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

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.