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| Descriptive Information Fields | |||||
| Brief Title † | Decitabine in Treating Patients With Advanced Solid Tumors | ||||
| 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 | ||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: 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. |
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| Detailed Description | OBJECTIVES:
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. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Bladder Cancer Breast Cancer Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific |
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| Intervention † | Drug: decitabine | ||||
| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 24 | ||||
| Start Date † | February 2002 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00030615 | ||||
| Organization ID | CDR0000069182 | ||||
| Secondary IDs †† | LAC-USC-0C0101, NCI-5353 | ||||
| Study Sponsor † | Norris Comprehensive Cancer Center | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | March 2006 | ||||
| First Received Date † | February 14, 2002 | ||||
| Last Updated Date | September 22, 2008 | ||||