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TERMINATEDPHASE2

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

NCT01095094•Case Comprehensive Cancer Center

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically proven high grade glioma (WHO grade 3-4) which is progressive or recurrent following radiation therapy with or without chemotherapy
•Patients with previous low grade glioma who progressed after radiotherapy and chemotherapy and are biopsied and found to have a high grade glioma are eligible
•Patients must have recovered from toxicity of prior therapy - An interval of \>= 3 months must have elapsed since the completion of the most recent course of radiation therapy
•Minimum interval since last drug therapy: 2 weeks since last non-cytotoxic therapy; 3 weeks must have elapsed since the completion of a non-nitrosourea containing chemotherapy regimen; 6 weeks since the completion of a nitrosourea containing chemotherapy regimen
•Patients must have a Karnofsky performance status \>= 60% (i.e., must be able to care for himself/herself with the occasional help of others)
•Patients must have normal hematologic, renal, and liver function (i.e., absolute neutrophil count \>= 1500/mm\^3, platelets \>= 100,000/mm\^3, HgB \> 9 d/dl, creatinine =\< 1.5mg/dl, total bilirubin =\< 1.5mg/dl, transaminases =\< 2.5 times the upper limits of the institutional norm)
•Patients must be able to provide written informed consent
•Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid contraception - Female patients of child-bearing potential must have a negative pregnancy test
•Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin of carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission
•Patients with other prior malignancies must be disease-free for \>= 3 years
+2 more criteria

Exclusion Criteria

•Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlines in this protocol with reasonable safety
•Patients who are pregnant or breast-feeding
•Patients receiving concurrent therapy for their tumor (with the exception of steroids)
•HIV positive
•Prior therapy with HIV protease inhibitors
•Concurrent therapy with hepatic enzyme inducing anticonvulsant
•Inability to be followed closely at the Cleveland Clinic
•Patients requiring the use of medication well-known contraindicated for concomitant use with lopinavir/ritonavir: amiodarone, astemizole, bepridil, bupropione, cisapride, clorazepate, clozapim, diazepam, encainide, flecainide, flurazepam, meperidine, midazolam, primozide, piroxicam, propafenone, propoxifeno, quinidine, rifabutin, terfenadine, triazolam, zolpidem, dihydroergotamine, ergotamine

Locations (1)

Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Key Dates

Start Date

January 1, 2009

Primary Completion Date

June 1, 2010

Completion Date

November 1, 2011

Last Updated

June 10, 2013

Enrollment

ACTUAL participants

Conditions

Brain TumorAnaplastic AstrocytomaAnaplastic EpendymomaAnaplastic OligodendrogliomaBrain Stem GliomaGiant Cell GlioblastomaGlioblastomaGliosarcomaMixed Glioma

Interventions

ritonavir

DRUG

lopinavir

DRUG

Targeted Pediatric High-Grade Glioma Therapy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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