Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Registration Number
- NCT01017601
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 59
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Progression-free Survival Time from randomization to the disease progression or death (up to 5 years) The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first.
- Secondary Outcome Measures
Name Time Method Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0 Up to 23 months Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. The maximum grade for each type of adverse events were recorded for each patient.
Clinical Significance Change From Baseline to Day 30-59 in the LASA QOL Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase) Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 30-59 was calculated by subtracting the baseline scores from the scores at day 30-59. Clinical Significance change over time was determined by the percentage of patients that report an improvement of more than 10 points on the 0-100 point scale.
Overall Survival Time from randomization to death or last follow-up (up to 5 years) Overall survival was defined as the time from study enrollment (randomization) to the time of death from any cause or last follow-up.
Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Up to 5 years A confirmed tumor response was defined as a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all non-nodal target lesions and each target lymph node must have reduction in short axis to \<1.0 cm.; Partial Response (PR), at least a 30% decrease in the sum of the longest diameters of the non-nodal target lesions and the short axes of the target lymph nodes taking as reference the Baseline Sum of Diameters; Overall Response (OR) = CR + PR.
Duration of Response Up to 5 years Duration of response was defined as the time from the date at which the patient's earliest best objective status was first noted to be either a CR or PR to the earliest date progression was documented.
Change From Baseline to Day 20-29 in the LASA QOL Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase) Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 20-29 was calculated by subtracting the baseline scores from the scores at day 20-29. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.
Change From Baseline to Day 30-59 in the LASA QOL Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase) Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 30-59 was calculated by subtracting the baseline scores from the scores at day 30-59. Negative change indicates the QOL decrease and positive change indicates the QOL improvement.
Clinical Significance Change From Baseline to Day 20-29 in the LASA QOL Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase) Quality of Life (QOL) was measured using the single-item Linear Analogue Self Assessment (LASA) on a 0-10 scale, with 0=as bad as it can be and 10=as good as it can be. The QOL scores was converted to a 100-point scale, with 0=Low QOL and 100=Best QOL. Change from baseline to day 20-29 was calculated by subtracting the baseline scores from the scores at day 20-29. Clinical Significance change over time was determined by the percentage of patients that report an improvement of more than 10 points on the 0-100 point scale.
Trial Locations
- Locations (196)
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
East Bay Radiation Oncology Center
🇺🇸Castro Valley, California, United States
Valley Medical Oncology Consultants - Castro Valley
🇺🇸Castro Valley, California, United States
Valley Medical Oncology
🇺🇸Fremont, California, United States
Contra Costa Regional Medical Center
🇺🇸Martinez, California, United States
El Camino Hospital Cancer Center
🇺🇸Mountain View, California, United States
Highland General Hospital
🇺🇸Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
Bay Area Breast Surgeons, Incorporated
🇺🇸Oakland, California, United States
Scroll for more (186 remaining)Mayo Clinic Scottsdale🇺🇸Scottsdale, Arizona, United States