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

Colorectal Carcinoma Clinical Trial

Official title:

A Phase 1/2a Dose-escalation Study of JX 594 Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394939
• Other study ID #: JX594-CRC019
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2012
• Est. completion date: October 2015

Study information

• Verified date: December 2020
• Source: SillaJen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This was a Phase 1/2a, open-label, dose-escalation study in patients with advanced colorectal cancer (CRC)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

• Eastern Cooperative Oncology Group (ECOG) Performance Status 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 Centrual Nervous System (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.

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms
• CRC
• Vaccinia

Intervention

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

Drug:
• Irinotecan
180 mg/m2 IV every 2 weeks.

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Ottawa Hospital and Research Institute (OHRI)	Ottawa	Ontario
France	Hôpital Saint Antoine	Paris
France	Hôpital Hautepierre	Strasbourg
France	Institut Claudius Regaud	Toulouse
United States	Billings Clinic Cancer Center	Billings	Montana
United States	Gabrail Cancer Center	Canton	Ohio
United States	University of North Carolina	Chapel Hill	North Carolina
United States	The Ohio State University	Columbus	Ohio
United States	UCSD Moores Cancer Center	La Jolla	California
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Jennerex Biotherapeutics	Transgene

Countries where clinical trial is conducted

United States,  Canada,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study	Percentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), >=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.	Scans Every 8 weeks until radiographic progression was confirmed by the site.