Safety Study of Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380600
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|