Safety Study of Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
|ClinicalTrials.gov Identifier: NCT01380600|
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : January 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Colorectal||Drug: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Dose Escalation Study of JX-594 (Thymidine Kinase-Inactivated Vaccinia Virus Plus GM-CSF) Administered by Biweekly (Every Two Weeks) Intravenous Infusion in Patients With Metastatic, Refractory Colorectal Carcinoma|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||December 2015|
single arm; Dose escalation
Dose escalation 1e6 pfu/kg bw, 1e7 pfu/kg bw, 3e7 pfu/kg bw of Recombinant Vaccinia GM-CSF JX-594
Drug: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Intravenous Dose Range: 1x10^6 pfu/kg, 1x10^7 pfu/kg, 3x10^7 pfu/kg Up to 4 intravenous infusions administered over 60 minutes every 2 weeks.
Other Name: JX-594
- Determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by biweekly intravenous (IV) infusion [ Time Frame: DLT evaluations through 14 days following last JX-594 treatment ]Any of the following treatment related adverse events: Grade 4 toxicity, Grade 3 hematologic toxicity for > 5 days, Grade 3 non-hematologic toxicities persisting for > 7 days except for flu-like symptoms that respond to standard therapies.
- Determine the safety of JX-594 administered by biweekly IV infusion [ Time Frame: Safety evaluations through 28 days after last dose of JX-594 ]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 the pharmacokinetics, pharmacodynamics and immune response activity of JX-594 [ Time Frame: Blood samples collected at assigned time points from baseline through Week 8 ]Change over time in viral genomes, infectious units, GM-CSF concentration, peripheral white blood cell counts, plasma cytokine measurements, and neutralizing antibodies to JX-594 in blood and/or serum.
- Determine the anti-tumoral response of JX-594 [ Time Frame: Disease control and response assessment at Week 8 ]Tumor response (Stable, partial, complete, progression) by standard RECIST on CT/MRI. Decrease in tumor blood marker.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380600
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|