Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
This study is currently recruiting participants.
Verified January 2012 by Jennerex Biotherapeutics
Sponsor:
Jennerex Biotherapeutics
Collaborator:
Transgene
Information provided by (Responsible Party):
Jennerex Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01394939
First received: July 13, 2011
Last updated: June 11, 2013
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Carcinoma CRC |
Biological: JX-594 Drug: Irinotecan |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
Further study details as provided by Jennerex Biotherapeutics:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]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. ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]RECIST and Choi response criteria
Secondary Outcome Measures:
- Progression Free Disease [ Time Frame: CT scans every 8 weeks until Progression ] [ Designated as safety issue: No ]CT scans performed every 8 weeks until documented tumor progression.
- Survival [ Time Frame: Monthly until Death or Lost-to-Followup ] [ Designated as safety issue: No ]Compare overall survival time of patients treated with JX-594 alone or in combination with Irinotecan.
| Estimated Enrollment: | 42 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Single Agent
JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts.
|
Biological: JX-594
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (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.
|
Biological: JX-594
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Drug: Irinotecan
180 mg/m2 IV every 2 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
- Severe or unstable cardiac disease
- 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
- Pregnant or nursing an infant
- Diagnosis of chronic inflammatory bowel disease and/or bowel obstruction.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394939
Contacts
| Contact: Patient Inquiry | patient_inquiry@jennerex.com |
Locations
| United States, Arizona | |
| Mayo Clinic | Recruiting |
| Scottsdale, Arizona, United States, 85259-5499 | |
| Contact: Clinical Trials Office 507-538-7623 | |
| Principal Investigator: Thorvardur Halfdanarson, MD | |
| United States, California | |
| UCSD Moores Cancer Center | Recruiting |
| La Jolla, California, United States, 92093 | |
| Contact: Bethany Parker 858-822-5369 bparker@ucsd.edu | |
| Contact: Clinical Trials Office 858-822-5354 CancerCTO@ucsd.edu | |
| Principal Investigator: Tony Reid, MD, PhD | |
| United States, Montana | |
| Billings Clinic Cancer Center | Recruiting |
| Billings, Montana, United States, 59101 | |
| Contact: Tricia Montgomery, RN, BSN, OCN 406-435-7483 TMontgomery@billingsclinic.org | |
| Contact: Jorge Nieva, M.D. | |
| Principal Investigator: Jorge Nieva, M.D. | |
| United States, North Carolina | |
| University of North Carolina | Active, not recruiting |
| Chapel Hill, North Carolina, United States, 27599-1651 | |
| United States, Ohio | |
| Gabrail Cancer Center | Recruiting |
| Canton, Ohio, United States | |
| Contact 330-492-3345 research@gabrailcancercenter.com | |
| Principal Investigator: Nashat Gabrail, MD | |
| The Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Mark Bloomston, MD 614-293-4583 Mark.Bloomston@osumc.edu | |
| Contact: Sanaa Tahiri, MD, CCRC Sanaa.Tahiri@osumc.edu | |
| Principal Investigator: P. Mark Bloomston, MD | |
| Canada, Ontario | |
| Juravinski Cancer Centre | Active, not recruiting |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Ottawa Hospital and Research Institute (OHRI) | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Julie Wells (613) 737-7700 ext 70211 jwells@toh.on.ca | |
| Contact: Catherine Fortin (613) 737-7700 ext 72368 cfortin@toh.on.ca | |
| Principal Investigator: Derek Jonker, MD | |
| France | |
| Hôpital Saint Antoine | Recruiting |
| Paris, France, 75012 | |
| Contact: Sarah Dumont, MD sarah.dumont@sat.aphp.fr | |
| Principal Investigator: Aimery de Gramont, MD | |
| Hôpital Hautepierre | Not yet recruiting |
| Strasbourg, France, 67098 | |
| Contact: Jean-Emmanuel Kurtz, MD j-emmanuel.kurtz@chru-strasbourg.fr | |
| Principal Investigator: Jean-Emmanuel Kurtz, MD | |
| Institut Claudius Regaud | Not yet recruiting |
| Toulouse, France, 31052 | |
| Contact: Jean-Pierre Delord, MD delord.jean-pierre@claudiusregaud.fr | |
| Principal Investigator: Jean-Pierre Delord, MD | |
Sponsors and Collaborators
Jennerex Biotherapeutics
Transgene
Investigators
| Study Director: | James Burke, MD | Jennerex Biotherapeutics |
| Principal Investigator: | Derek Jonker, MD | Ottawa Hospital and Research Institute |
More Information
No publications provided
| Responsible Party: | Jennerex Biotherapeutics |
| ClinicalTrials.gov Identifier: | NCT01394939 History of Changes |
| Other Study ID Numbers: | JX594-CRC019 |
| Study First Received: | July 13, 2011 |
| Last Updated: | June 11, 2013 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Jennerex Biotherapeutics:
|
Vaccinia Vaccinia Virus JX-594 Jennerex Colorectal Carcinoma Colorectal cancer Colon Cancer Rectal Cancer oncolytic virus |
viral therapy RAS mutant Erbitux failure Oxaliplatin failure FOLFOX failure FOLFIRI failure Irinotecan failure Pexa-Vec |
Additional relevant MeSH terms:
|
Carcinoma Colorectal Neoplasms Vaccinia Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Poxviridae Infections DNA Virus Infections Virus Diseases Irinotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 13, 2013