Injection of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Mouse gp100 DNA: A Pilot Study to Compare Intramuscular Jet Injection With Particle Mediated Delivery
Injection of AJCC Stage IIB, IIC, III and IV Melanoma Patients With Mouse gp100 DNA: A Pilot Study to Compare Intramuscular Jet Injection With Particle Mediated Delivery
RATIONALE: Vaccines made from DNA may help the body build an effective immune response to kill tumor cells. Giving the vaccine in different ways may make a stronger immune response and kill more tumor cells.
PURPOSE: This randomized clinical trial is studying two different ways of giving vaccine therapy to compare how well they work in treating patients with stage IIB, stage IIC, stage III, or stage IV melanoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, pilot study. Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed periodically for 1 year.
DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma
Stage IIB, IIC, III, or IV disease
Patients free of disease after surgical resection must meet 1 of the following criteria:
Patients with stage IIB, IIC, or III disease must have already undergone initial standard therapy (i.e., surgery) for the disease
Choroidal (uveal) melanoma allowed provided 1 of the following criteria is met:
HLA-A*0201 positive
Negative serum antidouble-stranded DNA antibody screen
No known brain metastases
PATIENT CHARACTERISTICS:
Karnofsky performance status 80-100%
Platelet count ≥ 100,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
WBC ≥ 3,000/mm^3
Lactic dehydrogenase ≤ 2 times upper limit of normal (ULN)
Creatinine ≤ 2.0 mg/dL
Bilirubin ≤ 2.5 times ULN
Albumin ≥ 3.5 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Weight ≥ 25 kg
No preexisting choroidal eye disease
No serious underlying medical conditions that could be exacerbated by study participation (i.e., active infections requiring antimicrobial drugs or active bleeding)
No allergy to gold (i.e., gold jewelry)
No evidence of any condition at the proposed site(s) of vaccine administration that might interfere with the interpretation of local skin reactions, including any of the following:
No prior medical condition or use of medication (e.g., corticosteroids) that might make it difficult for the patient to complete the full course of treatment or to respond immunologically to vaccines
No history or evidence (within the past 5 years) of a physician-diagnosed chronic or recurrent inflammatory skin disease at the proposed site of vaccine administration, including any of the following:
No history of keloid formation
PRIOR CONCURRENT THERAPY: