Study:
Phase I/II Study of the Poly (ADP-Ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant Glioma
Rationale:
BSI-201 may stop the growth of tumor cells by blocking some of the enzymes needed
for cell growth. 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 kill tumor cells. Giving BSI-201
together with temozolomide and radiation therapy may kill more tumor cells.
Purpose:
This phase I/II trial is studying the side effects and best dose of BSI-201 when
given together with temozolomide with or without radiation therapy and to see how well it
works in treating patients with newly diagnosed malignant glioma.
Study Status: Recruiting
Recruiting:
Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100
| Condition |
Intervention |
Phase |
|
Brain and Central Nervous System Tumors |
Drug: BSI-201
Drug: temozolomide
Procedure: 3-dimensional conformal radiation therapy
Procedure: intensity-modulated radiation therapy |
Phase 1/Phase 2 |
Verified by
National Cancer Institute (NCI)
April, 2008
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00589576
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Jaishri O. Blakeley, MD., Study Chair
Stuart A. Grossman, MD.,