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

NCT01095094 | Terminated Phase 2 Results DMC

• 2 other identifiers: CASE2307NCI-2009-01288
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

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

  At 6 months

Secondary Outcomes (1)

• Grade 3-5 Toxicity as Assessed by NCI CTC v3.0

  at 6 months from start of treatment

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.

Drug: ritonavir; Drug: lopinavir

Interventions

ritonavir DRUG

Given orally

Also known as: Norvir, RIT

Arm I

lopinavir DRUG

Given orally

Also known as: ABT-378/r

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Astrocytoma; Ependymoma; Oligodendroglioma; Glioblastoma; Gliosarcoma; Glioma

Interventions

Ritonavir; Lopinavir

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidinones; Pyrimidines

Results Point of Contact

• Title: David Peereboom, MD
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

peerebd@ccf.org

216-445-6068

Study Officials

• David Peereboom, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2010
• First Posted: March 29, 2010
• Study Start: January 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2011
• Last Updated: June 10, 2013
• Results First Posted: June 10, 2013

Record last verified: 2013-04

Locations

US (1)