Evaluation of Disulfiram in Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy, Phase I/II
- Subjects must be between the ages of 18 and 80.
- Patient must have pathologically proven and surgically incurable malignant melanoma,
which is Stage IV.
- Patient must have bidimensionally measurable disease. All measurable lesions must be
assessed (by physical examination, CT scan, radionuclide scan or plain X-ray) within
28 days prior to registration. Non-measurable sites must be assessed within 42 days
prior to registration. The patient's disease status must be completely assessed and
- All patients must undergo a CT of abdomen and chest within 28 days prior to
- All patients must undergo either a CT or MRI of the brain within 28 days of
registration. Patients with or without brain metastasis are both recruited for this
- Patients must have received at least one prior systemic therapy (chemotherapy,
biologic/immunotherapy, or a combination regimen) for metastatic disease. Prior
systemic therapy must have been completed at least 28 days before registration.
- Patients may have received prior biologic or immunotherapy given in an adjuvant
fashion. Prior adjuvant therapy must have been completed at least 28 days prior to
- Patients may have received prior radiation therapy. If all known sites of disease
have been previously radiated, there must be objective evidence of progression for
the patient to be eligible. Radiation therapy must have been completed at least 28
days before registration.
- Patients may have received prior surgery. Prior surgery must have been completed at
least 28 days before registration.
- Performance status must be 0-2 according to Zubrod Criteria.
- If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next
- Patients must be informed of the investigational nature of this study and sign and
give written informed consent in accordance with institutional and federal
- Patients with severe myocardial disease or coronary occlusion, psychoses, and
hypersensitivity to disulfiram or other thiuram derivatives used in pesticides and
rubber vulcanization are excluded from the study.
- Patients who cannot abstain from alcohol intake during the entire duration of this
protocol are not qualified for this study.
- Patients requiring ongoing therapy with other investigational drugs are excluded.
- Pregnant or nursing women are not eligible to participate in this trial because the
safe use of this drug in pregnancy has not been established.