Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study Of The Toxicities, Biologic And Clinical Effects Of Daily 5 Aza 2'Deoxycytidine (DAC), NSC 127716 (IND 50733) For Four Weeks In Patients With Advanced Malignancies
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
Status | Completed |
Enrollment | 24 |
Est. completion date | |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No major systemic infection - At least 1 month since prior radiotherapy - 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Southern California | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose determined by dose-limiting toxicities graded according to CTC 2.0 toxicity criteria | 6 weeks | Yes |
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