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Safety Study of Seneca Valley Virus in Patients With Solid Tumors With Neuroendocrine Features
This study is currently recruiting participants.
Verified by Neotropix, September 2008
First Received: April 13, 2006   Last Updated: September 23, 2008   History of Changes
Sponsor: Neotropix
Information provided by: Neotropix
ClinicalTrials.gov Identifier: NCT00314925
  Purpose

The primary purpose of the study is to determine if Seneca Valley Virus may be administered safely to patients with certain types of advanced cancer.


Condition Intervention Phase
Carcinoid
Neuroendocrine
Drug: Seneca Valley Virus (biological agent)
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I Dose-Escalation Study of Seneca Valley Virus (SVV-001), a Replication-Competent Picornavirus, in Patients With Advanced Solid Tumors With Neuroendocrine Features

Resource links provided by NLM:


Further study details as provided by Neotropix:

Primary Outcome Measures:
  • Incidence of dose-limiting toxicity and determination of phase II dose [ Time Frame: Within 28 days of treatment administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of responses according to RECIST criteria [ Time Frame: Baseline; at Week 7, Day 7 following therapy and then confirmation scan at least 4 weeks later, if required; and every 2 months for up to 6 months, if required ] [ Designated as safety issue: No ]
  • Limited pharmacokinetics, biodistribution and elimination [ Time Frame: Until 2 consecutive negative viral assays ] [ Designated as safety issue: No ]
  • Limited evaluation of occurrence of neutralizing antibody [ Time Frame: Baseline and at Week 2, Day 1 following therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Seneca Valley Virus (biological agent)
Dose escalation (starting at 1 × 10^7 vp/kg), IV (in the vein) over 1 hour in a single administration

Detailed Description:

This is the first study in man of Seneca Valley Virus, a virus which seeks and kills certain tumors in non-human model systems. Subjects in this trial will be patients with advanced cancer displaying certain specified neuroendocrine features, pathologically; they will have exhausted standard methods of treatment for their tumor. The primary purpose of the trial is to determine if the virus may be administered safely. Additional purposes are to learn about the distribution of the virus in the body, the elimination of the virus from the body, the immune response to the virus and whether the virus might have some beneficial effects upon the tumors which the patients have. The first patients will be treated with low amounts of virus and subsequent patients may receive higher amounts. At the end of the trial, it is intended to select a dose for further study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have a histologically confirmed solid tumor (including carcinoid) with neuroendocrine features (i.e., expression of >= 1 of the following 3 markers: synaptophysin, chromogranin A, or CD56) that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
  • Patients must show evidence of disease progression in the three months prior to treatment with SVV-001.
  • Age >= 18 years. Because no dosing or adverse event data are currently available on the use of SVV-001 in patients <18 years of age, children are excluded from this study. Children may be eligible for future pediatric Phase I single-agent trials.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • Life expectancy >= 24 weeks.
  • Adequate bone marrow, hepatic, and renal function as defined below:

    • absolute lymphocyte count >= 1,000/ul
    • absolute neutrophil count >= 1,500/ul
    • platelets >= 100,000/ul
    • AST/ALT <= 2.5 x upper limit of normal (ULN) or <= 5 x ULN if liver metastases present
    • total bilirubin <= 1.5 x upper limit of normal
    • creatinine <= 1.5 x upper limit of normal OR

      • creatinine clearance (calculated) <= 60 mL/min/1.73 m2 for patients with creatinine > 1.5 x upper limit of normal.
  • Women must have been surgically sterilized or be post-menopausal.
  • Men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for up to 6 months.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Patients must have oxygen saturation of at least 95% on room air.
  • Patients must have measurable disease by RECIST (CT and/or MRI).

Exclusion Criteria:

  • Patients with small cell histology.
  • Patients who have been hospitalized for emergent conditions requiring inpatient evaluation, treatment or procedure during the 30 days prior to entry on study. In addition, emergent conditions requiring inpatient evaluation, treatment or procedure must have resolved or be medically stable and not severe for 30 days prior to entry on study.
  • Use of chemotherapy or radiotherapy within 4 weeks of initiation of SVV-001, or continued > Grade 1 adverse events, excluding alopecia, due to agents administered more than 4 weeks earlier.
  • Patients with clinically evident Human Immuno-deficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection.
  • Patients with > Grade 1 peripheral neuropathy (CTCAE version 3.0).
  • Concurrent use of any other investigational agents.
  • Presence of or history of central nervous system metastasis.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pre-menopausal women who have not been surgically sterilized. Although SVV-001 has no affect on the ovaries from a toxicological perspective, SVV-001 RNA is present in the ovaries at 12 weeks in animals that were administered high and medium doses. No pre-clinical reproductive tests have been conducted with SVV-001.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314925

Locations
United States, Florida
Cancer Centers of Florida Recruiting
Ocoee, Florida, United States, 34761
Contact: Lynn Hogue     407-297-6735     lynn.hogue@usoncology.com    
Principal Investigator: Carlos A. Alemany, MD            
United States, Indiana
Central Indiana Cancer Centers Recruiting
Indianapolis, Indiana, United States, 46219
Contact: Yvonne LaFary     317-964-5200     yvonne.lafary@usoncology.com    
Principal Investigator: David Loesch, MD            
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21231
Contact: Barbara Coleman     410-502-3474     bcolema1@jhmi.edu    
Principal Investigator: Charles Rudin, MD, PhD            
United States, New York
New York Oncology Hematology P.C. Recruiting
Albany, New York, United States, 12208
Contact: Michele Butler     518-489-2607     michele.butler@usoncology.com    
Principal Investigator: Lawrence Garbo, MD            
United States, Ohio
Dayton Oncology & Hematology, P.A . Recruiting
Kettering, Ohio, United States, 45409
Contact: Michelle Owens     937-528-0317     michelle.owens@usoncology.com    
Principal Investigator: Robert Raju, MD            
United States, South Carolina
Cancer Centers of the Carolinas Recruiting
Greenville, South Carolina, United States, 29605
Contact: Lisa Johnson     864-679-3966     Lisa.Johnson@usoncology.com    
Contact: Sebrina Madden     864-679-3966     Sebrina.Madden@USONCOLOGY.COM    
Principal Investigator: Joe Stephenson, MD            
United States, Texas
Tyler Cancer Center Recruiting
Tyler, Texas, United States, 75702
Contact: Linda Dunklin     903-579-9867     linda.dunklin@usoncology.com    
Principal Investigator: Don Richards, MD            
Mary Crowley Research Center Recruiting
Dallas, Texas, United States, 75201
Contact: Ned Adams, RN     214-370-1815     nadams@marycrowley.org    
Principal Investigator: Neil Senzer, MD            
United States, Virginia
Virginia Oncology Associates Recruiting
Norfolk, Virginia, United States, 23502
Contact: Gabrielle Geho     757-213-5637     gabrielle.geho@usoncology.com    
Principal Investigator: Paul Conkling, MD            
United States, Washington
Northwest Cancer Specialists - Vancouver Cancer Center Recruiting
Vancouver, Washington, United States, 98684
Contact: Judy Welch     360-449-6522     judith.welch@usoncology.com    
Principal Investigator: David Smith, MD            
Sponsors and Collaborators
Neotropix
Investigators
Study Chair: Rudin Charles, MD, PhD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Theradex, Inc. ( Margaret Valnoski, President )
Study ID Numbers: N05-10564
Study First Received: April 13, 2006
Last Updated: September 23, 2008
ClinicalTrials.gov Identifier: NCT00314925     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Neotropix:
advanced carcinoma
carcinoid
neuroendocrine features
oncolytic virus
phase I study
dose escalation study
rhabdomyosarcoma
alveolar rhabdomyosarcoma
medulloblastoma
rhabdoid
glioblastoma
ewing's sarcoma
pediatric oncologies
neuroblastoma
wilms' tumor
retinoblastoma
Large cell lung cancer

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Carcinoid Tumor
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma
Neuroendocrine Tumors

ClinicalTrials.gov processed this record on November 20, 2009