drugset
drugset / Trial / NCT00441142

Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors

NCT00441142 ↗

Phase 1/2 Completed 119 enrolled Patrick Y. Wen, MD Beth Israel Deaconess Medical Center · collabDana-Farber Cancer Institute · collabHenry Ford Hospital · collabMassachusetts General Hospital · collabMemorial Sloan Kettering Cancer Center · collabUniversity of Virginia · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Phase I: The purpose of this research study is to determine the safety of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. We will determine the highest dose of ZD6474 (Vandetanib) that can be given safely when combined with temozolomide (Temodar) and radiation therapy. Phase II: The purpose of this research study is to determine the efficacy of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. All subjects participating in this research study must NOT be taking a certain type of anti-seizure medication called enzyme inducing anticonvulsant drugs. These drugs include (but are not limited to) the following medications: Dilantin, Tegretol, Phenobarbital and trileptal.

Timeline

Start
2007-05-25
Primary completion
2013-08-31
Completion
2017-10-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Vandetanib Small molecule 100 mg Oral
Background Temozolomide Small molecule 75 mg/m2 Oral
Background Temozolomide Small molecule 150 mg/m2 Oral
Background Temozolomide Small molecule 200 mg/m2 Oral

Indications

gliosarcoma