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| Sponsor: | Sidney Kimmel Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Sidney Kimmel Comprehensive Cancer Center |
| 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 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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 | |
| Study Chair: | Judith E. Karp, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00077558 History of Changes |
| Other Study ID Numbers: | CDR0000352322, J0357, U01CA070095, P30CA006973, JHOC-J0357, NCI-6255 |
| Study First Received: | February 10, 2004 |
| Last Updated: | March 9, 2010 |
| Health Authority: | United States: Federal Government |
|
accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia previously treated myelodysplastic syndromes secondary myelodysplastic syndromes refractory chronic lymphocytic leukemia recurrent adult acute lymphoblastic leukemia prolymphocytic leukemia refractory anemia with excess blasts chronic myelomonocytic leukemia recurrent adult acute myeloid leukemia secondary acute myeloid leukemia adult acute minimally differentiated myeloid leukemia (M0) adult acute monocytic leukemia (M5b) adult acute erythroid leukemia (M6) |
adult acute megakaryoblastic leukemia (M7) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) adult acute promyelocytic leukemia (M3) adult acute eosinophilic leukemia adult acute basophilic leukemia atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12) |
|
Leukemia Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Fludarabine monophosphate Vidarabine |
Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents |