drugset / Trial / NCT00412542

Thalidomide and Temozolomide or Camptothecin-11 (CPT-11) in Patients With Gliomas

NCT00412542 ↗

NaSingle-groupOpen-labelTreatment

Summary

Objectives: 1.1 To determine the efficacy, as measured by 6 month progression-free survival, of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent and/or progressive malignant gliomas. 1.2 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11. 1.3 To determine Thrombotic thrombocytopenic purpura (TTP), overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas. 1.4 To determine changes in dynamic magnetic resonance imaging (MRI) as a surrogate marker for treatment effect.

Timeline

Start
2003-10
Primary completion
2009-10
Completion
2009-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule 125 mg/m2 Intravenous
Subject Thalidomide Other / unclassified 100 mg Oral

Indications