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

NCT00314925 | Unknown Phase 1

• 1 other identifier: N05-10564
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Carcinoid; Neuroendocrine

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of dose-limiting toxicity and determination of phase II dose

  Within 28 days of treatment administration

Secondary Outcomes (3)

• Number of responses according to RECIST criteria

  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

  Until 2 consecutive negative viral assays

• Limited evaluation of occurrence of neutralizing antibody

  Baseline and at Week 2, Day 1 following therapy

Study Arms (1)

1

EXPERIMENTAL

Drug: Seneca Valley Virus (biological agent)

Interventions

Seneca Valley Virus (biological agent) DRUG

Dose escalation (starting at 1 × 10\^7 vp/kg), IV (in the vein) over 1 hour in a single administration

Also known as: SVV-001

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neotropix: lead

Study Sites (10)

Cancer Centers of Florida

Ocoee, Florida, 34761, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46219, United States

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

New York Oncology Hematology P.C.

Albany, New York, 12208, United States

Location

Dayton Oncology & Hematology, P.A .

Kettering, Ohio, 45409, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Mary Crowley Research Center

Dallas, Texas, 75201, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Northwest Cancer Specialists - Vancouver Cancer Center

Vancouver, Washington, 98684, United States

Location

Related Publications (1)

• Venkataraman S, Reddy SP, Loo J, Idamakanti N, Hallenbeck PL, Reddy VS. Crystallization and preliminary X-ray diffraction studies of Seneca Valley virus-001, a new member of the Picornaviridae family. Acta Crystallogr Sect F Struct Biol Cryst Commun. 2008 Apr 1;64(Pt 4):293-6. doi: 10.1107/S1744309108006921. Epub 2008 Mar 21.

  PMID: 18391430 DERIVED

Related Links

• website of sponsor

MeSH Terms

Conditions

Carcinoid Tumor; Rhabdomyosarcoma; Rhabdomyosarcoma, Alveolar; Medulloblastoma; Glioblastoma; Sarcoma, Ewing; Neuroblastoma; Wilms Tumor; Retinoblastoma

Interventions

Biological Factors

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors, Primitive; Astrocytoma; Osteosarcoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Retinal Neoplasms; Eye Neoplasms; Eye Diseases, Hereditary; Eye Diseases; Retinal Diseases

Study Officials

• Rudin Charles, MD, PhD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 13, 2006
• First Posted: April 17, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 25, 2010

Record last verified: 2010-02

Locations

US (10)