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.