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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 |
| 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.
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
| Study ID Numbers: | CDR0000352322, JHOC-J0357, NCI-6255 |
| Study First Received: | February 10, 2004 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00077558 History of Changes |
| 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) |
|
Blast Crisis Chronic Myelomonocytic Leukemia Refractory Anemia Preleukemia Acute Myelocytic Leukemia Acute Erythroblastic Leukemia Anemia, Refractory Leukemia, Prolymphocytic Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis Leukemia, Promyelocytic, Acute Myelodysplastic Myeloproliferative Disease Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases |
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Erythroblastic, Acute Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Fludarabine Di Guglielmo's Syndrome Leukemia, Monocytic, Acute Antimetabolites Leukemia, Lymphoid Precancerous Conditions Immunologic Factors Acute Myelomonocytic Leukemia |
|
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immunologic Factors Precancerous Conditions Antineoplastic Agents Hematologic Diseases Physiological Effects of Drugs Myelodysplastic Syndromes Myeloproliferative Disorders |
Fludarabine monophosphate Immunosuppressive Agents Pharmacologic Actions Leukemia Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Fludarabine Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases |