At a glance
ClinicalIndex Comparison Record- ✓Pathologic evidence of malignant glioma
- ✓Age 18–70
- ✓KPS >50
- ✓MGMT analysis tissue available
- ✕Any prior chemotherapy, radiotherapy, or biologic therapy for glioma
- ✕Prior experimental therapy for glioma
- ✕Other concurrent active malignancy (except cervical carcinoma in situ or basal cell carcinoma of skin)
- ✕Serious medical or psychiatric illness interfering with treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Trial of Concurrent Temozolomide and Radiotherapy Followed by Dose Dense Versus Metronomic Temozolomide and Maintenance Cis-Retinoic Acid for Patients With Newly Diagnosed Glioblastoma and Other Malignant Gliomas
In Brief
A Phase 2 clinical trial evaluating Temozolomide for Glioblastoma and Gliomas. Completed, enrolled 127 participants across 3 sites.
Detailed Summary
Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the study to see if it is possible to increase the benefit of temozolomide when given after radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide than patients treated with radiotherapy alone. Patients will receive standard low dose temozolomide during radiation. After radiation, they will be randomized to receive either more intense temozolomide or continuous low dose temozolomide.
Study Details
Timeline
Interventions
Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.
Focal RT 6000 cGy/ Temozolomide 75 mg/m2 plus Temozolomide 150 mg/m2 will be given to patients on days 1-7 and 15-21 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.