Melanoma (Skin)Phase 1NCT00471133
Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation
A Phase 1 study testing Xenogeneic Tyrosinase DNA Vaccine and TriGrid Delivery System for Intramuscular Electroporation in people with Melanoma (Skin) and Intraocular Melanoma, run by Ichor Medical Systems Incorporated at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of a DNA vaccine encoding a melanosomal antigen in melanoma patients at risk for disease progression or recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin), Intraocular Melanoma
- What is being tested?
- Xenogeneic Tyrosinase DNA Vaccine and TriGrid Delivery System for Intramuscular Electroporation
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to May 2010
- 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
- Patients must have documented, histologically confirmed malignant melanoma, American Joint Commission on Cancer (AJCC) Stage IIB- IV. Patients with stage IIb-III disease are only eligible after standard surgical care with wide local excision and appropriate lymph node sampling. Patients with stage IIb, IIc, or III melanoma who are free of disease after surgical resection are also eligible, only if they have refused high dose Interferon-alfa (INTRON A) or have had a recurrence while on Interferon-alfa.
- Patients with choroidal melanoma may participate if they fulfill one of the following criteria: Basal diameter >16mm; Height >8mm or involvement of the ciliary body with tumor.
- Patients must be at least 18 years of age and must be capable of understanding the consent form and giving informed consent.
- Karnofsky Score > 80
- Life Expectancy > 6 months
- HLA-A1, A2, A24, or B35+ as assessed by low resolution phenotyping
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- White blood cell count ≥ 2,000/mm3
- Platelet count ≥ 100,000/mm3
- Neutrophil count ≥ 1,000/mm3
- Hemoglobin ≥ 9.0 g/dL
- Serum AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Serum Bilirubin ≤ 2.0 mg/dL
- Serum Creatinine ≤ 2.0 mg/dL
- Serum Alkaline Phosphatase < 2.5 times ULN
- Serum Creatine phosphokinase (CPK) < 2.5 times ULN
Who cannot join
- Documented metastases in brain
- Clinical history of HIV, HepB, HepC, and/or HTLV I.
- Active autoimmune disease other than vitiligo
- Patients previously immunized using the tyrosinase DNA sequence, protein, or peptides.
- Systemic immunosuppressive therapy (corticosteroids, or other immunosuppressive drugs) within the previous 28 days
- Surgery and/or radiotherapy within the previous 28 days
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- Chemotherapy and/or biotherapy within the previous 28 days
- Participation in an investigational study within previous 28 days
- Patients with cardiac demand pacemakers.
- Women who are pregnant or < 3 months post partum or nursing.
- Women of child-bearing potential and sexually active men must be using appropriate contraception during the course of this study.
- Any other concurrent medical condition that in the opinion of the Principal Investigator or co-Principal Investigator's would preclude study compliance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase Ia/Ib Study of the Safety and Immunogenicity of a Xenogeneic Tyrosinase DNA Vaccine Melanoma
The purpose of this study is to evaluate the safety and immunogenicity of a DNA vaccine encoding a melanosomal antigen in melanoma patients at risk for disease progression or recurrence. In this study, the vaccine will be administered intramuscularly using a device that applies brief electrical fields to the tissue at the site of injection (a technique known as electroporation). It is expected that this device will improve the delivery of the vaccine. This study is being performed to determine if this procedure can be administered safely and if it is capable of inducing immune responses to the vaccine.
Read the detailed description
This study is designed to evaluate administration of a xenogeneic DNA vaccine encoding the melanosomal antigen tyrosinase by in vivo electroporation in patients with malignant melanoma. The objectives of the study are to characterize the safety and immunogenicity of a DNA vaccine encoding the murine tyrosinase gene delivered administered intramuscularly using the electroporation based TriGrid Delivery System (Ichor Medical Systems). We will assess the nature, frequency, and severity of any toxicity associated with vaccination at escalating pINGmuTyr doses and then expand enrollment at then expand enrollment at the Maximum Tolerated Dose to assess immunologic responses to the tyrosinase antigen.
The hypotheses being tested are that the procedure is feasible and safe and that it induces immune responses specific for tyrosinase in patients with stage IIB-IV malignant melanoma.
- Conditions
- Melanoma (Skin), Intraocular Melanoma
- Being tested
- Xenogeneic Tyrosinase DNA Vaccine, TriGrid Delivery System for Intramuscular Electroporation
- Keywords
- melanoma, DNA vaccine, tyrosinase, electroporation
- Medical subject headings
- Melanoma, Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenogeneic Tyrosinase DNA VaccineBiological
TriGrid Delivery System for Intramuscular ElectroporationDevice
| Study group | Role | What they receive |
|---|---|---|
| Xenogeneic Tyrosinase | Experimental | Not described Receives: Biological: Xenogeneic Tyrosinase DNA Vaccine; Device: TriGrid Delivery System for Intramuscular Electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and feasibility of electroporation mediated intramuscular delivery of a mouse tyrosinase plasmid DNA vaccine in patients with stage IIB, IIC, III, or IV melanoma.
Measured: one year
Secondary outcomes (2)
Assess patients with measurable tumor for evidence of anti-tumor response following immunization.
Measured: 6 months
Assess the magnitude and frequency of tyrosinase specific immunologic responses in the immunized patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ichor Medical Systems Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Investigators
- Jedd D. Wolchok, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00471133
- Sponsor's protocol ID
- 07-003
- Status last verified
- Jun 2011
- First submitted
- 8 May 2007
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Yuan J, Ku GY, Adamow M, Mu Z, Tandon S, Hannaman D, Chapman P, Schwartz G, Carvajal R, Panageas KS, Houghton AN, Wolchok JD. Immunologic responses to xenogeneic tyrosinase DNA vaccine administered by electroporation in patients with malignant melanoma. J Immunother Cancer. 2013 Nov 18;1:20. doi: 10.1186/2051-1426-1-20. eCollection 2013.
PubMed 24829756
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib Study of the Safety and Immunogenicity of a Xenogeneic Tyrosinase DNA Vaccine Melanoma
- ClinicalTrials.gov ID
- NCT00471133
- Acronym / sponsor ID
- 07-003
- Conditions
- Melanoma (Skin), Intraocular Melanoma
- Keywords
- melanoma, DNA vaccine, tyrosinase, electroporation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ichor Medical Systems IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- Apr 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 9 May 2007 (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 evaluate the safety and immunogenicity of a DNA vaccine encoding a melanosomal antigen in melanoma patients at risk for disease progression or recurrence. In this study, the vaccine will be administered intramuscularly using a device that applies brief electrical fields to the tissue at the site of injection (a technique known as electroporation). It is expected that this device will improve the delivery of the vaccine. This study is being performed to determine if this procedure can be administered safely and if it is capable of inducing immune responses to the vaccine.
Detailed description
This study is designed to evaluate administration of a xenogeneic DNA vaccine encoding the melanosomal antigen tyrosinase by in vivo electroporation in patients with malignant melanoma. The objectives of the study are to characterize the safety and immunogenicity of a DNA vaccine encoding the murine tyrosinase gene delivered administered intramuscularly using the electroporation based TriGrid Delivery System (Ichor Medical Systems). We will assess the nature, frequency, and severity of any toxicity associated with vaccination at escalating pINGmuTyr doses and then expand enrollment at then expand enrollment at the Maximum Tolerated Dose to assess immunologic responses to the tyrosinase antigen.
The hypotheses being tested are that the procedure is feasible and safe and that it induces immune responses specific for tyrosinase in patients with stage IIB-IV malignant melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xenogeneic Tyrosinase | Experimental | Biological: Xenogeneic Tyrosinase DNA Vaccine, Device: TriGrid Delivery System for Intramuscular Electroporation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have documented, histologically confirmed malignant melanoma, American Joint Commission on Cancer (AJCC) Stage IIB- IV. Patients with stage IIb-III disease are only eligible after standard surgical care with wide local excision and appropriate lymph node sampling. Patients with stage IIb, IIc, or III melanoma who are free of disease after surgical resection are also eligible, only if they have refused high dose Interferon-alfa (INTRON A) or have had a recurrence while on Interferon-alfa.
- Patients with choroidal melanoma may participate if they fulfill one of the following criteria: Basal diameter >16mm; Height >8mm or involvement of the ciliary body with tumor.
- Patients must be at least 18 years of age and must be capable of understanding the consent form and giving informed consent.
- Karnofsky Score > 80
- Life Expectancy > 6 months
Key exclusion criteria (12 listed)
- Documented metastases in brain
- Clinical history of HIV, HepB, HepC, and/or HTLV I.
- Active autoimmune disease other than vitiligo
- Patients previously immunized using the tyrosinase DNA sequence, protein, or peptides.
- Systemic immunosuppressive therapy (corticosteroids, or other immunosuppressive drugs) within the previous 28 days
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 |
|---|---|---|
| Xenogeneic Tyrosinase DNA Vaccine | Biological | Xenogeneic Tyrosinase |
| TriGrid Delivery System for Intramuscular Electroporation | Device | Xenogeneic Tyrosinase |
Primary outcome
Evaluate the safety and feasibility of electroporation mediated intramuscular delivery of a mouse tyrosinase plasmid DNA vaccine in patients with stage IIB, IIC, III, or IV melanoma.
Time frame: one year
2 secondary outcomes
Assess patients with measurable tumor for evidence of anti-tumor response following immunization.
Time frame: 6 months
Assess the magnitude and frequency of tyrosinase specific immunologic responses in the immunized patients
Time frame: 6 months
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 7 Jun 2011.
- Derived from this study: PubMed 24829756Yuan J, Ku GY, Adamow M, Mu Z, Tandon S, Hannaman D, Chapman P, Schwartz G, Carvajal R, Panageas KS, Houghton AN, Wolchok JD. Immunologic responses to xenogeneic tyrosinase DNA vaccine administered by electroporation in patients with malignant melanoma. J Immunother Cancer. 2013 Nov 18;1:20. doi: 10.1186/2051-1426-1-20. eCollection 2013.
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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.
Jedd D. Wolchok, MD, PhD principal investigator
Memorial Sloan Kettering Cancer 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 Xenogeneic Tyrosinase DNA Vaccine and TriGrid Delivery System for Intramuscular Electroporation in people with Melanoma (Skin) and Intraocular Melanoma, run by Ichor Medical Systems Incorporated at 1 site in United States.
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 12 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 7 Jun 2011. 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 United States. 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?
Evaluate the safety and feasibility of electroporation mediated intramuscular delivery of a mouse tyrosinase plasmid DNA vaccine in patients with stage IIB, IIC, III, or IV melanoma. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00471133, which also lists 1 linked publication.
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 7 Jun 2011.