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| Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00079378 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as decitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Valproic acid may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Combining decitabine with valproic acid may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of decitabine and valproic acid in treating patients with refractory or relapsed acute myeloid leukemia or previously treated chronic lymphocytic leukemia or small lymphocytic leukemia.
| Condition | Intervention | Phase |
|
Leukemia Lymphoma |
Drug: decitabine Drug: valproic acid |
Phase I |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma |
| Drug Information available for: | Divalproex sodium Valproate Sodium Valproic acid 5-Aza-2'-deoxycytidine |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase I Study of Decitabine in Combination With Valproic Acid in Patients With Selected Hematologic Malignancies |
| Estimated Enrollment: | 84 |
| Study Start Date: | March 2004 |
| Estimated Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study. Patients are stratified according to disease (refractory or relapsed acute myeloid leukemia vs chronic lymphocytic leukemia or small lymphocytic lymphoma).
Patients receive decitabine IV over 1 hour on days 1-5 or 1-10. Treatment repeats every 28 days.
Cohorts of 6 patients receive escalating doses of decitabine until the minimally effective pharmacological dose (MEPD) is determined. The MEPD is defined as the dose at which at least 5 of 6 patients meet gene methylation criteria and no more than 1 of 6 patients experiences dose-limiting toxicity (DLT).
Once the MEPD is determined, patients receive decitabine at that dose level administered as above and oral valproic acid three times daily on days 5-21. Treatment repeats every 28 days.
Cohorts of 3-6 patients receive escalating doses of valproic acid until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT. The MEPD of valproic acid is then determined using established gene methylation and toxicity criteria.
Treatment continues for up to 24 months in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 84 patients (42 per stratum) will 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 one of the following as defined by the WHO classification:
Acute myeloid leukemia (AML) (stratum I) meeting one of the following criteria:
Untreated (or previously treated but fulfilling criteria for poor prognosis) with poor-risk leukemia, defined by any of the following criteria:
Chronic lymphocytic leukemia or small lymphocytic lymphoma (stratum II) meeting the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Stratum I:
Stratum II:
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent hormonal therapy except for the following:
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Ohio | |||||
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |||||
| Columbus, Ohio, United States, 43210-1240 | |||||
| Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
| National Cancer Institute (NCI) |
| Study Chair: | Guido Marcucci, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000355412, OSU-0336, NCI-6236, OSU-2003C0094 |
| First Received: | March 8, 2004 |
| Last Updated: | July 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00079378 |
| Health Authority: | United States: Food and Drug Administration |
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