Safety Study of Seneca Valley Virus in Patients With Solid Tumors With Neuroendocrine Features

February 23, 2010 updated by: Neotropix

Phase I Dose-Escalation Study of Seneca Valley Virus (SVV-001), a Replication-Competent Picornavirus, in Patients With Advanced Solid Tumors With Neuroendocrine Features

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Ocoee, Florida, United States, 34761
        • Cancer Centers of Florida
    • Indiana
      • Indianapolis, Indiana, United States, 46219
        • Central Indiana Cancer Centers
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology P.C.
    • Ohio
      • Kettering, Ohio, United States, 45409
        • Dayton Oncology & Hematology, P.A .
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Cancer Centers of the Carolinas
    • Texas
      • Dallas, Texas, United States, 75201
        • Mary Crowley Research Center
      • Tyler, Texas, United States, 75702
        • Tyler Cancer Center
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
    • Washington
      • Vancouver, Washington, United States, 98684
        • Northwest Cancer Specialists - Vancouver Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
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
Other Names:
  • SVV-001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of dose-limiting toxicity and determination of phase II dose
Time Frame: Within 28 days of treatment administration
Within 28 days of treatment administration

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Limited pharmacokinetics, biodistribution and elimination
Time Frame: Until 2 consecutive negative viral assays
Until 2 consecutive negative viral assays
Limited evaluation of occurrence of neutralizing antibody
Time Frame: Baseline and at Week 2, Day 1 following therapy
Baseline and at Week 2, Day 1 following therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neotropix

Investigators

  • Study Chair: Rudin Charles, MD, PhD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (ANTICIPATED)

December 1, 2008

Study Completion (ANTICIPATED)

December 1, 2008

Study Registration Dates

First Submitted

April 13, 2006

First Submitted That Met QC Criteria

April 13, 2006

First Posted (ESTIMATE)

April 17, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 25, 2010

Last Update Submitted That Met QC Criteria

February 23, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N05-10564

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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