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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00577694 |
RATIONALE: Drugs used in chemotherapy, such as clofarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving clofarabine together with gemtuzumab may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when given together with gemtuzumab in treating patients with relapsed or refractory acute myeloid leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: clofarabine Drug: gemtuzumab ozogamicin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | A Nonrandomized Dose-Escalation Study of Clofarabine in Combination With Gemtuzumab Ozogamicin for Relapsed/Refractory Acute Myeloid Leukemia (AML) for Patients Less Than 60 Years-Old |
Estimated Enrollment: | 18 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of clofarabine.
Patients receive induction therapy comprising clofarabine IV on days 1-5 and gemtuzumab ozogamicin IV over 2 hours on days 1, 4, and 7 during course 1 only. Beginning in course 2, after blood counts recover, patients receive consolidation therapy comprising clofarabine IV on days 1-5. Consolidation treatment repeats upon blood count recovery for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients in remission after consolidation therapy are followed monthly for the first 6 months, and then every 3-4 months for 2 years.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:
No CNS disease requiring radiotherapy
PATIENT CHARACTERISTICS:
INR ≤ 1.5 and aPTT within ULN
No cardiac disease, including any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent treatment with any other investigational agent for AML
United States, North Carolina | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7295 | |
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 |
Principal Investigator: | Thomas C. Shea, MD | UNC Lineberger Comprehensive Cancer Center |
Study ID Numbers: | CDR0000580801, UNC-LCCC-0708, UNC-LCCC-07-1222 |
Study First Received: | December 19, 2007 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00577694 |
Health Authority: | Unspecified |
recurrent adult acute myeloid leukemia |
Antibodies, Monoclonal Clofarabine Leukemia Antibodies Acute myelogenous leukemia Acute myeloid leukemia, adult |
Leukemia, Myeloid Gemtuzumab Leukemia, Myeloid, Acute Acute myelocytic leukemia Recurrence Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |