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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00462787 |
RATIONALE: Drugs used in chemotherapy, such as clofarabine, topotecan, vinorelbine, thiotepa, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when given together with topotecan, vinorelbine, thiotepa, and dexamethasone in treating young patients with relapsed or refractory acute leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: clofarabine Drug: dexamethasone Drug: filgrastim Drug: thiotepa Drug: topotecan hydrochloride Drug: vinorelbine ditartrate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | A Phase I Dose Escalation Trial of Clofarabine in Addition to Topotecan, Vinorelbine, Thiotepa, and Dexamethasone in Pediatric Patients With Relapsed or Refractory Acute Leukemia |
Estimated Enrollment: | 18 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a nonrandomized, prospective, dose-escalation study of clofarabine.
Patients receive topotecan hydrochloride IV continuously over 120 hours on days 0-4; vinorelbine ditartrate over 6-10 minutes on days 0, 7, and 14; thiotepa IV over 4 hours on day 2; clofarabine IV over 2 hours on days 3-7; and oral or IV dexamethasone 3 times daily on days 3 and 7-13. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 8 and continuing until blood counts recover. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
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 at which 2 of 6 patients experience dose-limiting toxicity OR the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.
After completion of study treatment, patients are followed once a week for 4 weeks, twice a month for 6 months, and then once a month for 2 years.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
Ages Eligible for Study: | up to 20 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must have 1 of the following diagnoses:
Acute lymphoblastic leukemia (ALL) meeting 1 of the following criteria:
Acute myeloid leukemia, acute biphenotypic leukemia, or acute undifferentiated leukemia meeting 1 of the following criteria:
No symptomatic CNS disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 2 weeks since prior systemic chemotherapy
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Peter G. Steinherz, MD 212-639-7951 |
Principal Investigator: | Peter G. Steinherz, MD | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Neerav Shukla, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000539465, MSKCC-07012 |
Study First Received: | April 18, 2007 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00462787 |
Health Authority: | Unspecified |
acute undifferentiated leukemia recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia |
Dexamethasone Clofarabine Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Acute myelogenous leukemia Vinblastine Leukemia, Myeloid Leukemia, Myeloid, Acute |
Recurrence Thiotepa Leukemia Vinorelbine Topotecan Acute myelocytic leukemia Dexamethasone acetate |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Therapeutic Uses Alkylating Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Mitosis Modulators Gastrointestinal Agents |
Enzyme Inhibitors Antimitotic Agents Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Neoplasms Autonomic Agents Tubulin Modulators Myeloablative Agonists Peripheral Nervous System Agents Antineoplastic Agents, Alkylating Central Nervous System Agents Antineoplastic Agents, Phytogenic |