Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I/Randomized Phase II Trial of Either Dasatinib or Placebo Combined With Standard Chemo-Radiotherapy for Newly Diagnosed Glioblastoma Multiforme (GBM)
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also make tumor cells more sensitive to radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. This randomized phase I/II trial is studying the best dose of dasatinib and to see how well it works compared with a placebo when given together with radiation therapy and temozolomide in treating patients with newly diagnosed glioblastoma multiforme.
This trial includes a phase I dose-escalation study and a double-blind randomized phase II
trial for patients with newly diagnosed glioblastoma multiforme (GBM). Phase I will be a
cohort of 3 dose-escalation trial of dasatinib in combination with radiation and concomitant
temozolomide. Patients receive concomitant chemotherapy and radiation therapy for cycle one.
Patients receive adjuvant chemotherapy 28-42 days post cycle one treatment. Patients receive
only dasatinib post cycle 8 treatment until progressive disease, unacceptable adverse events
or refusal.
Phase II will be a randomized trial with two treatment arms. Patients will be randomized at
the time of registration at a ratio of 1:2 respectively to either standard therapy arm
(continuous daily placebo prior, during and after standard radiotherapy/temozolomide followed
by temozolomide. For more information please see the Arms section. The primary objectives are
listed below.
Primary Objectives:
1. To establish a maximum tolerated dose of dasatinib combined with radiation and
temozolomide in this patient population (Phase I)
2. To determine the efficacy of dasatinib in combination with radiotherapy and concomitant
and adjuvant temozolomide in patients with newly diagnosed glioblastoma, and compare it
with the standard of care approach in the treatment of these patients consisting of
radiotherapy and temozolomide, followed by adjuvant temozolomide (Phase II)
Patients are followed for 5 years post treatment. The study permanently closed to accrual on
January 31, 2014.
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