Phase I Study to Evaluate the Safety of Cellular Adoptive Immunotherapy Using Autologous CD4+ Antigen-Specific T Cell Clones for Patients With Metastatic Melanoma

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed metastatic melanoma

- HLA type expressing one of the following class II alleles:

- DRB1*0401

- DRB1*0404

- DRB1*1501

- DPB1*0401

- DPB1*0402

- Tumor expresses tyrosinase

- Tumor expressing NY-ESO-1 and are HLA type DP4, DP2, or DR7 allowed

- No CNS metastases

- Prior CNS involvement allowed provided there is no evidence of CNS disease at
least 2 months after treatment

PATIENT CHARACTERISTICS:

Age

- 18 to 75

Performance status

- Karnofsky 70-100%

Life expectancy

- More than 16 weeks

Hematopoietic

- WBC greater than 4,000/mm^3

- Absolute neutrophil count greater than 2,000/mm^3

- Platelet count greater than 100,000/mm^3

- Hematocrit greater than 30%

Hepatic

- SGOT no greater than 3 times upper limit of normal

- INR no greater than 1.5 due to hepatic dysfunction

- No significant hepatic dysfunction, defined as hepatic toxicity grade 2 or greater

Renal

- Creatinine no greater than 2.0 mg/dL OR

- Creatinine clearance at least 60 mL/min

- Calcium no greater than 12 mg/dL

Cardiovascular

- No significant cardiac abnormalities*, defined by any 1 of the following:

- Congestive heart failure

- Clinically significant hypotension

- Symptoms of coronary artery disease

- Cardiac arrhythmias present on EKG requiring drug therapy NOTE: *Patients with a
history of cardiovascular disease or any of the above abnormalities undergo a
cardiac evaluation, including a cardiac stress test and/or echocardiogram

Pulmonary

- No clinically significant pulmonary dysfunction

- FEV1 at least 1.0 L OR

- FEV1 at least 60%

- DLCO at least 55% (corrected for hemoglobin)

Immunologic

- No acquired or hereditary immunodeficiency

- No autoimmune disease

- No active infection

- No oral temperature greater than 38.2 degrees C within the past 72 hours

- No systemic infection requiring chronic maintenance or suppressive therapy

- HIV negative

Other

- No retinitis or choroiditis

- No history of seizures

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No other concurrent immunotherapy (e.g., interleukins, interferons, melanoma
vaccines, IV immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or
lymphokine-activated killer therapy)

Chemotherapy

- At least 4 weeks since prior chemotherapy (standard or experimental) and recovered

Endocrine therapy

- No concurrent systemic steroids except for toxicity management

Radiotherapy

- At least 4 weeks since prior radiotherapy

Surgery

- Not specified

Other

- At least 4 weeks since prior immunosuppressive therapy

- More than 4 weeks since prior experimental drugs and recovered

- No concurrent pentoxifylline

- No other concurrent investigational agents