Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
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.
Checked against the public recordLast updated May 8, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Alliance for Clinical Trials in Oncology
- Interventions being studied
- Biological: Seneca Valley virus-001; Other: placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Mayo Clinic ScottsdaleScottsdale, Arizona
- Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas
- East Bay Radiation Oncology CenterCastro Valley, California
- Valley Medical Oncology Consultants - Castro ValleyCastro Valley, California
- Valley Medical OncologyFremont, California
- Contra Costa Regional Medical CenterMartinez, California
- El Camino Hospital Cancer CenterMountain View, California
- Highland General HospitalOakland, California
- Alta Bates Summit Medical Center - Summit CampusOakland, California
- Bay Area Breast Surgeons, IncorporatedOakland, California
- CCOP - Bay Area Tumor InstituteOakland, California
- Larry G Strieff MD Medical CorporationOakland, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 8, 2017. Always confirm current availability with the study team.