Trial record 1 of 1 for:    NCT01017601
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Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT01017601
First received: November 19, 2009
Last updated: July 26, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Biological: Seneca Valley virus-001
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blinded Phase II Study of NTX-010, a Replication-Competent Picornavirus, After Standard Platinum-Containing Cytoreductive Induction Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Response rate (complete response and partial response) as assessed by RECIST criteria [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Time-to-disease progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Quality of life as assessed by the single-item Linear Analogue Self Assessment [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 99
Study Start Date: January 2010
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
Biological: Seneca Valley virus-001
Given IV
Placebo Comparator: Arm II
Patients receive a single dose of placebo IV over 1 hour on day 1.
Other: placebo
Given IV

Detailed Description:

OBJECTIVES:

Primary

  • To compare the progression-free survival (PFS) of patients with extensive-stage small cell lung cancer treated with Seneca Valley virus-001 (NTX-010) vs placebo.

Secondary

  • To compare the overall survival (OS) of patients treated with NTX-010 vs placebo.
  • To describe the adverse events profile and safety of NTX-010 in this patient population.
  • To determine the antitumor response rate, as assessed by RECIST criteria, and duration of tumor response in this patient population.
  • To assess the quality of life of this patient population.

Exploratory

  • To determine the relationship between the presence of neutralizing antibodies and PFS.
  • To assess whether or not a slow viral clearance is associated with better response as determined by PFS.
  • To determine any potential impact of the presence of one or several neuroendocrine markers in the tumor sample (synaptophysin, chromogranin, or CD56) on PFS and OS.
  • To determine any potential relationship between presence of cell surface determinants of NTX-010 tropism in the tumor tissue and clinical outcomes such as improved PFS and OS.
  • To determine any potential relationship between the loss of integrity of IFN signaling in the tumor tissue and clinical outcomes such as improved PFS and OS.
  • To assess whether or not the presence of circulating tumor cells permissive to NTX-010 is associated with better clinical outcomes as determined by PFS and OS.

OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 vs 1), tumor response to standard chemotherapy (partial response vs stable disease vs complete response), and time between completion of chemotherapy to randomization 1 month (≤1 month) vs 2 months (>1 month but ≤ 2 months) vs 3 months (> 2 months but ≤ 3 months). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
  • Arm II: Patients receive a single dose of placebo IV over 1 hour on day 1. In both arms, patients may also undergo prophylactic cranial irradiation (PCI) daily on days 22-35 if they have not previously undergone PCI or whole-brain radiotherapy.

Quality of life is assessed at baseline and then periodically during the study.

Blood samples are collected periodically for viral clearance and antiviral neutralizing antibody levels, circulating tumor cells, and other biomarker laboratory studies.

After completion of study therapy, patients are followed up periodically for up to 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01017601

  Show 196 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Principal Investigator: Julian Molina, MD, PhD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier: NCT01017601     History of Changes
Other Study ID Numbers: N0923, NCCTG-N0923, CDR0000659547, NCI-2011-01991
Study First Received: November 19, 2009
Last Updated: July 26, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alliance for Clinical Trials in Oncology:
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on April 22, 2014