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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Jennerex Biotherapeutics
Study ID
NCT01394939
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • JX-594 — BIOLOGICAL
    Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
  • Irinotecan — DRUG
    180 mg/m2 IV every 2 weeks.

Study Details

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.

Key Dates

Start date
Jan 31, 2012
Status verified
Dec 2020
Primary completion
Jun 30, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single Agent_ Cohort 1
    JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. JX-594: Recombinant Vaccinia Granulocyte-Macrophage Colony-Stimulating Factor (RAC VAC GM-CSF) Cohort 1: JX-594 3 x 10\^8 plaque forming unit (pfu), Days 1, 8,15, 22, and 29
  • Experimental: Single Agent_Cohort 2
    JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. JX-594: RAC VAC GM-CSF Cohort 2: JX-594 1 x 10\^9 pfu, Days 1, 8,15, 22, and 29
  • Experimental: Combination_Cohort 3
    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. JX-594: RAC VAC GM-CSF Irinotecan: 180 mg/m2 IV every 2 weeks. JX-594 3 x 10\^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.
  • Experimental: Combination_Cohort 4
    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. JX-594: RAC VAC GM-CSF JX-594 1 x 10\^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9.

Primary Outcome Measure

Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study [ Time Frame: Scans Every 8 weeks until radiographic progression was confirmed by the site. ]

Locations (6)

FacilityCityStateZIPSite coordinators
Mayo ClinicScottsdaleArizona85259-5499-
UCSD Moores Cancer CenterLa JollaCalifornia92093-
Billings Clinic Cancer CenterBillingsMontana59101-
University of North CarolinaChapel HillNorth Carolina27599-1651-
Gabrail Cancer CenterCantonOhio44718-
The Ohio State UniversityColumbusOhio43210-

Find similar trials in Scottsdale, AZ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Mayo Clinic· Scottsdale, AZUCSD Moores Cancer Center· La Jolla, CABillings Clinic Cancer Center· Billings, MTUniversity of North Carolina· Chapel Hill, NCGabrail Cancer Center· Canton, OHThe Ohio State University· Columbus, OH

Related Studies