Decitabine in Treating Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Male Breast Cancer, Recurrent Bladder Cancer, Recurrent Breast Cancer, Recurrent Melanoma, Stage III Melanoma, Stage IV Bladder Cancer, Stage IV Breast Cancer, Stage IV Melanoma, Unspecified Adult Solid Tumor, Protocol Specific

In brief

This phase I trial is studying the side effects and best dose of decitabine in treating patients with advanced solid tumors that have not responded to previous treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Key facts

Study ID: NCT00030615
Run by: National Cancer Institute (NCI)
People needed: 24
Starts: 2001-12-01
Last updated by the study team: 2013-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Male or female
Performance status - ECOG 0-1
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
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
Creatinine no greater than 1.5 times ULN
No major cardiovascular system illness
No major respiratory system illness
Not pregnant or nursing

Where it is running

University of Southern California — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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