Status:
COMPLETED
Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation
Lead Sponsor:
Ichor Medical Systems Incorporated
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Conditions:
Melanoma (Skin)
Intraocular Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00471133
Start Date
April 1 2007
End Date
May 1 2010
Last Update
June 7 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021