Status:
COMPLETED
Disulfiram in Patients With Metastatic Melanoma
Lead Sponsor:
John P. Fruehauf
Conditions:
Stage IV Melanoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
Melanoma remains a malignancy that is largely resistant to chemotherapy. Metastatic disease responds poorly to the treatments used today with only 2 out of 30 drugs tested, DTIC and nitrosoureas, show...
Eligibility Criteria
Inclusion
- 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 reported.
- All patients must undergo a CT of abdomen and chest within 28 days prior to registration.
- 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 protocol.
- 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 registration
- 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 working day.
- Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00256230
Start Date
January 1 2002
End Date
August 1 2007
Last Update
December 8 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868