NCT00625456

Brief Summary

This is a Phase I, open-label, dose-escalation trial in patients with advanced/metastatic solid tumors refractory to standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck. These tumor types were selected because evidence of biological activity was observed in these tumor types in a Phase I study of JX-594 (Pexa-Vec) administered by intratumoral injection in patients with metastatic disease to the liver. Patients will receive treatment at one of five dose levels in a sequential dose-escalating design.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 3, 2015

Status Verified

March 1, 2012

Enrollment Period

1.8 years

First QC Date

February 19, 2008

Last Update Submit

November 30, 2015

Conditions

MelanomaLung CancerRenal Cell CarcinomaSquamous Cell Carcinoma of the Head and Neck

Keywords

phase Iadvanced metastatic solid tumorsoncolytic virusvaccinia virusmelanomalung cancerrenal cell carcinomasquamous cell carcinoma of the head and neckPexa-Vec

Outcome Measures

Primary Outcomes (2)

  • Maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by intravenous (IV) infusion

    4 weeks

  • Safety/Toxicity: Incidence of treatment-related adverse events; treatment-related serious adverse events; treatment-related Grade 3/4 toxicities; and clinically-significant, treatment-related changes from baseline in routine laboratory parameters

    4 weeks

Secondary Outcomes (3)

  • Determine the JX-594 pharmacokinetics and pharmacodynamics over time following IV infusion

    4 weeks

  • Determine the immune response to JX-594 following IV infusion

    4 weeks

  • Determine the delivery of JX-594 to, and concentration within, solid tumors following IV infusion

    4 weeks

Study Arms (1)

Single Arm, dose escalation

EXPERIMENTAL

dose escalation starting dose 1e5 pfu/kg bw to 3e7 pfu/kg bw; Recombinant Vaccinia GM-CSF (JX-594)

Drug: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)

Interventions

Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)DRUG

Intravenous Dosage from 1 x 10\^5 pfu/kg to 3 x 10\^7 pfu/kg Intravenous infusion is administered once over a 60 minute period

Also known as: JX-594
Single Arm, dose escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically-confirmed, advanced/metastatic solid tumor refractory to standard therapy or the patient has refused or does not tolerate the standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck
  • At least one measurable tumor mass by CT/MRI (i.e. lesion that can accurately be measured in at least one dimension with longest diameter \> 1 cm)
  • At least one tumor mass amenable to biopsy and/or FNA
  • Expected survival for approximately 16 weeks or longer
  • Karnofsky Performance Score (KPS) ≥ 70
  • Age ≥18 years
  • WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3
  • ANC ≥ 1,500 cells/mm3
  • Hemoglobin ≥ 10 g/dL
  • Platelet count ≥ 100,000 plts/mm3
  • Total bilirubin ≤ 1.5 x ULN
  • AST, ALT ≤ 2.5 x ULN
  • Serum chemistries within normal limits (WNL) or Grade 1 - If patients are diabetic or have a screening random glucose \> 160 mg/dL, a fasting glucose must be done and patients must be WNL or Grade 1 in order to be eligible for the study.
  • Acceptable coagulation status: INR ≤ (ULN + 10%)
  • CD4 count ≥ 500/mm3

You may not qualify if:

  • Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)
  • Known myeloproliferative disorders requiring systemic therapy
  • History of exfoliative skin condition (e.g. eczema or ectopic dermatitis) requiring systemic therapy
  • Tumor(s) invading a major vascular structure (e.g. carotid artery)
  • Tumor(s) in location that would potentially result in significant clinical adverse effects if post-treatment tumor swelling were to occur (e.g. tumors impinging on the upper airway or affecting biliary tract drainage, etc.)
  • Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions
  • Severe or unstable cardiac disease
  • Current, known CNS malignancy (history of completely resected or irradiated brain metastases allowed)
  • Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks in case of mitomycin C or nitrosoureas)
  • Use of anti-viral, anti-platelet, or anti-coagulation medication \[Patients who discontinue such medications within 7 days prior to first treatment may be eligible for this study.\]
  • Pulse oximetry O2 saturation \<90% at rest
  • Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination
  • Women who are pregnant or nursing an infant
  • Children \< 5 years old
  • History of exfoliative skin condition (e.g. eczema) that at some stage has required systemic therapy
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Billings Clinic

Billings, Montana, 59101, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

Cancer Centers of the Carolinas

Greenville, South Carolina, 29605, United States

Location

Ottawa Health Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

MelanomaLung NeoplasmsCarcinoma, Renal CellSquamous Cell Carcinoma of Head and NeckVaccinia

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinoma, Squamous CellHead and Neck NeoplasmsPoxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • David Kirn, MD

    Jennerex Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 28, 2008

Study Start

June 1, 2008

Primary Completion

April 1, 2010

Study Completion

June 1, 2014

Last Updated

December 3, 2015

Record last verified: 2012-03

Locations

CA(1)US(3)