Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation

This study has been completed.
Sponsor:
Collaborator:
Memorial Sloan-Kettering Cancer Center
Information provided by:
Ichor Medical Systems Incorporated
ClinicalTrials.gov Identifier:
NCT00471133
First received: May 8, 2007
Last updated: June 3, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Intraocular Melanoma
Biological: Xenogeneic Tyrosinase DNA Vaccine
Device: TriGrid Delivery System for Intramuscular Electroporation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ia/Ib Study of the Safety and Immunogenicity of a Xenogeneic Tyrosinase DNA Vaccine Melanoma

Resource links provided by NLM:


Further study details as provided by Ichor Medical Systems Incorporated:

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. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess patients with measurable tumor for evidence of anti-tumor response following immunization. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Assess the magnitude and frequency of tyrosinase specific immunologic responses in the immunized patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xenogeneic Tyrosinase Biological: Xenogeneic Tyrosinase DNA Vaccine Device: TriGrid Delivery System for Intramuscular Electroporation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471133

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Ichor Medical Systems Incorporated
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Jedd D. Wolchok, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Drew Hannaman, Ichor Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT00471133     History of Changes
Obsolete Identifiers: NCT00466427
Other Study ID Numbers: 07-003
Study First Received: May 8, 2007
Last Updated: June 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ichor Medical Systems Incorporated:
melanoma
DNA vaccine
tyrosinase
electroporation

Additional relevant MeSH terms:
Melanoma
Uveal Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Eye Neoplasms
Neoplasms by Site
Eye Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on August 25, 2014