Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study did not meet its primary objective
Summary
Brief summary (as posted)
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
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Astrocytoma | Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Anaplastic Ependymoma | Anaplastic Ependymoma | ONTOLOGY_EXACT | 0.90 |
| Anaplastic Oligodendroglioma | Anaplastic Oligodendroglioma | CURATED_BROADER | 0.80 |
| Brain Stem Glioma | Brain Stem Glioma | ONTOLOGY_EXACT | 0.90 |
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Giant Cell Glioblastoma | Giant Cell Glioblastoma | ONTOLOGY_EXACT | 0.90 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Gliosarcoma | Gliosarcoma | ONTOLOGY_EXACT | 0.90 |
| Mixed Glioma | Mixed Glioma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lopinavir | Drug | — | UNRESOLVED |
| ritonavir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: ritonavir
- Drug: lopinavir
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- At 6 months
- description
- Number of patients that remained disease free at 6 months from start of treatment.
Secondary outcomes (1)
- measure
- Grade 3-5 Toxicity as Assessed by NCI CTC v3.0
- timeFrame
- at 6 months from start of treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available