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Evaluation of Disulfiram in Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy, Phase I/II


Phase 1/Phase 2
18 Years
80 Years
Not Enrolling
Both
Stage IV Melanoma

Thank you

Trial Information

Evaluation of Disulfiram in Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy, Phase I/II


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine response rate

Outcome Description:

Complete response (CR)-Complete disappearance of all measurable and evaluable disease. No disease related symptoms. No evidence of non-evaluable disease, including normalization of markers and other abnormal lab values. Partial response (PR)-Applies only to patients with at least one measurable lesion. Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. For both CR and PR, no new lesions. All assessments use the same techniques as baseline.

Outcome Time Frame:

Every 8 weeks during therapy

Safety Issue:

Yes

Principal Investigator

John Fruehauf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UCI 01-01

NCT ID:

NCT00256230

Start Date:

January 2002

Completion Date:

August 2007

Related Keywords:

  • Stage IV Melanoma
  • Melanoma

Name

Location

Chao Family Comprehensive Cancer CenterOrange, California  92868