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Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01017601
Recruitment Status : Terminated (Interim analysis declared futility.)
First Posted : November 20, 2009
Results First Posted : May 8, 2017
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lung Cancer
Interventions Biological: Seneca Valley virus-001
Other: placebo
Enrollment 59
Recruitment Details One-hundred twenty-one (121) participants were pre-registered and 59 participants were registered between January 2010 and January 2013. Study was terminated prematurely on 1/10/2013 due to an interim analysis that declared futility. No additional clinical and survival follow-up data are required as of 11/15/2014.
Pre-assignment Details Sixty-two participants were deemed screen failures: 26 progression, 21 did not meet eligibility criteria, 6 patient decision and 9 other reason. Out of the 59 randomized participants, there were 8 cancellations and one participant was found to be ineligible upon audit. All seventy-one participants mentioned above were excluded from all analyses.
Arm/Group Title Arm I (NTX-010) Arm II (Placebo)
Hide Arm/Group Description Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1. Patients receive a single dose of placebo IV over 1 hour on day 1.
Period Title: Overall Study
Started 26 24
Completed 14 11
Not Completed 12 13
Reason Not Completed
Disease Progression             12             12
Withdrawal by Subject             0             1
Arm/Group Title Arm I (NTX-010) Arm II (Placebo) Total
Hide Arm/Group Description Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1. Patients receive a single dose of placebo IV over 1 hour on day 1. Total of all reporting groups
Overall Number of Baseline Participants 26 24 50
Hide Baseline Analysis Population Description
All registered participants who have met eligibility criteria and started the treatment.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 26 participants 24 participants 50 participants
67
(44 to 81)
60
(50 to 82)
63
(44 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Female
12
  46.2%
14
  58.3%
26
  52.0%
Male
14
  53.8%
10
  41.7%
24
  48.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
24
  92.3%
24
 100.0%
48
  96.0%
Unknown or Not Reported
2
   7.7%
0
   0.0%
2
   4.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 24 participants 50 participants
26 24 50
Eastern Cooperative Oncology Group (ECOG) Performance Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
0=Asymptomatic and fully active 8 7 15
1=Symptomatic and fully ambulatory 18 17 35
Prior Response to Chemo  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Stable Disease (SD) 4 5 9
Partial Response (PR) 15 12 27
Complete Response (CR) 7 7 14
Cigarette History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Never Smoked 0 2 2
Current Smoker 7 4 11
Former Smoker 19 18 37
Time between Completion of Chemo to Randomization  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
1 month 10 9 19
2 months 10 10 20
3 months 6 4 10
Unknown 0 1 1
Prior Radiation Therapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Yes 8 9 17
No 18 15 33
Enrolling Group  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Previously untreated 3 4 7
Previously treated 23 20 43
1.Primary Outcome
Title Progression-free Survival
Hide Description The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first.
Time Frame Time from randomization to the disease progression or death (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All registered participants who have met eligibility criteria and started the treatment.
Arm/Group Title Arm I (NTX-010) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
Patients receive a single dose of placebo IV over 1 hour on day 1.
Overall Number of Participants Analyzed 26 24
Median (95% Confidence Interval)
Unit of Measure: months
1.7
(1.4 to 3.1)
1.7
(1.4 to 4.3)
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was defined as the time from study enrollment (randomization) to the time of death from any cause or last follow-up.
Time Frame Time from randomization to death or last follow-up (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All registered participants who have met eligibility criteria and started the treatment.
Arm/Group Title Arm I (NTX-010) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
Patients receive a single dose of placebo IV over 1 hour on day 1.
Overall Number of Participants Analyzed 26 24
Median (95% Confidence Interval)
Unit of Measure: months
6.6
(4.7 to 13.2)
13.1
(5.8 to 19.0)
3.Secondary Outcome
Title Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all non-nodal target lesions and each target lymph node must have reduction in short axis to <1.0 cm.; Partial Response (PR), at least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the Baseline Sum of Diameters; Overall Response (OR) = CR + PR.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All registered participants who have met eligibility criteria and started the treatment.
Arm/Group Title Arm I (NTX-010) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
Patients receive a single dose of placebo IV over 1 hour on day 1.
Overall Number of Participants Analyzed 26 24
Measure Type: Number
Unit of Measure: percentage of participants
Confirmed Response (CR/PR) 3.9 16.6
Stable Disease (SD) 15.4 8.3
Progression Disease (PD) 73.1 75.0
Non-CR/non-PD 3.9 0
Not evaluable 3.9 0
4.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was defined as the time from the date at which the patient’s earliest best objective status was first noted to be either a CR or PR to the earliest date progression was documented.
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with the patient's earliest best objective status was first noted to be a CR or PR.
Arm/Group Title Arm I (NTX-010) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
Patients receive a single dose of placebo IV over 1 hour on day 1.
Overall Number of Participants Analyzed 4 4
Median (95% Confidence Interval)
Unit of Measure: months
1.9
(1.4 to 19.4)
NA [1] 
(3.2 to NA)
[1]
Two participants had disease progression. Median time and the upper limit of 95% CI are unattainable.
5.Secondary Outcome
Title Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0
Hide Description Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. The maximum grade for each type of adverse events were recorded for each patient.
Time Frame Up to 23 months
Hide Outcome Measure Data
Hide Analysis Population Description
All registered participants who have met eligibility criteria and started the treatment.
Arm/Group Title Arm I (NTX-010) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
Patients receive a single dose of placebo IV over 1 hour on day 1.
Overall Number of Participants Analyzed 26 24
Measure Type: Count of Participants
Unit of Measure: Participants
9
  34.6%
5
  20.8%
6.Secondary Outcome
Title Change From Baseline to Day 20-29 in the LASA QOL
Hide Description Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 20-29 was calculated by subtracting the baseline scores from the scores at day 20-29. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.
Time Frame Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase)
Hide Outcome Measure Data
Hide Analysis Population Description
All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 20-29 QOL assessments.
Arm/Group Title Arm I (NTX-010) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
Patients receive a single dose of placebo IV over 1 hour on day 1.
Overall Number of Participants Analyzed 10 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
-9.0  (17.9) -5.7  (31.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (NTX-010), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method Wilcoxon Rank Sum
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Day 30-59 in the LASA QOL
Hide Description Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 30-59 was calculated by subtracting the baseline scores from the scores at day 30-59. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.
Time Frame Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase)
Hide Outcome Measure Data
Hide Analysis Population Description
All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 30-59 QOL assessments.
Arm/Group Title Arm I (NTX-010) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
Patients receive a single dose of placebo IV over 1 hour on day 1.
Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.7  (26.0) -1.0  (11.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (NTX-010), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Wilcoxon Rank Sum
Comments [Not Specified]
8.Secondary Outcome
Title Clinical Significance Change From Baseline to Day 20-29 in the LASA QOL
Hide Description Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 20-29 was calculated by subtracting the baseline scores from the scores at day 20-29. Clinical Significance change over time was determined by the percentage of patients that report an improvement of more than 10 points on the 0-100 point scale.
Time Frame Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase)
Hide Outcome Measure Data
Hide Analysis Population Description
All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 20-29 QOL assessments.
Arm/Group Title Arm I (NTX-010) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
Patients receive a single dose of placebo IV over 1 hour on day 1.
Overall Number of Participants Analyzed 10 7
Measure Type: Number
Unit of Measure: percentage of participants
10 28.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (NTX-010), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Clinical Significance Change From Baseline to Day 30-59 in the LASA QOL
Hide Description Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 30-59 was calculated by subtracting the baseline scores from the scores at day 30-59. Clinical Significance change over time was determined by the percentage of patients that report an improvement of more than 10 points on the 0-100 point scale.
Time Frame Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase)
Hide Outcome Measure Data
Hide Analysis Population Description
All registered participants who have met eligibility criteria and who have completed both baseline and the time point of day 30-59 QOL assessments.
Arm/Group Title Arm I (NTX-010) Arm II (Placebo)
Hide Arm/Group Description:
Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
Patients receive a single dose of placebo IV over 1 hour on day 1.
Overall Number of Participants Analyzed 9 10
Measure Type: Number
Unit of Measure: percentage of participants
22.2 20.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (NTX-010), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Up to 23 months
Adverse Event Reporting Description All registered participants who have met eligibility criteria and started the treatment.
 
Arm/Group Title Arm I (NTX-010) Arm II (Placebo)
Hide Arm/Group Description Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1. Patients receive a single dose of placebo IV over 1 hour on day 1.
All-Cause Mortality
Arm I (NTX-010) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (NTX-010) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/26 (3.85%)      0/24 (0.00%)    
Investigations     
Platelet count decreased  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Vascular disorders     
Thromboembolic event  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (NTX-010) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/26 (92.31%)      17/24 (70.83%)    
Gastrointestinal disorders     
Abdominal pain  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Constipation  1  3/26 (11.54%)  3 0/24 (0.00%)  0
Diarrhea  1  8/26 (30.77%)  11 1/24 (4.17%)  1
Nausea  1  2/26 (7.69%)  2 0/24 (0.00%)  0
Vomiting  1  1/26 (3.85%)  1 0/24 (0.00%)  0
General disorders     
Fatigue  1  8/26 (30.77%)  10 1/24 (4.17%)  1
Flu like symptoms  1  16/26 (61.54%)  20 6/24 (25.00%)  9
Infections and infestations     
Mucosal infection  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Skin infection  1  1/26 (3.85%)  1 1/24 (4.17%)  1
Investigations     
Creatinine increased  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Lymphocyte count decreased  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Neutrophil count decreased  1  2/26 (7.69%)  2 1/24 (4.17%)  1
Weight loss  1  5/26 (19.23%)  13 5/24 (20.83%)  15
White blood cell decreased  1  2/26 (7.69%)  2 1/24 (4.17%)  1
Metabolism and nutrition disorders     
Anorexia  1  2/26 (7.69%)  2 0/24 (0.00%)  0
Dehydration  1  2/26 (7.69%)  3 0/24 (0.00%)  0
Hyperglycemia  1  1/26 (3.85%)  2 0/24 (0.00%)  0
Hypokalemia  1  1/26 (3.85%)  1 1/24 (4.17%)  1
Hyponatremia  1  2/26 (7.69%)  2 1/24 (4.17%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Bone pain  1  0/26 (0.00%)  0 1/24 (4.17%)  1
Generalized muscle weakness  1  1/26 (3.85%)  4 1/24 (4.17%)  2
Musculoskeletal deformity  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Nervous system disorders     
Brachial plexopathy  1  0/26 (0.00%)  0 1/24 (4.17%)  1
Cognitive disturbance  1  1/26 (3.85%)  1 1/24 (4.17%)  1
Dizziness  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Headache  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Lethargy  1  1/26 (3.85%)  4 0/24 (0.00%)  0
Peripheral motor neuropathy  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Peripheral sensory neuropathy  1  2/26 (7.69%)  3 1/24 (4.17%)  5
Psychiatric disorders     
Confusion  1  2/26 (7.69%)  2 0/24 (0.00%)  0
Insomnia  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  6/26 (23.08%)  10 9/24 (37.50%)  18
Respiratory, thoracic and mediastinal disorders - Other, specify  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Tracheal stenosis  1  0/26 (0.00%)  0 1/24 (4.17%)  1
Vascular disorders     
Hypotension  1  1/26 (3.85%)  1 0/24 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAEV4.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Julian Molina, M.D, Ph.D.
Organization: Mayo Clinic
Phone: 507-284-1328
EMail: Molina.julian@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01017601     History of Changes
Other Study ID Numbers: NCCTG-N0923
NCCTG-N0923
CDR0000659547 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-01991 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: November 19, 2009
First Posted: November 20, 2009
Results First Submitted: November 29, 2016
Results First Posted: May 8, 2017
Last Update Posted: May 8, 2017