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| Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00077558 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. 3-AP may help fludarabine kill more cancer cells by making them more sensitive to the drug.
PURPOSE: This phase I trial is studying the side effects and best dose of fludarabine when given together with 3-AP in treating patients with relapsed or refractory acute leukemia, chronic leukemia, or high-risk myelodysplastic syndrome.
| Condition | Intervention | Phase |
|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: fludarabine phosphate Drug: triapine |
Phase I |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| Drug Information available for: | Fludarabine Fludarabine monophosphate 3-Aminopyridine-2-carboxaldehyde thiosemicarbazone |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Trial Of Sequential Administration Of Triapine (3-Aminopyridine-2-Carboxaldehyde Thiosemicarbazone) Followed By Fludarabine In Adults With Relapsed And Refractory Leukemias And Myelodysplasias |
| Study Start Date: | January 2004 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of fludarabine. Patients are stratified according to disease (acute leukemias and myelodysplastic syndromes [MDS] vs chronic lymphocytic leukemia and prolymphocytic leukemia). Patients are assigned to 1 of 2 treatment groups.
Cohorts of 3-6 patients receive escalating doses of fludarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose level.
In both groups, treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 3-34 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:
Histologically confirmed diagnosis of 1 of the following:
High-risk myelodysplastic syndromes (MDS), including refractory anemia with excess blasts and chronic myelomonocytic leukemia
International Prognostic Scoring System (IPSS) score at least 1.5 based on the following:
Acute myeloid leukemia (AML)
Acute progranulocytic leukemia
Chronic myelogenous leukemia
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
No known glucose-6-phosphate dehydrogenase (G6PD) deficiency
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No active uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Georgia | |||||
| Blood and Marrow Transplant Group of Georgia | |||||
| Atlanta, Georgia, United States, 30342-4777 | |||||
| United States, Maryland | |||||
| Greenebaum Cancer Center at University of Maryland Medical Center | |||||
| Baltimore, Maryland, United States, 21201 | |||||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||||
| Baltimore, Maryland, United States, 21231 | |||||
| United States, Texas | |||||
| M.D. Anderson Cancer Center at University of Texas | |||||
| Houston, Texas, United States, 77030-4095 | |||||
| Sidney Kimmel Comprehensive Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Judith E. Karp, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000352322, JHOC-J0357, NCI-6255 |
| First Received: | February 10, 2004 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00077558 |
| Health Authority: | United States: Federal Government |
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