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.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 8, 2017 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
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
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.