Trial Outcomes & Findings for Ritonavir and Lopinavir in Treating Patients With Progressive or Recurrent High-Grade Glioma (NCT NCT01095094)
NCT ID: NCT01095094
Last Updated: 2013-06-10
Results Overview
Number of patients that remained disease free at 6 months from start of treatment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
At 6 months
Results posted on
2013-06-10
Participant Flow
Patients were recruited from medical clinic May 2008 to May 2009.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Ritonavir and Lopinavir in Treating Patients With Progressive or Recurrent High-Grade Glioma
Baseline characteristics by cohort
| Measure |
Arm I
n=19 Participants
Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
ritonavir : Given orally
lopinavir : Given orally
|
|---|---|
|
Age, Customized
30-39 years
|
4 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
5 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
7 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
1 Participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsNumber of patients that remained disease free at 6 months from start of treatment.
Outcome measures
| Measure |
Arm I
n=16 Participants
Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
ritonavir : Given orally
lopinavir : Given orally
|
|---|---|
|
Progression-free Survival
|
4 participants
|
SECONDARY outcome
Timeframe: at 6 months from start of treatmentNumber of participants with adverse events grades 3-5. For a detailed list of adverse events see the adverse event module.
Outcome measures
| Measure |
Arm I
n=19 Participants
Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
ritonavir : Given orally
lopinavir : Given orally
|
|---|---|
|
Grade 3-5 Toxicity as Assessed by NCI CTC v3.0
|
7 participants
|
Adverse Events
Arm I
Serious events: 5 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=19 participants at risk
Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
ritonavir : Given orally
lopinavir : Given orally
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Neuropathy: motor
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Renal and urinary disorders
Incontinence, urinary
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
General disorders
Edema: limb
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
General disorders
Death not associated with CTCAE term - Disease progression NOS
|
21.1%
4/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
Other adverse events
| Measure |
Arm I
n=19 participants at risk
Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
ritonavir : Given orally
lopinavir : Given orally
|
|---|---|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.5%
2/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Investigations
Elevated AST, SGOT(serum glutamic oxaloacetic transaminase)
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Ataxia
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Metabolism and nutrition disorders
Cholesterol, serum-high (hypercholesteremia)
|
26.3%
5/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Cognitive disturbance
|
10.5%
2/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Confusion
|
10.5%
2/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Endocrine disorders
Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae)
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Gastrointestinal disorders
Diarrhea
|
57.9%
11/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
21.1%
4/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
General disorders
Edema: limb
|
10.5%
2/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
36.8%
7/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
General disorders
Flu-like syndrome
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Gastrointestinal disorders
Bad Breath
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
10.5%
2/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
10.5%
2/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Endocrine disorders
hot Flashes/Flushes
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Renal and urinary disorders
Incontinence, urinary
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Memory impairment
|
21.1%
4/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Mood alteration - Anxiety
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Psychiatric disorders
Mood alteration - Depression
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
21.1%
4/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy) - Extremity-lower
|
15.8%
3/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Gastrointestinal disorders
Nausea
|
15.8%
3/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Neuropathy: cranial - CN XII Motor-tongue
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Neuropathy: motor
|
21.1%
4/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Eye disorders
Ocular/Visual - Other (Specify, Foggy Vision)
|
10.5%
2/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Pain - Head/headache
|
15.8%
3/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Investigations
Thrombocytopenia
|
15.8%
3/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Investigations
Potassium, serum-low (hypokalemia)
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
10.5%
2/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
General disorders
Rigors/chills
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Gastrointestinal disorders
Salivary gland changes/ increased saliva
|
10.5%
2/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Seizure
|
15.8%
3/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
21.1%
4/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
General disorders
Sweating (diaphoresis)
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Metabolism and nutrition disorders
Triglyceride, serum-high (hypertriglyceridemia)
|
36.8%
7/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Investigations
Weight Loss
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Musculoskeletal and connective tissue disorders
Pain - Neck
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Neuropathy: sensory
|
5.3%
1/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
|
Nervous system disorders
Dizziness
|
10.5%
2/19 • Adverse Event data was collected on all patients while on study over a 3 year 5 month period.
|
Additional Information
David Peereboom, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: 216-445-6068
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place