methionine levels
and compare to control specimens.