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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00469859 |
RATIONALE: Lestaurtinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lestaurtinib together with cytarabine and idarubicin may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of lestaurtinib when given together with cytarabine and idarubicin and to see how well they work in treating younger patients with relapsed or refractory acute myeloid leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: cytarabine Drug: idarubicin Drug: lestaurtinib |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Pilot Study of Lestaurtinib (CEP-701) in Combination With Chemotherapy in Young Patients With Relapsed or Refractory FLT3-Mutant Acute Myeloid Leukemia |
Estimated Enrollment: | 37 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, dose-finding study of lestaurtinib followed by an efficacy study.
Dose-finding phase:
Cohorts of 6 patients receive escalating doses of lestaurtinib until a tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by plasma inhibitory activity (PIA) assay.
Continuation therapy: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically during study treatment for pharmacokinetic and PIA assays.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Ages Eligible for Study: | 1 Year to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of acute myeloid leukemia (AML) according to FAB classification
In first relapse after induction therapy OR refractory to induction therapy with ≤ 1 attempt at remission induction
PATIENT CHARACTERISTICS:
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age and gender as follows:
PRIOR CONCURRENT THERAPY:
No prior cumulative anthracycline doses exceeding 450 mg/m^2 daunorubicin equivalents
At least 14 days since prior cytotoxic therapy
Radiotherapy to chloromas allowed
No other concurrent chemotherapy, investigational therapy, immunomodulating agents, or steroids
No concurrent CYP3A4,5 inhibitors, including any of the following:
No concurrent CYP3A4,5 inducers, including any of the following:
Study Chair: | Patrick A. Brown, MD | Sidney Kimmel Comprehensive Cancer Center |
Investigator: | Donald Small, MD, PhD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000543398, COG-AAML06P1 |
Study First Received: | May 3, 2007 |
Last Updated: | November 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00469859 |
Health Authority: | Unspecified |
recurrent childhood acute myeloid leukemia adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities |
adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) recurrent adult acute myeloid leukemia secondary acute myeloid leukemia |
Leukemia Idarubicin Acute myelogenous leukemia Neoplasm Metastasis Acute myeloid leukemia, adult Leukemia, Myeloid |
Congenital Abnormalities Leukemia, Myeloid, Acute Acute myelocytic leukemia Cytarabine Recurrence |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents |
Physiological Effects of Drugs Antibiotics, Antineoplastic Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses |