A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Metastatic Malignant Melanoma

Inclusion Criteria:

- Age greater than or equal to 18

- Karnofsky Performance Status (KFS) of greater than or equal to 70

- Laboratory values (performed in 14 days, inclusive prior to study drug
administration):

- Absolute neutrophil count (ANC) >1500/mm3

- Platelet count >100,000/mm3

- Hemoglobin > 10 g/dl

- Blood urea nitrogen (BUN) and serum creatinine < 0.5 times the upper limit of
laboratory normal

- Total and direct bilirubin < 1.5 times the upper limit of laboratory normal

- Serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic
transaminase(SGPT) < 3 times the upper limit of laboratory normal

- Alkaline phosphatase < 3 times upper limit of laboratory normal

- Life expectancy of greater than 12 weeks

- Written informed consent

Exclusion Criteria:

- No recovery from all active toxicities of prior therapies

- Surgery within 1 week prior to study drug administration, providing acute surgical
toxicity is resolved

- Subjects within acute infection treated with intravenous antibiotics

- Frequent vomiting or medical condition that could interfere with oral medication
intake (e.g., partial bowel obstruction)

- Concurrent malignancies at other sites with the exception of surgically cured
carcinoma in situ (CIS ) of the cervix, basal or squamous cell carcinoma of the skin,
and prior malignancies which have not required anit-tumor treatment within the
preceding 24 months

- Known HIV-positivity or AIDS-related illness

- Women of childbearing potential who are not using an effective method of
contraception (eligible patients must have a negative urine pregnancy test 24 hours
prior to administration of study drug and be practicing medically approved
contraceptive precautions)

- Men who do not use an effective method of contraception.

- Chemotherapy within four weeks prior to study drug administration or biologic
therapy/immunotherapy within two weeks prior to study drug administration

- Completion of radiation therapy, interstitial brachytherapy, or radiosurgery within 4
weeks prior to study drug administration (patients with brain metastases from
melanoma must have completed radiotherapy to the brain at least 3 weeks before study
commences)

- Bone metastases as sole reason for Stage IV disease

- Karnofsky Performance Status of less than or equal to 60