Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Seneca Valley virus-001; placebo
Intervention description: Given IV; Given IV
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: extensive stage small cell lung cancer

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.
    

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.