A Phase Ia/Ib Study of the Safety and Immunogenicity of a Xenogeneic Tyrosinase DNA Vaccine Melanoma
18 Years
N/A
Both
Melanoma (Skin), Intraocular Melanoma
Trial Information
A Phase Ia/Ib Study of the Safety and Immunogenicity of a Xenogeneic Tyrosinase DNA Vaccine Melanoma
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Outcome Time Frame:
one year
Safety Issue:
Yes
Principal Investigator
Jedd D. Wolchok, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
07-003
NCT ID:
NCT00471133
Start Date:
April 2007
Completion Date:
May 2010
Related Keywords:
- Melanoma (Skin)
- Intraocular Melanoma
- melanoma
- DNA vaccine
- tyrosinase
- electroporation
- Melanoma
- Uveal Neoplasms
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
