Colorectal CarcinomaPhase 1NCT01469611
A Trial of JX-594 in Refractory Colorectal Carcinoma
A Phase 1 study testing JX-594 in people with Colorectal Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to: determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by biweekly intravenous (IV) infusion. determine the safety of JX-594(TK- GM-CSF+ Wyeth strain vaccinia) administered by biweekly IV infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- JX-594
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Jan 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-confirmed, advanced/metastatic colorectal carcinoma
- Failed both oxaliplatin and irinotecan based regimens for advanced/metastatic disease (tumor progression on or within 3 months of treatment completion)
- Erbitux therapy resistant: Ras mutant tumor status, and/or failed Erbitux therapy (tumor progression on or within 3 months of treatment completion or Erbitux treatment not indicated due to lack of epidermal growth factor (EGFR) expression)
- At least one measurable tumor mass by PET-CT/CT/MRI (lesion that can accurately be measured in at least one dimension with longest diameter > 1 cm)
- Expected survival for approximately 12 weeks or longer
- Karnofsky Performance Score (KPS) ≥ 70
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- Age ≥18 years
- WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3
- ANC ≥ 1,500 cells/mm3
- Hemoglobin ≥ 10 g/dL (transfusion allowed)
- Platelet count ≥ 100,000 plts/mm3
- Total bilirubin ≤ 1.5 ULN
- AST, ALT ≤2.5 ULN (if liver metastases(+): AST,ALT ≤5.0 x ULN)
- Serum chemistries within normal limits (WNL) or Grade 1 (excluding alkaline phosphatase) - If patients are diabetic or have a screening random glucose > 160 mg/dL, a fasting glucose must be done and patients must be WNL or Grade 1 in order to be eligible for the study.
Who cannot join
- Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)
- Known myeloproliferative disorders requiring systemic therapy
- History of exfoliative skin condition (e.g. eczema or ectopic dermatitis) requiring systemic therapy
- History of acquiring opportunistic infections.
- Tumor(s) invading a major vascular structure (e.g. carotid artery)
- Tumor(s) in location that would potentially result in significant clinical adverse effects if post-treatment tumor swelling were to occur (e.g. tumors impinging on the upper airway or affecting biliary tract drainage, etc.)
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- Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions
- Severe or unstable cardiac disease, including (for example) coronary artery disease requiring increased doses of anti-anginal mediation and/or coronary angioplasty (including stent placement) within the preceding 24 months
- Current, known CNS malignancy (history of completely resected or irradiated brain metastases by WBRT or stereotactic radiosurgery allowed)
- Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks in case of mitomycin C or nitrosoureas)
- Use of anti-viral, anti-platelet, or anti-coagulation medication [Patients who discontinue such medications within 7 days prior to first treatment may be eligible for this study.] Low dose aspirin (approximately 81 mg) allowed.
- Pulse oximetry O2 saturation <90% at rest
- Experienced a severe systemic reaction or side-effect as a result of a previous smallpox vaccination
- Household contact exclusions:
- Women who are pregnant or nursing an infant
- Children < 12 months old
- People with skin disease (e.g. eczema, atopic dermatitis, and related diseases Immunocompromised hosts (severe deficiencies in cell-mediated immunity, including AIDS, organ transplant recipients, hematologic malignancies)Patients with household contacts meeting any of the above criteria will be excluded unless alternate living arrangements can be made during the patient's dosing period and for at least 7 days following the last dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
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
The purpose of this study is to:
- determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by biweekly intravenous (IV) infusion.
- determine the safety of JX-594(TK- GM-CSF+ Wyeth strain vaccinia) administered by biweekly IV infusion.
Read the detailed description
This is a Phase 1b, open-label, dose-escalation trial in patients with advanced colorectal carcinoma (CRC) that have failed both oxaliplatin based and irinotecan based prior chemotherapy regimens for metastatic disease. Patients will receive treatment at one of three dose levels in a sequential dose-escalating design.
Three patients will be treated at each dose level unless a dose-limiting toxicity (DLT) is observed. Enrollment will proceed to the next dose level if 0 of 3 patients experiences a DLT; if one of the first 3 patients experiences a DLT, additional patients will be enrolled until a second patient experiences a DLT (which defines the toxic dose) or until six total patients have been treated at that dose level, whichever comes first. If a second DLT is not experienced within that cohort, dose escalation may continue.
Patients will be enrolled a minimum of 14 days after the first treatment of the immediately preceding patient for the first patient in any cohort or all remaining patients in a cohort with DLT.
If 2 DLTs are observed within a cohort, enrollment into the cohort will cease and the dose level immediately preceding that dose will be determined to be the MTD. Regulatory Authorities and the IRB will be notified as required if any patient dies within 28 days of product administration due to a serious and unexpected ADR that is determined by the Investigator to be possibly or probably related to JX-594.
Once the MTD and/or MFD is defined, an additional 3-6 patients may be enrolled at that dose level. Note: once the MTD and/or MFD is defined, treatment of additional patients at this dose level will no longer require inter-patient delays of 14 days.
- Conditions
- Colorectal Carcinoma
- Being tested
- JX-594
- Keywords
- advanced/metastatic colorectal carcinoma
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JX-594Biological
Infusion Procedure:JX-594 will be administered on the designated treatment days at a dose of either 1 x 106, 1 x 107 or 3 x 107 pfu per kg. Virus infusion should occur over 60 minutes (+/- 5 minutes). The final infusion volume of virus plus diluent will be approximately 250 mL.
| Study group | Role | What they receive |
|---|---|---|
| JX-594 | Experimental | Infusion Procedure:JX-594 will be administered on the designated treatment days at a dose of either 1 x 106, 1 x 107 or 3 x 107 pfu per kg. Virus infusion should occur over 60 minutes (+/- 5 minutes). The final infusion volume of virus plus diluent will be approximately 250 mL. Receives: Biological: JX-594 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximally-tolerated dose
Measured: 18 months
Determine the maximum-feasible dose
Measured: 18months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startJul 2010
- Primary completionOct 2012
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Suk Park, Samsung Medical Center
- Investigators
- Young suk park, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469611
- Sponsor's protocol ID
- SMC IRB 2009-06-055
- Status last verified
- Feb 2017
- First submitted
- 7 Nov 2011
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01469611
- Acronym / sponsor ID
- SMC IRB 2009-06-055
- Conditions
- Colorectal Carcinoma
- Keywords
- advanced/metastatic colorectal carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2010 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to:
- determine the maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by biweekly intravenous (IV) infusion.
- determine the safety of JX-594(TK- GM-CSF+ Wyeth strain vaccinia) administered by biweekly IV infusion.
Detailed description
This is a Phase 1b, open-label, dose-escalation trial in patients with advanced colorectal carcinoma (CRC) that have failed both oxaliplatin based and irinotecan based prior chemotherapy regimens for metastatic disease. Patients will receive treatment at one of three dose levels in a sequential dose-escalating design.
Three patients will be treated at each dose level unless a dose-limiting toxicity (DLT) is observed. Enrollment will proceed to the next dose level if 0 of 3 patients experiences a DLT; if one of the first 3 patients experiences a DLT, additional patients will be enrolled until a second patient experiences a DLT (which defines the toxic dose) or until six total patients have been treated at that dose level, whichever comes first. If a second DLT is not experienced within that cohort, dose escalation may continue.
Patients will be enrolled a minimum of 14 days after the first treatment of the immediately preceding patient for the first patient in any cohort or all remaining patients in a cohort with DLT.
If 2 DLTs are observed within a cohort, enrollment into the cohort will cease and the dose level immediately preceding that dose will be determined to be the MTD. Regulatory Authorities and the IRB will be notified as required if any patient dies within 28 days of product administration due to a serious and unexpected ADR that is determined by the Investigator to be possibly or probably related to JX-594.
Once the MTD and/or MFD is defined, an additional 3-6 patients may be enrolled at that dose level. Note: once the MTD and/or MFD is defined, treatment of additional patients at this dose level will no longer require inter-patient delays of 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JX-594 | Experimental | Biological: JX-594Infusion Procedure:JX-594 will be administered on the designated treatment days at a dose of either 1 x 106, 1 x 107 or 3 x 107 pfu per kg. Virus infusion should occur over 60 minutes (+/- 5 minutes). The final infusion volume of virus plus diluent will be approximately 250 mL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically-confirmed, advanced/metastatic colorectal carcinoma
- Failed both oxaliplatin and irinotecan based regimens for advanced/metastatic disease (tumor progression on or within 3 months of treatment completion)
- Erbitux therapy resistant: Ras mutant tumor status, and/or failed Erbitux therapy (tumor progression on or within 3 months of treatment completion or Erbitux treatment not indicated due to lack of epidermal growth factor (EGFR) expression)
- At least one measurable tumor mass by PET-CT/CT/MRI (lesion that can accurately be measured in at least one dimension with longest diameter > 1 cm)
- Expected survival for approximately 12 weeks or longer
Key exclusion criteria (17 listed)
- Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)
- Known myeloproliferative disorders requiring systemic therapy
- History of exfoliative skin condition (e.g. eczema or ectopic dermatitis) requiring systemic therapy
- History of acquiring opportunistic infections.
- Tumor(s) invading a major vascular structure (e.g. carotid artery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JX-594Infusion Procedure:JX-594 will be administered on the designated treatment days at a dose of either 1 x 106, 1 x 107 or 3 x 107 pfu per kg. Virus infusion should occur over 60 minutes (+/- 5 minutes). The final infusion volume of virus plus diluent will be approximately 250 mL. | Biological | JX-594 |
Primary outcome
Determine the maximally-tolerated dose
Time frame: 18 months
Determine the maximum-feasible dose
Time frame: 18months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young suk park, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JX-594 in people with Colorectal Carcinoma, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the maximally-tolerated dose (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.