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Sponsors and Collaborators: |
University of Nebraska National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00503880 |
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or in peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving clofarabine and cytarabine together with G-CSF may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works when given together with cytarabine and G-CSF in treating patients with myelodysplastic syndromes.
Condition | Intervention | Phase |
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Myelodysplastic Syndromes |
Drug: clofarabine Drug: cytarabine Drug: filgrastim Procedure: biopsy Procedure: gene expression profiling |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | A Dose Escalation Phase I/II Study of Clofarabine Plus Cytarabine With Growth Factor Priming in Patients Who Are Not Felt to be Candidates for More Aggressive Treatment, With Int-2 and High-Risk MDS |
Estimated Enrollment: | 33 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a phase I, nonrandomized, dose-escalation study of clofarabine followed by a phase II study.
Cohorts of 3-6 patients receive escalating doses of clofarabine 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 dose-limiting toxicity.
Quality of life is assessed at baseline, prior to course 4, and after completion of study therapy.
Patients undergo bone marrow biopsy at baseline and prior to courses 3, 6, and 8 for evaluation of treatment response. Bone marrow samples are analyzed for myeloblast phenotypic expression profiles, which include the following parameters: percentage of CD34-positive myeloblasts; antigen expression density of CD13, CD34, CD45, and CD117; and aberrant myeloblast expression of CD4, CD11c, CD15, and CD56.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Nebraska | |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198-6805 |
Principal Investigator: | Lori J. Maness, MD | University of Nebraska |
Responsible Party: | UNMC Eppley Cancer Center at the University of Nebraska Medical Center ( Lori J. Maness ) |
Study ID Numbers: | CDR0000555504, UNMC-03207, UNMC 032-07 |
Study First Received: | July 17, 2007 |
Last Updated: | December 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00503880 |
Health Authority: | United States: Food and Drug Administration |
de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes |
Clofarabine Myelodysplastic syndromes Preleukemia Precancerous Conditions Hematologic Diseases Myelodysplasia |
Myelodysplastic Syndromes Neoplasm Metastasis Bone Marrow Diseases Aggression Cytarabine |
Antimetabolites Anti-Infective Agents Disease Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs |
Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Pathologic Processes Syndrome Therapeutic Uses |