NCT01095094

Ritonavir and Lopinavir in Treating Patients With Progressive or Recurrent High-Grade Glioma

Phase II Trial of Ritonavir/Lopinavir in Patients With Progressive of Recurrent High-Grade Gliomas

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Ritonavir and lopinavir may stop the growth of gliomas by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well giving ritonavir together with lopinavir works in treating patients with progressive or recurrent high-grade glioma.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the 6-month progression-free survival in patients with recurrent or progressive high grade gliomas treated with ritonavir and lopinavir. SECONDARY OBJECTIVES: I. To evaluate the toxicity of ritonavir and lopinavir in this patient population. OUTLINE: Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically.

Conditions

• Brain Tumor
• Anaplastic Astrocytoma
• Anaplastic Ependymoma
• Anaplastic Oligodendroglioma
• Brain Stem Glioma
• Giant Cell Glioblastoma
• Glioblastoma
• Gliosarcoma
• Mixed Glioma

Interventions

Type	Name	Description
DRUG	ritonavir	Given orally
DRUG	lopinavir	Given orally

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-06-01
• Completion: 2011-11-01
• First posted: 2010-03-29
• Last updated: 2013-06-10
• Results posted: 2013-06-10

Locations

1 site across 1 country: United States