OBJECTIVES:

• Determine the maximum tolerated dose of decitabine in patients with advanced solid tumors.
• Determine the toxic effects of this drug in these patients.
• Determine the dose of this drug with biologic activity in these patients.
• Determine the pharmacokinetics of this drug in these patients.
• Determine clinical response to this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive decitabine IV over 30 minutes on days 1-5 weekly for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of decitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: Approximately 12-24 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of advanced metastatic solid tumor for which all standard therapy has failed, including, but not limited to the following:

  • Stage III or IV melanoma

    • Mucosal melanoma allowed
    • No resectable stage III melanoma
  • Bladder cancer
  • Breast cancer
• No active symptomatic CNS disease
• No radiographically evident cerebral edema

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Male or female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Hemoglobin at least 9.0 g/dL
• Platelet count at least 100,000/mm^3
• WBC at least 3,500/mm^3
• Absolute granulocyte count at least 1,500/mm^3
• No coagulation disorders

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT and SGPT less than 2.5 times ULN
• Hepatitis B surface antigen negative
• Hepatitis C antibody negative

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No major cardiovascular system illness

Pulmonary:

• No major respiratory system illness

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No major systemic infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 1 month since prior radiotherapy

Surgery:

• Not specified

Other:

• At least 1 month since any prior anticancer therapy or adjuvant therapy
• No other experimental treatment within 30 days prior to, during, and for 30 days after study therapy