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

This study has been terminated.
(Interim analysis declared futility.)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01017601
First received: November 19, 2009
Last updated: March 28, 2017
Last verified: March 2017
Results First Received: November 29, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Arm I (NTX-010) Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
Arm II (Placebo) Patients receive a single dose of placebo IV over 1 hour on day 1.

Participant Flow:   Overall Study
    Arm I (NTX-010)   Arm II (Placebo)
STARTED   26   24 
COMPLETED   14   11 
NOT COMPLETED   12   13 
Disease Progression                12                12 
Withdrawal by Subject                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All registered participants who have met eligibility criteria and started the treatment.

Reporting Groups
  Description
Arm I (NTX-010) Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
Arm II (Placebo) Patients receive a single dose of placebo IV over 1 hour on day 1.
Total Total of all reporting groups

Baseline Measures
   Arm I (NTX-010)   Arm II (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   24   50 
Age 
[Units: Years]
Median (Full Range)
 67 
 (44 to 81) 
 60 
 (50 to 82) 
 63 
 (44 to 82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      12  46.2%      14  58.3%      26  52.0% 
Male      14  53.8%      10  41.7%      24  48.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   26   24   50 
Eastern Cooperative Oncology Group (ECOG) Performance Status 
[Units: Participants]
Count of Participants
     
0=Asymptomatic and fully active   8   7   15 
1=Symptomatic and fully ambulatory   18   17   35 
Prior Response to Chemo 
[Units: Participants]
Count of Participants
     
Stable Disease (SD)   4   5   9 
Partial Response (PR)   15   12   27 
Complete Response (CR)   7   7   14 
Cigarette History 
[Units: Participants]
Count of Participants
     
Never Smoked   0   2   2 
Current Smoker   7   4   11 
Former Smoker   19   18   37 
Time between Completion of Chemo to Randomization 
[Units: Participants]
Count of Participants
     
1 month   10   9   19 
2 months   10   10   20 
3 months   6   4   10 
Unknown   0   1   1 
Prior Radiation Therapy 
[Units: Participants]
Count of Participants
     
Yes   8   9   17 
No   18   15   33 
Enrolling Group 
[Units: Participants]
Count of Participants
     
Previously untreated   3   4   7 
Previously treated   23   20   43 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: Time from randomization to the disease progression or death (up to 5 years) ]

2.  Secondary:   Overall Survival   [ Time Frame: Time from randomization to death or last follow-up (up to 5 years) ]

3.  Secondary:   Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)   [ Time Frame: Up to 5 years ]

4.  Secondary:   Duration of Response   [ Time Frame: Up to 5 years ]

5.  Secondary:   Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0   [ Time Frame: Up to 23 months ]

6.  Secondary:   Change From Baseline to Day 20-29 in the LASA QOL   [ Time Frame: Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase) ]

7.  Secondary:   Change From Baseline to Day 30-59 in the LASA QOL   [ Time Frame: Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase) ]

8.  Secondary:   Clinical Significance Change From Baseline to Day 20-29 in the LASA QOL   [ Time Frame: Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase) ]

9.  Secondary:   Clinical Significance Change From Baseline to Day 30-59 in the LASA QOL   [ Time Frame: Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Julian Molina, M.D, Ph.D.
Organization: Mayo Clinic
phone: 507-284-1328
e-mail: Molina.julian@mayo.edu



Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01017601     History of Changes
Other Study ID Numbers: NCCTG-N0923
CDR0000659547 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-01991 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
Study First Received: November 19, 2009
Results First Received: November 29, 2016
Last Updated: March 28, 2017