GBM dasatinib study

Full Name

Brain Tumor (NCCTG N0877): Phase I/ randomized phase II trial of either dasatinib or placebo combined with standard chemo-radiotherapy for newly diagnosed glioblastoma multiforme (GBM) (1_PRO00000372)

Description

Participants will be randomized to one of two groups: 1) treatment by placebo plus standard of care radiation therapy with temozolomide for 6 weeks, followed by 4-6 weeks rest period, followed by temozolomide for 1 year, followed by indefinite use of placebo; or 2) treatment by study drug plus standard of care radiation therapy for 6 weeks, followed by 4-6 weeks rest period, followed by study drug plus temozolomide for 1 year, followed by indefinite use of the study drug The participants will be in the study as long as their disease does not get worse, or until they have side effects that are unacceptable. They will be assessed every 6 months (even if they stop taking the study drug) for up to 5 years from the time they entered the study.

Eligibility

Inclusion Criteria

o Must be greater than or equal to 18 years of age
o Appropriate performance scores
o Histological confirmation of newly diagnosed GBM
o Cannot be pregnant or breastfeeding, must consent to pregnancy test
o Must use adequate contraception for study duration, and for 4 weeks after study drug is stopped
o Cannot eat or drink the juice of grapefruits during study
o Must provide informed consent and be willing to return for follow-up
o Must be able to swallow pills
o No prior radiotherapy or chemotherapy for any CNS neoplasm