MelanomaPhase 1NCT00625456
Safety Study of Recombinant Vaccinia Virus to Treat Refractory Solid Tumors
A Phase 1 study testing Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) in people with Melanoma and Lung Cancer, run by Jennerex Biotherapeutics at 4 sites in 2 countries.
Trial summary
This is a Phase I, open-label, dose-escalation trial in patients with advanced/metastatic solid tumors refractory to standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Lung Cancer, Renal Cell Carcinoma
- What is being tested?
- Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2008to Jun 2014
- 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 solid tumor refractory to standard therapy or the patient has refused or does not tolerate the standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck
- At least one measurable tumor mass by CT/MRI (i.e. lesion that can accurately be measured in at least one dimension with longest diameter > 1 cm)
- At least one tumor mass amenable to biopsy and/or FNA
- Expected survival for approximately 16 weeks or longer
- Karnofsky Performance Score (KPS) ≥ 70
- Age ≥18 years
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- WBC ≥ 3,500 cells/mm3 and ≤ 50,000 cells/mm3
- ANC ≥ 1,500 cells/mm3
- Hemoglobin ≥ 10 g/dL
- Platelet count ≥ 100,000 plts/mm3
- Total bilirubin ≤ 1.5 x ULN
- AST, ALT ≤ 2.5 x ULN
- Serum chemistries within normal limits (WNL) or Grade 1 - 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.
- Acceptable coagulation status: INR ≤ (ULN + 10%)
- CD4 count ≥ 500/mm3
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
- 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.)
- Clinically significant and/or rapidly accumulating ascites, peri-cardial and/or pleural effusions
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- Severe or unstable cardiac disease
- Current, known CNS malignancy (history of completely resected or irradiated brain metastases 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.]
- 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 < 5 years old
- History of exfoliative skin condition (e.g. eczema) that at some stage has required systemic therapy
- Significant immunodeficiency due to underlying illness (e.g. HIV/AIDS) and/or medication (e.g. systemic corticosteroids)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Billings Clinic
Billings, Montana, 59101
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
University of Pennsylvania
Philadelphia, Pennsylvania
About this study
Official title: A Phase I Dose Escalation Study of JX-594 (Thymidine Kinase-deleted Vaccinia Virus Plus GM-CSF) Administered by Intravenous Infusion in Patients With Refractory Solid Tumors
This is a Phase I, open-label, dose-escalation trial in patients with advanced/metastatic solid tumors refractory to standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck. These tumor types were selected because evidence of biological activity was observed in these tumor types in a Phase I study of JX-594 (Pexa-Vec) administered by intratumoral injection in patients with metastatic disease to the liver. Patients will receive treatment at one of five dose levels in a sequential dose-escalating design.
- Being tested
- Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
- Keywords
- phase I, advanced metastatic solid tumors, oncolytic virus, vaccinia virus, melanoma, lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, Pexa-Vec
- Medical subject headings
- Melanoma, Lung Neoplasms, Carcinoma, Renal Cell, Squamous Cell Carcinoma of Head and Neck, Vaccinia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)Drug
Also called JX-594
Intravenous Dosage from 1 x 10^5 pfu/kg to 3 x 10^7 pfu/kg Intravenous infusion is administered once over a 60 minute period
| Study group | Role | What they receive |
|---|---|---|
| Single Arm, dose escalation | Experimental | dose escalation starting dose 1e5 pfu/kg bw to 3e7 pfu/kg bw; Recombinant Vaccinia GM-CSF (JX-594) Receives: Drug: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by intravenous (IV) infusion
Measured: 4 weeks
Safety/Toxicity: Incidence of treatment-related adverse events; treatment-related serious adverse events; treatment-related Grade 3/4 toxicities; and clinically-significant, treatment-related changes from baseline in routine laboratory parameters
Measured: 4 weeks
Secondary outcomes (3)
Determine the JX-594 pharmacokinetics and pharmacodynamics over time following IV infusion
Measured: 4 weeks
Determine the immune response to JX-594 following IV infusion
Measured: 4 weeks
Determine the delivery of JX-594 to, and concentration within, solid tumors following IV infusion
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startJun 2008
- Primary completionApr 2010
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennerex Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Kirn, MD, Study director, Jennerex Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00625456
- Sponsor's protocol ID
- JX594-IV-011
- Status last verified
- Mar 2012
- First submitted
- 19 Feb 2008
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of JX-594 (Thymidine Kinase-deleted Vaccinia Virus Plus GM-CSF) Administered by Intravenous Infusion in Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00625456
- Acronym / sponsor ID
- JX594-IV-011
- Keywords
- phase I, advanced metastatic solid tumors, oncolytic virus, vaccinia virus, melanoma, lung cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Jennerex BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Feb 2008 (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.
This is a Phase I, open-label, dose-escalation trial in patients with advanced/metastatic solid tumors refractory to standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck. These tumor types were selected because evidence of biological activity was observed in these tumor types in a Phase I study of JX-594 (Pexa-Vec) administered by intratumoral injection in patients with metastatic disease to the liver. Patients will receive treatment at one of five dose levels in a sequential dose-escalating design.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm, dose escalation | Experimental | Drug: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)dose escalation starting dose 1e5 pfu/kg bw to 3e7 pfu/kg bw; Recombinant Vaccinia GM-CSF (JX-594) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically-confirmed, advanced/metastatic solid tumor refractory to standard therapy or the patient has refused or does not tolerate the standard therapy; tumors may include malignant melanoma, non-small cell lung cancer, renal cell carcinoma, and squamous cell carcinoma of the head and neck
- At least one measurable tumor mass by CT/MRI (i.e. lesion that can accurately be measured in at least one dimension with longest diameter > 1 cm)
- At least one tumor mass amenable to biopsy and/or FNA
- Expected survival for approximately 16 weeks or longer
- Karnofsky Performance Score (KPS) ≥ 70
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
- 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.)
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 |
|---|---|---|
| Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)Also: JX-594Intravenous Dosage from 1 x 10^5 pfu/kg to 3 x 10^7 pfu/kg Intravenous infusion is administered once over a 60 minute period | Drug | Single Arm, dose escalation |
Primary outcome
Maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by intravenous (IV) infusion
Time frame: 4 weeks
Safety/Toxicity: Incidence of treatment-related adverse events; treatment-related serious adverse events; treatment-related Grade 3/4 toxicities; and clinically-significant, treatment-related changes from baseline in routine laboratory parameters
Time frame: 4 weeks
3 secondary outcomes
Determine the JX-594 pharmacokinetics and pharmacodynamics over time following IV infusion
Time frame: 4 weeks
Determine the immune response to JX-594 following IV infusion
Time frame: 4 weeks
Determine the delivery of JX-594 to, and concentration within, solid tumors following IV infusion
Time frame: 4 weeks
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 3 Dec 2015.
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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.
David Kirn, MD study director
Jennerex Inc.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) in people with Melanoma and Lung Cancer, run by Jennerex Biotherapeutics at 4 sites in 2 countries.
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 15 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada. 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?
Maximally-tolerated dose (MTD) and/or maximum-feasible dose (MFD) of JX-594 administered by intravenous (IV) infusion (time frame: 4 weeks). 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 3 Dec 2015.