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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006364 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as homoharringtonine, work in different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of homoharringtonine in treating patients who have chronic phase chronic myelogenous leukemia.
| Condition | Intervention | Phase |
|
Leukemia |
Drug: homoharringtonine |
Phase II |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood |
| Drug Information available for: | Homoharringtonine |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I and Pilot Study of Subcutaneous Homoharringtonine in Chronic Myelogenous Leukemia (CML) |
| Study Start Date: | November 1999 |
OBJECTIVES:
OUTLINE: This is a pilot, dose-escalation study. (Phase I completed as of 2/11/2004.)
Cohorts of 3-6 patients receive escalating doses of homoharringtonine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. An additional cohort of 25-30 patients with chronic phase chronic myelogenous leukemia receives remission induction and maintenance therapy as above at the MTD. (Phase I completed as of 2/11/2004.)
Patients are followed every 3 months.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic phase chronic myelogenous leukemia (CML), as defined by the following:
Failed prior therapy with imatinib mesylate, as defined by any of the following:
Failed no more than 2 prior treatment regimens (in addition to imatinib mesylate)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Texas | |||||
| University of Texas - MD Anderson Cancer Center | |||||
| Houston, Texas, United States, 77030-4009 | |||||
| M.D. Anderson Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Jorge Cortes, MD | M.D. Anderson Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Quintas-Cardama A, Kantarjian H, Garcia-Manero G, O'Brien S, Faderl S, Estrov Z, Giles F, Murgo A, Ladie N, Verstovsek S, Cortes J. Phase I/II study of subcutaneous homoharringtonine in patients with chronic myeloid leukemia who have failed prior therapy. Cancer. 2007 Jan 15;109(2):248-55.
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Quintas-Cardama A, Cortes J, Verstovsek S, et al.: Subcutaneous (SC) homoharringtonine (HHT) for patients (pts) with chronic myelogenous leukemia (CML) in chronic phase (CP) after imatinib mesylate failure. [Abstract] Blood 106 (11): A-4839, 2005 .
  |
| Study ID Numbers: | CDR0000068237, MDA-ID-99032, MDA-FDR001783, NCI-T99-0044 |
| First Received: | October 4, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006364 |
| Health Authority: | United States: Federal Government |
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