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| Sponsor: | USC/Norris Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00030615 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bladder Cancer Breast Cancer Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific |
Drug: decitabine |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 24 |
| Study Start Date: | February 2002 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Hormone receptor status:
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:
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089-9181 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| Study Chair: | Ana Aparicio, MD | M.D. Anderson Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00030615 History of Changes |
| Other Study ID Numbers: | CDR0000069182, LAC-USC-0C0101, NCI-5353 |
| Study First Received: | February 14, 2002 |
| Last Updated: | January 10, 2009 |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer recurrent bladder cancer stage IV bladder cancer stage III melanoma |
stage IV melanoma recurrent melanoma unspecified adult solid tumor, protocol specific male breast cancer |
|
Urinary Bladder Neoplasms Breast Neoplasms Melanoma Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urinary Bladder Diseases Urologic Diseases Breast Diseases Skin Diseases Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Decitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
