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Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01394939
First Posted: July 15, 2011
Last Update Posted: January 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Transgene
Information provided by (Responsible Party):
SillaJen, Inc. ( Jennerex Biotherapeutics )
July 13, 2011
July 15, 2011
January 8, 2016
January 2012
June 2015   (Final data collection date for primary outcome measure)
  • Determine the maximally-tolerated dose (MTD) or maximum feasible dose (MFD) of JX-594 administered by 5 IV infusions alone and in combination with irinotecan [ Time Frame: DLTs evaluated until Week 5/Day36 ]
    Any of the following treatment related adverse events: Grade 4 toxicity (except isolated G4 lymphopenia lasting ≤ 7 days), Grade 3 or 4 hypotension, disseminated intravascular coagulation (DIC) or allergic reaction/hypersensitivity, Grade 3 non-hematologic toxicity persisting for > 7 days (except for transaminitis (increase in AST and/or ALT), which may last > 7 days if total bilirubin is normal or Grade 1 or flu-like symptoms that respond to standard treatments), or Grade 3 hematologic toxicity persisting for > 7 days.
  • Determine the safety of JX-594 administered by 5 IV infusions followed by up to 3 IV JX-594 boosts alone and in combination with irinotecan [ Time Frame: 28 days after last dose of JX-594 IV. ]
    Adverse events will be collected and assessed to assess safety and tolerability through 28 days after last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
  • Determine radiographic response rate of patients enrolled in the Phase 2a portion of the study [ Time Frame: Scans Every 8 weeks until Progression ]
    RECIST and Choi response criteria
  • Determine the maximally-tolerated dose (MTD) or maximum feasible dose (MFD) of JX-594 administered by 5 IV infusions alone and in combination with irinotecan [ Time Frame: DLTs evaluated until Week 5/Day36 ]
    Any of the following treatment related adverse events: Grade 4 toxicity (except isolated G4 lymphopenia lasting ≤ 7 days), Grade 3 or 4 hypotension, disseminated intravascular coagulation (DIC) or allergic reaction/hypersensitivity, Grade 3 non-hematologic toxicity persisting for > 7 days (except for transaminitis (increase in AST and/or ALT), which may last > 7 days if total bilirubin is normal or Grade 1 or flu-like symptoms that respond to standard treatments), or Grade 3 hematologic toxicity persisting for > 7 days.
  • Determine the safety of JX-594 administered by 5 IV infusions followed by up to 3 IT JX-594 boosts alone and in combination with irinotecan [ Time Frame: 28 days after last dose of JX-594 IV or IT. ]
    Adverse events will be collected and assessed to assess safety and tolerability through 28 days after last dose of JX-594 (or until all events considered probably or possibly related to JX-594 have resolved, stabilized, or returned to baseline status).
  • Determine radiographic response rate of patients enrolled in the Phase 2a portion of the study [ Time Frame: Scans Every 8 weeks until Progression ]
    RECIST and Choi response criteria
Complete list of historical versions of study NCT01394939 on ClinicalTrials.gov Archive Site
  • Progression Free Disease [ Time Frame: CT scans every 8 weeks until Progression ]
    CT scans performed every 8 weeks until documented tumor progression.
  • Survival [ Time Frame: Monthly until Death or Lost-to-Followup ]
    Compare overall survival time of patients treated with JX-594 alone or in combination with Irinotecan.
Same as current
Not Provided
Not Provided
 
Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
A Phase 1/2a Dose-escalation Study of JX 594 (Thymidine Kinase-Deactivated Vaccinia Virus Plus GM-CSF) Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Colorectal Carcinoma
  • CRC
  • Biological: JX-594
    Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
  • Drug: Irinotecan
    180 mg/m2 IV every 2 weeks.
  • Experimental: Single Agent
    JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
    Intervention: Biological: JX-594
  • Experimental: Combination
    JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9.
    Interventions:
    • Biological: JX-594
    • Drug: Irinotecan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
October 2015
June 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically-confirmed, advanced metastatic colorectal cancer failed treatment with fluoropyrimidine (fluoruracil or capecitabine) and oxaliplatin based therapies or had contradictions to treatment with these drugs as determined by the investigator
  • Failed treatment with irinotecan
  • Kras mutant tumor or Kras wild-type having failed cetuximab (Erbitux) or panitumumab (Vectibix) or had contradictions to treatment
  • Regorafenib-naïve (have not received regorafenib)
  • ECOG 0, 1 or 2
  • Measurable tumor (≥1 cm longest diameter)
  • Acceptable health status as determined by the investigator and blood work (Chemistry, Complete Blood Count, Coagulation)

Exclusion Criteria:

  • Intolerant to Irinotecan (if assigned to the combination arm: Cohort 3, Cohort 4 or Combination Expansion Arm)
  • Treatment with ketoconazole, enzyme-inducing anticonvulsants and St. John's Wort (if assigned to combination arm)
  • Significant immunodeficiency due to underlying illness and/or medication
  • History of severe exfoliative skin condition requiring systemic therapy within the past 2 years
  • Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions
  • Active cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
  • Viable CNS malignancy associated with clinical symptoms
  • Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks for mitomycin c or nitrosoureas)
  • Prior participation in any other research protocol involving an investigational medicinal product within 4 weeks prior to first treatment
  • Use of prohibited anti-viral medication, interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be discontinued within 14 days prior to any JX 594 dose
  • Inability to suspend treatment with anti-hypertensive medication for 48 hours prior to and 48 hours after all JX-594 treatments.
  • Pregnant or nursing an infant
  • Diagnosis of chronic inflammatory bowel disease and/or bowel obstruction.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   United States
 
 
NCT01394939
JX594-CRC019
No
Not Provided
Not Provided
SillaJen, Inc. ( Jennerex Biotherapeutics )
Jennerex Biotherapeutics
Transgene
Study Director: James Burke, MD Jennerex Biotherapeutics
Principal Investigator: Derek Jonker, MD Ottawa Hospital and Research Institute
SillaJen, Inc.
January 2016

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