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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Neotropix.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Neotropix
ClinicalTrials.gov Identifier:
NCT00314925
First received: April 13, 2006
Last updated: February 23, 2010
Last verified: February 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
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 Name: SVV-001

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314925

Locations
United States, Florida
Cancer Centers of Florida
Ocoee, Florida, United States, 34761
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, New York
New York Oncology Hematology P.C.
Albany, New York, United States, 12208
United States, Ohio
Dayton Oncology & Hematology, P.A .
Kettering, Ohio, United States, 45409
United States, South Carolina
Cancer Centers of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Texas
Mary Crowley Research Center
Dallas, Texas, United States, 75201
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Northwest Cancer Specialists - Vancouver Cancer Center
Vancouver, Washington, United States, 98684
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: Margaret Valnoski, President, Theradex, Inc.
ClinicalTrials.gov Identifier: NCT00314925     History of Changes
Other Study ID Numbers: N05-10564
Study First Received: April 13, 2006
Last Updated: February 23, 2010
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

ClinicalTrials.gov processed this record on October 23, 2014