Ritonavir and Lopinavir in Treating Patients With Progressive or Recurrent High-Grade Glioma
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|ClinicalTrials.gov Identifier: NCT01095094|
Recruitment Status : Terminated (Study did not meet its primary objective)
First Posted : March 29, 2010
Results First Posted : June 10, 2013
Last Update Posted : June 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor Anaplastic Astrocytoma Anaplastic Ependymoma Anaplastic Oligodendroglioma Brain Stem Glioma Giant Cell Glioblastoma Glioblastoma Gliosarcoma Mixed Glioma||Drug: ritonavir Drug: lopinavir||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Ritonavir/Lopinavir in Patients With Progressive of Recurrent High-Grade Gliomas|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||November 2011|
Experimental: Arm I
Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
Other Name: ABT-378/r
- Progression-free Survival [ Time Frame: At 6 months ]Number of patients that remained disease free at 6 months from start of treatment.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095094
|United States, Ohio|
|Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||David Peereboom, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|