Study:
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
Rationale:
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.
Purpose:
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 Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma |
Drug: cilengitide
Drug: temozolomide
Radiation: radiation therapy
Other: laboratory biomarker analysis
Other: pharmacological study |
Phase 1/Phase 2 |
Verified by
National Cancer Institute (NCI)
April, 2013
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00085254
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Louis Nabors., Principal Investigator