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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentClosed18 and overNCI, OtherN0923
NCCTG-N0923, CDR0000659547, NCI-2011-01991, NCT01017601

Trial Description

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.

Further Study Information

OBJECTIVES:

Primary

  • To compare the progression-free survival (PFS) of patients with extensive-stage small cell lung cancer treated with Seneca Valley virus-001 (NTX-010) vs placebo.

Secondary

  • To compare the overall survival (OS) of patients treated with NTX-010 vs placebo.
  • To describe the adverse events profile and safety of NTX-010 in this patient population.
  • To determine the antitumor response rate, as assessed by RECIST criteria, and duration of tumor response in this patient population.
  • To assess the quality of life of this patient population.

Exploratory

  • To determine the relationship between the presence of neutralizing antibodies and PFS.
  • To assess whether or not a slow viral clearance is associated with better response as determined by PFS.
  • To determine any potential impact of the presence of one or several neuroendocrine markers in the tumor sample (synaptophysin, chromogranin, or CD56) on PFS and OS.
  • To determine any potential relationship between presence of cell surface determinants of NTX-010 tropism in the tumor tissue and clinical outcomes such as improved PFS and OS.
  • To determine any potential relationship between the loss of integrity of IFN signaling in the tumor tissue and clinical outcomes such as improved PFS and OS.
  • To assess whether or not the presence of circulating tumor cells permissive to NTX-010 is associated with better clinical outcomes as determined by PFS and OS.

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 vs 1), tumor response to standard chemotherapy (partial response vs stable disease vs complete response), and time between completion of chemotherapy to randomization 1 month (≤1 month) vs 2 months (>1 month but ≤ 2 months) vs 3 months (> 2 months but ≤ 3 months). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
  • Arm II: Patients receive a single dose of placebo IV over 1 hour on day 1. In both arms, patients may also undergo prophylactic cranial irradiation (PCI) daily on days 22-35 if they have not previously undergone PCI or whole-brain radiotherapy.

Quality of life is assessed at baseline and then periodically during the study.

Blood samples are collected periodically for viral clearance and antiviral neutralizing antibody levels, circulating tumor cells, and other biomarker laboratory studies.

After completion of study therapy, patients are followed up periodically for up to 5 years.

Eligibility Criteria

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

North Central Cancer Treatment Group

National Cancer Institute

Julian MolinaPrincipal Investigator

Trial Sites

U.S.A.
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 765-983-3000
Michigan
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
  Kalamazoo
 Borgess Medical Center
 Raymond Sterling Lord Ph: 269-373-7458
 Bronson Methodist Hospital
 Raymond Sterling Lord Ph: 269-373-7458
 West Michigan Cancer Center
 Raymond Sterling Lord Ph: 269-373-7458
North Carolina
  Rutherfordton
 Rutherford Hospital
 James Dewitt Bearden Ph: 800-486-5941
North Dakota
  Bismarck
 Bismarck Cancer Center
 Edward J. Wos Ph: 701-323-5760
  Email: tfischer@mohs.org
South Carolina
  Anderson
 AnMed Cancer Center
 James Dewitt Bearden Ph: 800-486-5941
 James Dewitt Bearden Ph: 800-486-5941
  Greenville
 Bon Secours St. Francis Health System
 James Dewitt Bearden Ph: 800-486-5941
  Spartanburg
 CCOP - Upstate Carolina
 James Dewitt Bearden Ph: 800-486-5941
 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
 James Dewitt Bearden Ph: 800-486-5941

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01017601
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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