Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma.

Phase II Randomized Study of High Dose Interleukin-2 Versus Stereotactic Body Radiation (SBRT) and High Dose Interleukin-2 (IL-2) in Patients With Metastatic Melanoma

The purpose of this study is compare the response rates in patients with metastatic melanoma treated with high-dose IL-2 to patients treated with high-dose IL-2 along with radiation therapy.

All patients will receive high-dose IL-2. Half the patients enrolled will be randomly selected to receive radiation therapy to up to three tumors prior to receiving high-dose IL-2. Among the first 20 patients enrolled, those assigned to receive radiation will receive a single dose of radiation and for patients 21-44, those assigned to receive radiation will receive 2 doses of radiation.

Inclusion Criteria:

• Histological confirmation of melanoma will be required by previous biopsy or cytology.
• Patients must be ≥ 18 years of age.
• Patients must have tumors amenable to SBRT in lungs, mediastinum, chest wall, bones (other than long bones), or liver (inclusive of immediately adjacent masses), 1 - 3 foci; no minimum size, but none greater than 7 cm. Patients may have other metastases but only a maximum of 3 will be treated.
• ECOG performance status of 0-1.
• Women of childbearing potential must have a serum or urine pregnancy test performed within 72 hours prior to the start of protocol treatment. The results of this test must be negative in order for the patient to be eligible. In addition, women of childbearing potential as well as male patients must agree to take appropriate precautions to avoid pregnancy.
• Patients must sign a study-specific consent form.

Exclusion Criteria:

• No metastatic site amenable to SBRT.
• Patients with brain metastases not candidates for radiosurgery.
• Previous radiation to sites proposed for radiation as part of this study.
• Patients with active systemic, pulmonary, or pericardial infection.
• Pregnant or lactating women.
• Evidence of ischemia on exercise tolerance test, stress thallium study, or baseline EKG.
• DLCO, FEV1 or FEV1/FVC less than 70% of predicted due to clinically significant underlying pulmonary disease. For any pulmonary function test values less than predicted values, the PI will review, and document the patient's suitability for high dose IL-2 therapy.
• WBC < 3.0 x 109/L
• Hgb < 9.0 g/dL
• AST/ALT > 3 times the upper limit of the normal range
• total bilirubin > 1.9 g/dL
• creatinine > 1.9 g/dL
• Patient requires chronic steroids.