NCT01017601|TerminatedPhase 2ResultsDMC

Study Stopped

Interim analysis declared futility.

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

A Randomized Double-Blinded Phase II Study of NTX-010, a Replication-Competent Picornavirus, After Standard Platinum-Containing Cytoreductive Induction Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

Compare

3 other identifiers

NCCTG-N0923CDR0000659547NCI-2011-01991

Study Type

interventional

Target

Locations

1 country

Sites

196

Timeline

RegisteredNov 2009

StartedJan 2010

CompletionNov 2014

Brief Summary

RATIONALE: A virus called Seneca Valley virus-001 (NTX-010) may be able to kill tumor cells without damaging normal cells. It is not yet known whether NTX-010 is more effective than a placebo in treating small cell lung cancer. PURPOSE: This randomized phase II trial is studying NTX-010 to see how well it works compared with a placebo when given after chemotherapy in treating patients with extensive-stage small cell lung cancer.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2 lung-cancer

Timeline

Completed

Started Jan 2010

Typical duration for phase_2 lung-cancer

Geographic Reach

1 country

196 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.9 years study duration

First Submitted

Initial submission to the registry

November 19, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed

1 month until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed

1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2014

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

May 8, 2017

Completed

Last Updated

May 8, 2017

Status Verified

March 1, 2017

Enrollment Period

3 years

First QC Date

November 19, 2009

Results QC Date

November 29, 2016

Last Update Submit

March 28, 2017

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

Progression-free Survival
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 from randomization to the disease progression or death (up to 5 years)

Secondary Outcomes (8)

Overall Survival
Time from randomization to death or last follow-up (up to 5 years)
Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Up to 5 years
Duration of Response
Up to 5 years
Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0
Up to 23 months
Change From Baseline to Day 20-29 in the LASA QOL
Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase)
+3 more secondary outcomes

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.

Biological: Seneca Valley virus-001

Arm II

PLACEBO COMPARATOR

Patients receive a single dose of placebo IV over 1 hour on day 1.

Other: placebo

Interventions

Seneca Valley virus-001BIOLOGICAL

Given IV

Arm I

placeboOTHER

Given IV

Arm II

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of extensive-stage small cell lung cancer (SCLC) * No mixed histology * Presence of ≥ 1 neuroendocrine marker (synaptophysin, chromogranin, or CD56) in tumor tissue * Achieved partial response (PR), complete response (CR), or stable disease (SD) ≤ 12 weeks of completing 4-6 courses of platinum-based chemotherapy regimen for extensive-stage SCLC * Patients with PR or SD must have measurable disease, defined as ≥ 1 lesion whose longest diameter can be accurately measured as ≥ 2.0 cm but \< 10 cm by chest x-ray OR as ≥ 1.0 cm but \< 10 cm by CT scan, CT component of a PET/CT scan, or MRI * If CT scan is used, it must be used for both pre- and post-treatment tumor assessments * Measurable disease is not required for patients with CR * Brain metastases allowed provided they have been stable for ≥ 4 weeks after completion of prior radiotherapy PATIENT CHARACTERISTICS: * ECOG performance status 0 or 1 * Life expectancy of ≥ 8 weeks * ANC ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Hemoglobin ≥ 9 g/dL * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal * AST ≤ 3 times ULN (≤ 5 times ULN if liver has tumor involvement) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use adequate contraception * Able to comply with study procedures to minimize virus exposure to others * Willing to provide required biologic specimens * Willing to return to NCCTG/CTSU enrolling institution for follow-up * Adequate lung function (i.e., not oxygen dependent) * The patient is eligible if not on a 24-hour oxygen schedule * No second primary malignancy within the past 5 years, except for the following: * Carcinoma in situ of the cervix * Non-melanomatous skin cancer * History of low-grade (Gleason score ≤ 6) localized prostate cancer (even if diagnosed \< 5 years prior to study entry) * Stage I breast cancer that was treated ≥ 5 years before study entry * Transitional cell carcinoma of the bladder (in situ) * No active hepatitis B or hepatitis C * No clinically significant infection * No significant traumatic injury within the past 4 weeks * No concurrent uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to skeletal metastases) * Other prior radiation therapy (including WBRT, PCI, or Gamma Knife) is permitted as long as the following are true: * Recovered from prior radiotherapy (alopecia allowed) * No prior consolidation radiation therapy to the chest * No prior radiotherapy to \> 25% of bone marrow * For patients without brain metastases, WBRT or standard of care PCI completed ≥ 2 weeks before administration of NTX- 010/placebo * More than 365 days since prior immunotherapy or biologic therapy * More than 4 weeks since prior major surgery\* (i.e., laparotomy) or open biopsy * More than 2 weeks since prior minor surgery\* * No prior exposure to the Seneca Valley virus (NTX-010), as determined by negative serum antibodies * No concurrent combination antiretroviral therapy for HIV-positive patients NOTE: \*Insertion of a vascular access device is not considered major or minor surgery.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (196)

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259-5499, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Highland General Hospital

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus