RFT-5-dgA in Patients With Metastatic Melanoma

* INCLUSION CRITERIA:

  1. Patients age greater than 18 with measurable metastatic melanoma that have an expected survival of greater than three months will be considered. Patients with resectable local/regional disease would undergo standard treatment with surgical resection and will not be eligible.
  2. Patients must be able to understand and give informed consent.
  3. Patients must have progressed while receiving standard therapy which may include IL-2; however, prior IL-2 therapy is not a requirement for enrollment.
  4. Serum creatinine of 1.6 mg/dl or less.
  5. Total bilirubin 2.0 mg/dl or less, except for patients with Gilbert's Syndrome who must have a total bilirubin less than 3.0 mg/dl.
  6. WBC 3000/mm(3) or greater.
  7. Platelet count 90,000 mm(3) or greater
  8. Serum albumin greater than 2.5 g/dl,
  9. Serum AST/ALT less then 2.5 times normal,
  10. ECOG performance status of 0 or 1 or 2.
  11. For patients greater than 50 years of age or who have a history of cardiovascular disease a thallium stress test is required with EF greater than or equal to 45%.
  12. Patients of both genders must be willing to practice effective birth control during this trial.
  13. Patients must be willing to undergo leukapheresis.

EXCLUSION CRITERIA:

Patients will be excluded:

1. who are undergoing or have undergone in the past 3 weeks any other systemic form of therapy for their cancer.
2. who received RFT5-dgA on another trial.
3. who have uncontrolled concurrent illness including, but not limited to: ongoing or active infection; ongoing or active cardiac disease, such as symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements.
4. who require systemic steroid therapy upon entry into the trial.
5. who are pregnant or breast-feeding.
6. who are known to be positive for hepatitis B(s)AG, hepatitis C or HIV antibody (because of possible immune effects of these conditions).
7. who require chronic anticoagulation.
8. who are 50 years old or greater who do not have a normal stress cardiac test (stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) with a LVEF less than 45%.
9. who have history of EKG abnormalities, symptoms of cardiac ischemia or arrhythmias who do not have a normal stress cardiac test (stress thallium, stress MUGA, dobutamine echocardiogram, or other stress test) with a LVEF lea than 45%.
10. who have any autoimmune diseases or immunodeficiency (including HIV),or other concurrent malignancies.
11. Who have HAMA levels greater than 1 ug/mL.
12. Who have had prior radiotherapy including radiotherapy to the lung, except for patients who have undergone localized soft tissue radiotherapy.
13. Who have extensive lung disease where greater than 15% of the lung is involved based on CT evaluation.