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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Case Comprehensive Cancer Center

Current Primary Outcome: Progression-free Survival [ Time Frame: At 6 months ]

Number of patients that remained disease free at 6 months from start of treatment.


Original Primary Outcome: Progression-free Survival [ Time Frame: At 6 months ]

Current Secondary Outcome: Grade 3-5 Toxicity as Assessed by NCI CTC v3.0 [ Time Frame: at 6 months from start of treatment ]

Number of participants with adverse events grades 3-5. For a detailed list of adverse events see the adverse event module.


Original Secondary Outcome: Toxicity as assessed by NCI CTC v3.0 [ Time Frame: monthly during first year, q 3 months during second year, then q 4 months yearly ]

Information By: Case Comprehensive Cancer Center

Dates:
Date Received: March 26, 2010
Date Started: January 2009
Date Completion:
Last Updated: April 24, 2013
Last Verified: April 2013