Injection of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Mouse Tyrp2 DNA: A Phase I Trial to Assess Safety and Immune Response
- For all patients, pathology slides must be reviewed by the Memorial Hospital
Department of Pathology for confirmation of melanoma diagnosis.
- Patients must be HLA-A*0201 positive.
- Patients must have a Karnofsky performance status of at least 80.
- Patients must be free of detectable brain metastases.
- Patients must have adequate organ and marrow function as defined below:
- WBC ≥ than or = to 3,000/μL
- Absolute neutrophil count ≥ than or = to 1,500/μL
- Platelets ≥ than or = to 100,000/μL
- Total bilirubin ≤ than or = to 1.5X upper normal institutional limits
- LDH ≤ than or = to 2 X institutional upper limit of normal
- Albumin ≥ than or = to 3.5 mg/dl
- Creatinine ≤ than or = to 2.0 mg/dl
- Hemoglobin ≥ than or = to 10 Gm/dl
- Liver AST, ALT ≤ than or = to 2.5 x ULN
- Patients must have no known HIV positivity
- Pediatric patients are eligible if weight is > 25 kg and parent/guardian completes
informed assent process.
- Patients must understand and sign an informed consent and have specifically declined
all standard or approved therapies for which they would be considered eligible.
Parent or legal guardians of patients who are minors will sign the informed consent
- As part of the consent process, patients must agree to use contraception while on
- Patients who have had chemotherapy, immunotherapy or radiotherapy within 4 weeks
prior to entering the study or those who have not recovered from adverse events due
to agents administered more than 4 weeks earlier. For nitrosoureas, at last six weeks
must have elapsed.
- Patients with Grade I fever, active infection, or antibiotics within 72 hours prior
- Patients who have previously been immunized with any class of vaccine containing
TYRP2, including whole cell, shed antigen or cell lysate vaccine.
- Patients with a history of collagen vascular, rheumatological, or other autoimmune
- Any medical condition or use of medication (e.g., corticosteroids) which might make
it difficult for the patient to complete the full course of treatments or to respond
immunologically to vaccines is grounds for exclusion, at the discretion of the
Principal Investigator or co-Principal Investigators.
- Patients who have preexisting retinal or choroidal eye disease.
- Patients with serious underlying medical conditions that could be exacerbated by
participation, active infections requiring antimicrobial drugs or active bleeding.
- Pregnant women or women who are nursing are not eligible. Women of child-bearing
potential and sexually active men must be using appropriate contraception during the
course of this study. Women of child-bearing potential must not be pregnant (negative
βHCG within 2 weeks of immunization) nor be nursing during treatment.
- Patients receiving other investigational agents.