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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00217646 |
Purpose
RATIONALE: Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of two different schedules of sorafenib in treating patients with refractory or relapsed acute leukemia, myelodysplastic syndromes, or blastic phase chronic myelogenous leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes |
Drug: sorafenib tosylate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Phase I Study of BAY 43-9006 (NSC 724772) in Patients With Acute Leukemias, Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase |
| Estimated Enrollment: | 36 |
| Study Start Date: | October 2005 |
| Estimated Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, dose-escalation study. Patients are randomized to 1 of 2 treatment arms.
In both arms, cohorts of 3-6 patients receive escalating doses of sorafenib 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. Up to 10 patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 36 patients (18 per treatment arm) will be accrued for this study within 10-18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Acute myeloid leukemia
Blastic phase chronic myelogenous leukemia
Must have failed prior therapy with ≥ 1 cytotoxic- or biologic-targeted agent (e.g., hypomethylating agents, farnesyl transferase inhibitors, thalidomide, or tyrosine kinase inhibitors)
PATIENT CHARACTERISTICS:
Age
Performance status
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Endocrine therapy
Surgery
Other
No concurrent therapeutic anticoagulation
No concurrent cytochrome P450 enzyme-inducing antiepileptic agents, including, but not limited to, any of the following:
Contacts and Locations| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| Principal Investigator: | Jorge Cortes, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000442847, MDA-2004-0702, NCI-6742 |
| Study First Received: | September 20, 2005 |
| Last Updated: | June 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00217646 History of Changes |
| Health Authority: | Unspecified |
|
recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia 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) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes secondary acute myeloid leukemia blastic phase chronic myelogenous leukemia |
adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) adult acute megakaryoblastic leukemia (M7) adult acute minimally differentiated myeloid leukemia (M0) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myelomonocytic leukemia (M4) adult acute promyelocytic leukemia (M3) adult acute basophilic leukemia adult acute eosinophilic leukemia |
|
Blast Crisis Disease Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Precancerous Conditions Antineoplastic Agents Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Enzyme Inhibitors Leukemia, Myeloid Protein Kinase Inhibitors |
Pharmacologic Actions Leukemia Preleukemia Neoplasms Neoplastic Processes Pathologic Processes Therapeutic Uses Syndrome Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Sorafenib Cell Transformation, Neoplastic |