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Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation

Primary Purpose

Melanoma (Skin), Intraocular Melanoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Xenogeneic Tyrosinase DNA Vaccine
TriGrid Delivery System for Intramuscular Electroporation
Sponsored by
Ichor Medical Systems Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring melanoma, DNA vaccine, tyrosinase, electroporation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xenogeneic Tyrosinase

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Assess patients with measurable tumor for evidence of anti-tumor response following immunization.
Assess the magnitude and frequency of tyrosinase specific immunologic responses in the immunized patients

Full Information

First Posted
May 8, 2007
Last Updated
June 3, 2011
Sponsor
Ichor Medical Systems Incorporated
Collaborators
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT00471133
Brief Title
Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation
Official Title
A Phase Ia/Ib Study of the Safety and Immunogenicity of a Xenogeneic Tyrosinase DNA Vaccine Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ichor Medical Systems Incorporated
Collaborators
Memorial Sloan Kettering Cancer Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin), Intraocular Melanoma
Keywords
melanoma, DNA vaccine, tyrosinase, electroporation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xenogeneic Tyrosinase
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Xenogeneic Tyrosinase DNA Vaccine
Intervention Type
Device
Intervention Name(s)
TriGrid Delivery System for Intramuscular Electroporation
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Assess patients with measurable tumor for evidence of anti-tumor response following immunization.
Time Frame
6 months
Title
Assess the magnitude and frequency of tyrosinase specific immunologic responses in the immunized patients
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jedd D. Wolchok, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24829756
Citation
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.
Results Reference
derived

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Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation

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