| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01288 | Other Identifier | NCI/CTRP |
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Study did not meet its primary objective
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ritonavir | Drug | Given orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Number of patients that remained disease free at 6 months from start of treatment. | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Grade 3-5 Toxicity as Assessed by NCI CTC v3.0 | Number of participants with adverse events grades 3-5. For a detailed list of adverse events see the adverse event module. | at 6 months from start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Peereboom, MD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
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Patients were recruited from medical clinic May 2008 to May 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I | Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity. ritonavir : Given orally lopinavir : Given orally |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| lopinavir | Drug | Given orally |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I | Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity. ritonavir : Given orally lopinavir : Given orally |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | Number of patients that remained disease free at 6 months from start of treatment. | Posted | Number | participants | At 6 months |
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| Secondary | Grade 3-5 Toxicity as Assessed by NCI CTC v3.0 | Number of participants with adverse events grades 3-5. For a detailed list of adverse events see the adverse event module. | Posted | Number | participants | at 6 months from start of treatment |
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Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I | Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity. ritonavir : Given orally lopinavir : Given orally | 5 | 19 | 17 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Neuropathy: motor | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Incontinence, urinary | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Edema: limb | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Death not associated with CTCAE term - Disease progression NOS | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Elevated AST, SGOT(serum glutamic oxaloacetic transaminase) | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Ataxia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Cholesterol, serum-high (hypercholesteremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Cognitive disturbance | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Confusion | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae) | Endocrine disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dysphagia (difficulty swallowing) | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Edema: limb | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Flu-like syndrome | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Bad Breath | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| hot Flashes/Flushes | Endocrine disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Incontinence, urinary | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Memory impairment | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Mood alteration - Anxiety | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Mood alteration - Depression | Psychiatric disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Neuropathy: cranial - CN XII Motor-tongue | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Neuropathy: motor | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Ocular/Visual - Other (Specify, Foggy Vision) | Eye disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain - Bone | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Pain - Head/headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Thrombocytopenia | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Potassium, serum-low (hypokalemia) | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Rigors/chills | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Salivary gland changes/ increased saliva | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Seizure | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Speech impairment (e.g., dysphasia or aphasia) | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Sweating (diaphoresis) | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Triglyceride, serum-high (hypertriglyceridemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Weight Loss | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Pain - Neck | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Peereboom, MD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | 216-445-6068 | peerebd@ccf.org |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D001254 | Astrocytoma |
| D004806 | Ependymoma |
| D009837 | Oligodendroglioma |
| D005909 | Glioblastoma |
| D018316 | Gliosarcoma |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D019438 | Ritonavir |
| D061466 | Lopinavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
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| Title | Measurements |
|---|---|
|
| 60-69 years |
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| 70-79 years |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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