Clinical Trial DRUG PLX108-08
- An Open Label Phase 1b/2 Study of Orally Administered PLX3397 in Combination with Radiation Therapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma
- Principal Investigator
- Jeffrey Raizer
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG PLX108-08
- The purpose of this research study is to assess the safety and efficacy of PLX3397 (the study drug) in people diagnosed with a type of brain cancer called gliblastoma multiforme (GBM).
- This study is for patients who have been diagnosed with GMB. GBM is the most frequent type of brain tumor, accounting for about 12% to 15% of all brain tumors. In this is a study research are looking at an experimental study drug, PLX3397, for the treatment of GBM. “Experimental” means that the study drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA).
Some of the eligibility criteria include:
- Participants must have a diagnosis of GBM or gliosarcoma.
- Participants must have had surgery to remove all or part of the cancer within 5 weeks of starting the study.
- Participants must be 18 or older.
- Description of Treatment
- All study participants will take capsules of the study drug by mouth twice a day. After taking study drug twice a day for the first 7 days, participants will begin radiation therapy on day 8 and continue once a day 5 times per week for 6 weeks. Participants will continue to take study drug twice a day while being given radiation therapy. In addition to study drug and radiation therapy, participants will also receive another drug, Temozolomide. It is a capsule taken by mouth taken once a day for 42 days (6 weeks) beginning on day 8 (same day as beginning radiation therapy). Then, after a 28-day break, it may be taken once a day for 5 days in a row, followed by a 23-day break before repeating the next dosage cycle. The doctor will decide how many times participants should repeat the treatment cycles.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
Find Related Clinical Trials
Browse by Disease Sites
Other Clinical Trials by Jeffrey Raizer
- A Phase II Randomized Trial Comparing the Efficacy of Heat Shock Protein-Peptide Complex-96 (HSPPC-96)(NSC #725085, Alliance IND#15380) Vaccine Given with Bevacizumab Versus Bevacizumab Alone in the Treatment of Surgically Resectable Recurrent Glioblastoma Multiforme (GBM)
- A Phase 2, Multicenter, Open-Label Study Of BGJ398 in Patients with Recurrent Resectable or Unresectable Glioblastoma
- Phase Ib/II multicenter study of buparlisib plus carboplatin or lomustine in patients with recurrent glioblastoma multiforme (GBM)
- A Phase 1/2 Study of SL-701, a Subcutaneously Injected Multivalent Glioma-Associated Antigen Vaccine, in Adult Patients with Recurrent Glioblastoma Multiforme
- Phase I/II Dose Escalation Trial to Assess Safety of Intrathecal Trastuzumab for the Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer
- A Phase II Study of the Efficacy of Hypofractionated Radiation Therapy with Bevacizumab and Temozolomide Followed by Maintenance Temozolomide and Bevacizumab for Recurrent High-Grade Gliomas
- A Phase I-II trial Everolimus and Sorafenib in Patients with Recurrent High-Grade Gliomas BTTC09-01
- Phase I/II Adaptive Randomized Trial of Bevacizumab versus Bevacizumab plus Vorinostat in Adults with Recurrent Glioblastoma (BTTC11-02)
- A Phase II Trial of Oral Pazopanib plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) without Prior Bevacizumab Exposure and (B) after Failing Prior Bevacizumab
- Phase II Randomized Study of Rituximab, Methotrexate, Procarbazine, Vincristine & Cytarabine with and without Low-Dose Whole-Brain Radiotherapy for Primary Central Nervous System Lymphoma
- Randomized Phase II of Concurrent Bevacizumab & Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma
last updated: 28-Jan-15 06:15 PM
Clinical trial availability changes frequently. Please check this site often for updates or call 312.695.1102 for personal assistance.