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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00625456
Other study ID # JX594-IV-011
Secondary ID
Status Completed
Phase Phase 1
First received February 19, 2008
Last updated November 30, 2015
Start date June 2008
Est. completion date June 2014

Study information

Verified date March 2012
Source SillaJen, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date June 2014
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Household contact exclusions:

- 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

- Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Ottawa Health Research Institute Ottawa Ontario
United States Billings Clinic Billings Montana
United States Cancer Centers of the Carolinas Greenville South Carolina
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Jennerex Biotherapeutics

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by intravenous (IV) infusion 4 weeks Yes
Primary 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 Yes
Secondary Determine the JX-594 pharmacokinetics and pharmacodynamics over time following IV infusion 4 weeks No
Secondary Determine the immune response to JX-594 following IV infusion 4 weeks No
Secondary Determine the delivery of JX-594 to, and concentration within, solid tumors following IV infusion 4 weeks No
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