Patients With Mouse Tyrp2 DNA: A Phase I Trial to Assess Safety and Immune Response

Recruitment & Eligibility

Inclusion Criteria

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 form.
As part of the consent process, patients must agree to use contraception while on study.

Exclusion Criteria

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 to study.
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 disorders.
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.

Study & Design

Arm && Interventions

Group	Intervention	Description
1	injection of mouse TYRP2 DNA	Injection of mouse TYRP2 DNA in patients with highrisk melanoma.

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and feasibility of intra-muscular DNA injection with mouse TYRP2 DNA. Doses will be escalated by groups to determine the maximal tolerated dose.	conclusion of study

Secondary Outcome Measures

Name	Time	Method
A secondary endpoint is to observe the patients for evidence of any antitumor response generated after immunizations.	conclusion of study

Recruitment & Eligibility