MGd Phase II Trial in Glioblastoma -- RTOG-0513
Enrollment is closed for this study; ongoing patients are being evaluated.
Official Title
RTOG-0513: A Phase I/II Trial of Temozolomide, Motexafin Gadolinium, and 60 GY Fractionated Radiation for Newly Diagnosed Supratentorial Glioblastoma Multiforme
Purpose
This trial is studying the side-effects and best dose of motexafin gadolinium (MGd) when given together with temozolomide and radiation therapy and to evaluate the effects of the treatment regimen on overall and progression-free survival of patients with newly diagnosed supratentorial glioblastoma multiforme (GBM).
Study Design
This is a multicenter, dose-escalation study in 2 phases. In both phases, patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. They receive oral temozolomide once daily prior to radiotherapy on days 0-39, and they also receive intravenous MGd once daily prior to radiotherapy on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily for 5 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. In Phase 1, cohorts of 3-6 patients receive escalating doses of MGd until the maximum tolerated dose (MTD) is determined. Phase 2 patients undergo radiotherapy and receive temozolomide as in Phase 1; they also receive MGd as in Phase 1, at the MTD determined in Phase 1.
After completion of study treatment, patients are followed every 2 months for 1 year, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Eligibility
To be included in the study, patients must meet the following general criteria:
- At least 18 years of age
- Newly diagnosed (by surgical biopsy or excision within the past 5 weeks), histologically confirmed GBM of supratentorial location
- No prior systemic chemotherapy for the current GBM
- No other concurrent chemotherapy
- No prior radiotherapy to the head and neck (except for T1 glottic cancer) that would result in overlap of radiation therapy fields
- No prior invasive malignancies, except for nonmelanomatous skin cancer and carcinoma in situ of the uterine cervix or bladder, unless disease-free for ≥ 3 years
- No medical conditions that would increase risks of MGd treatment
For more details about this study, please refer to information posted at: http://www.clinicaltrials.gov/ct/show/NCT00305864?order=3 or contact Radiation Therapy Oncology Group Protocol Co-Chair by email at lashby@chw.edu or at 602-406-6208; 800-227-7691