At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
- ✓No prior radiation therapy, chemotherapy, immunotherapy, or biologic agents for brain tumor; glucocorticoid therapy allowed
- ✓Recovered from immediate post-operative period and maintained on stable corticosteroid regimen (no increase for 5 days) prior to treatment start
- ✓Mini Mental State Exam score ≥15
- ✕Serious concurrent infection or medical illness jeopardizing safe treatment
- ✕Pregnant or breast-feeding
- ✕Concurrent therapy for tumor (chemotherapeutics or investigational agents)
- ✕Prior or concurrent malignancy, except curatively treated carcinoma-in-situ or basal cell carcinoma, or disease-free ≥5 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Safety Run-in/Randomized Phase II Trial of EMD 121974 in Conjunction With Concomitant and Adjuvant Temozolomide With Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme
In Brief
A Phase 2 clinical trial evaluating cilengitide, temozolomide, and 3 other interventions for Adult Giant Cell Glioblastoma and 2 related conditions. Completed, enrolled 112 participants across 8 sites.
Detailed Summary
Cilengitide may stop the growth of cancer by stopping blood flow to the tumor. 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving cilengitide together with temozolomide and radiation therapy may kill more tumor cells. This randomized phase I/II trial is studying the side effects and best dose of cilengitide when given together with temozolomide and radiation therapy and to compare how well they work in treating patients with newly diagnosed glioblastoma multiforme
Study Details
Timeline
Interventions
Given IV
Given orally
Undergo radiotherapy
Correlative studies
Correlative studies