Dacarbazine and Carmustine in Metastatic Melanoma

In this phase II trial, patients with stage IV melanoma will be treated with dacarbazine and
carmustine commonly used in this cancer, but given using a schedule that might theoretically
improve on this combination. Patients on this study will be assessed in terms of toxicity,
response rate, median duration of response, median time to disease progression, and median
survival.

Inclusion Criteria:

1. Patients must have a histologically-proven diagnosis of metastatic malignant melanoma
which has progressed on at least one prior systemic therapy.

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 and
estimated survival of at least 3 months.

3. Patients must be felt to have recovered from effects of prior cancer therapy, such as
past expected leukocyte nadir for chemotherapy (> 2 weeks).

4. Absolute granulocyte count of at least 1500/mm3; hemoglobin of at least 9 gm/dl;
platelet count of at least 100,000/mm3; bilirubin must be less than 1.5 mg/dl; ALT and
AST must be less than 3 times the upper limit of normal; creatinine must be less than
or equal to 1.8 mg/dl.

5. Women of childbearing potential must have a negative pregnancy test and adequate
precautions to prevent pregnancy during treatment must be taken.

6. Patient consent must be obtained prior to entrance onto study.

7. Patients must have no evidence of significant cardiovascular disease including history
of recent (< 6 months) myocardial infarction, uncompensated congestive heart failure,
uncontrolled angina or cerebrovascular accident.

Exclusion Criteria:

1. Evidence of significant cardiovascular disease including history of recent (< 6
months) myocardial infarction, uncompensated congestive heart failure, uncontrolled
angina, or cerebrovascular accident.

2. Prior history of psychiatric disorder that could be exacerbated by or which could
preclude completion of this therapy.

3. Pregnancy or lactation.

4. Prior chemotherapy with carmustine