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| Sponsor: | North Central Cancer Treatment Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT01017601 |
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 II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind 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 |
| Estimated Enrollment: | 99 |
| Study Start Date: | January 2010 |
| Estimated Primary Completion Date: | December 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
|
OBJECTIVES:
Primary
Secondary
Exploratory
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 vs 2 months vs 3 months). Patients are randomized to 1 of 2 treatment arms.
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 |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of extensive-stage small cell lung cancer (SCLC)
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
PATIENT CHARACTERISTICS:
Adequate lung function (i.e., not oxygen dependent)
No second primary malignancy within the past 5 years, except for the following:
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior radiotherapy, including WBRT, PCI, or Gamma Knife (2 weeks for palliative radiotherapy to skeletal metastases) meeting the following criteria:
Contacts and Locations
Show 185 Study Locations| Principal Investigator: | Julian Molina, MD, PhD | Mayo Clinic |
More Information
| Responsible Party: | Julian Molina, Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01017601 History of Changes |
| Other Study ID Numbers: | CDR0000659547, NCCTG-N0923 |
| Study First Received: | November 19, 2009 |
| Last Updated: | January 28, 2012 |
| Health Authority: | Unspecified |
|
extensive stage small cell lung cancer |
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |