Clinical trial NCT01095094: Ritonavir and Lopinavir in Treating Patients With Progressive or Recurrent High-Grade Glioma
Official title: Phase II Trial of Ritonavir/Lopinavir in Patients With Progressive of Recurrent High-Grade Gliomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Brain Tumor
Anaplastic Astrocytoma
Anaplastic Ependymoma
Anaplastic Oligodendroglioma
Brain Stem Glioma
Giant Cell Glioblastoma
Glioblastoma
Gliosarcoma
Mixed Glioma
Keywords: adult brain tumor
adult anaplastic astrocytoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
adult brain stem glioma
adult giant cell glioblastoma
adult glioblastoma
adult gliosarcoma
adult mixed glioma
recurrent adult brain tumor
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2010-03-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Progression-free Survival
timeFrame: At 6 months
Secondary outcomes:
measure: Grade 3-5 Toxicity as Assessed by NCI CTC v3.0
timeFrame: at 6 months from start of treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: David Peereboom, MD
role: PRINCIPAL_INVESTIGATOR
References: