Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation
June 3, 2011 updated by: Ichor Medical Systems Incorporated
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10021
- Memorial Sloan Kettering Cancer Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Xenogeneic Tyrosinase
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assess patients with measurable tumor for evidence of anti-tumor response following immunization.
Time Frame: 6 months
|
6 months
|
|
Assess the magnitude and frequency of tyrosinase specific immunologic responses in the immunized patients
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jedd D. Wolchok, MD, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
May 8, 2007
First Submitted That Met QC Criteria
May 8, 2007
First Posted (Estimate)
May 9, 2007
Study Record Updates
Last Update Posted (Estimate)
June 7, 2011
Last Update Submitted That Met QC Criteria
June 3, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.