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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01095094
• Date of registration: 26/03/2010
• Primary sponsor: Case Comprehensive Cancer Center
• Public title: Ritonavir and Lopinavir in Treating Patients With Progressive or Recurrent High-Grade Glioma
• Scientific title: Phase II Trial of Ritonavir/Lopinavir in Patients With Progressive of Recurrent High-Grade Gliomas
• Date of first enrolment: January 2009
• Target sample size: 19
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01095094
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: David Peereboom, MD
• Affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Key inclusion & exclusion criteria

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

- Patients must be maintained on a stable corticosteroid regimen from the time of their
baseline scan until the start of treatment

- Patients must have a Mini mental state exam score >= 15

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Anaplastic Astrocytoma

Anaplastic Ependymoma

Anaplastic Oligodendroglioma

Brain Stem Glioma

Brain Tumor

Giant Cell Glioblastoma

Glioblastoma

Gliosarcoma

Mixed Glioma

Intervention(s)

Drug: lopinavir

Drug: ritonavir

Primary Outcome(s)

Progression-free survival [Time Frame: At 6 months]

Secondary Outcome(s)

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]

Secondary ID(s)

CASE2307

NCI-2009-01288

Source(s) of Monetary Support

Please refer to primary and secondary sponsors