Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Jennerex Biotherapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Jennerex Biotherapeutics
ClinicalTrials.gov Identifier:
NCT00625456
First received: February 19, 2008
Last updated: January 13, 2014
Last verified: March 2012

February 19, 2008
January 13, 2014
June 2008
April 2010   (final data collection date for primary outcome measure)
  • Maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by intravenous (IV) infusion [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00625456 on ClinicalTrials.gov Archive Site
  • Determine the JX-594 pharmacokinetics and pharmacodynamics over time following IV infusion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Determine the immune response to JX-594 following IV infusion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Determine the delivery of JX-594 to, and concentration within, solid tumors following IV infusion [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors
A Phase I Dose Escalation Study of JX-594 (Thymidine Kinase-deleted Vaccinia Virus Plus GM-CSF) Administered by Intravenous Infusion in Patients With Refractory Solid Tumors

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Melanoma
  • Lung Cancer
  • Renal Cell Carcinoma
  • Squamous Cell Carcinoma of the Head and Neck
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
Other Name: JX-594
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
23
June 2014
April 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00625456
JX594-IV-011
Yes
Jennerex Biotherapeutics
Jennerex Biotherapeutics
Not Provided
Study Director: David Kirn, MD Jennerex Inc.
Jennerex Biotherapeutics
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP