Trial Outcomes & Findings for Viral Therapy in Treating Patients With Metastatic Melanoma (NCT NCT00651157)
NCT ID: NCT00651157
Last Updated: 2014-04-22
Results Overview
A tumor response is defined to be a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD.
COMPLETED
PHASE2
23 participants
Every 4 weeks after 4 courses of treatment, assessed up to 5 years
2014-04-22
Participant Flow
Twenty three participants were enrolled onto this study between August 2008 and January 2010.
One participant died prior to receiving any treatment and is not included in this study summary. One participant was found to be ineligible and was not used in the analysis of any endpoint, but was used for reporting toxicity. Therefore, 21 participants were used for the primary analysis and 22 participants are used to report toxicity.
Participant milestones
| Measure |
Treatment (Viral Therapy)
Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Viral Therapy)
Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Viral Therapy in Treating Patients With Metastatic Melanoma
Baseline characteristics by cohort
| Measure |
Treatment (Viral Therapy)
n=21 Participants
Patients receive wild-type reovirus (Reolysin®) IV administered at a dose of 3 x 10\^10 TCID50/day in 250 mL 0.9% sodium chloride infused intravenously over 60 minutes daily on days 1-5 of each 28-day cycle. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
65 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Every 4 weeks after 4 courses of treatment, assessed up to 5 yearsA tumor response is defined to be a Complete Response (CR) or Partial Response (PR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Treatment (Viral Therapy)
n=21 Participants
Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Tumor Response
Complete Response (CR)
|
0 participants
|
|
Tumor Response
Partial Response (PR)
|
0 participants
|
SECONDARY outcome
Timeframe: Time from registration to death due to any cause, assessed up to 5 yearsSurvival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
Outcome measures
| Measure |
Treatment (Viral Therapy)
n=21 Participants
Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
5.42 months
Interval 0.49 to 15.8
|
SECONDARY outcome
Timeframe: Time from registration to documentation of disease progression, assessed up to 5 yearsTime to disease progression is defined as the time from registration to documentation of disease progression. If a patient dies without documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death.
Outcome measures
| Measure |
Treatment (Viral Therapy)
n=21 Participants
Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Time to Disease Progression
|
45 days
Interval 13.0 to 96.0
|
Adverse Events
Treatment (Viral Therapy)
Serious adverse events
| Measure |
Treatment (Viral Therapy)
n=22 participants at risk
Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
9.1%
2/22 • Number of events 2
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
1/22 • Number of events 1
|
|
Cardiac disorders
Left ventricular failure
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Disease progression
|
4.5%
1/22 • Number of events 1
|
|
General disorders
Fatigue
|
9.1%
2/22 • Number of events 2
|
|
General disorders
Fever
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Alkaline phosphatase increased
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Laboratory test abnormal
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Leukocyte count decreased
|
9.1%
2/22 • Number of events 2
|
|
Investigations
Lymphocyte count decreased
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
9.1%
2/22 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
4.5%
1/22 • Number of events 1
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
4.5%
1/22 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
18.2%
4/22 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
9.1%
2/22 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum calcium increased
|
4.5%
1/22 • Number of events 1
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
9.1%
2/22 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
4.5%
1/22 • Number of events 1
|
|
Nervous system disorders
Ischemia cerebrovascular
|
4.5%
1/22 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
9.1%
2/22 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
4.5%
1/22 • Number of events 1
|
|
Renal and urinary disorders
Ureteric obstruction
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
1/22 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.5%
1/22 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
4.5%
1/22 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Viral Therapy)
n=22 participants at risk
Patients receive wild-type reovirus (Reolysin®) IV over 60 minutes on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
72.7%
16/22 • Number of events 27
|
|
Gastrointestinal disorders
Diarrhea
|
18.2%
4/22 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
54.5%
12/22 • Number of events 16
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
6/22 • Number of events 6
|
|
General disorders
Chills
|
50.0%
11/22 • Number of events 16
|
|
General disorders
Fatigue
|
86.4%
19/22 • Number of events 29
|
|
General disorders
Fever
|
50.0%
11/22 • Number of events 18
|
|
Investigations
Leukocyte count decreased
|
27.3%
6/22 • Number of events 9
|
|
Investigations
Lymphocyte count decreased
|
4.5%
1/22 • Number of events 1
|
|
Investigations
Neutrophil count decreased
|
9.1%
2/22 • Number of events 2
|
|
Investigations
Platelet count decreased
|
40.9%
9/22 • Number of events 11
|
|
Metabolism and nutrition disorders
Anorexia
|
54.5%
12/22 • Number of events 17
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
4.5%
1/22 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
54.5%
12/22 • Number of events 14
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
27.3%
6/22 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.7%
5/22 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
13.6%
3/22 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60