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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00131989 |
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 phase I trial is studying the side effects and best dose of sorafenib in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, or chronic myelogenous leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: sorafenib tosylate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I Dose Escalation Trial of the Raf Kinase Inhibitor BAY 43-9006 (NSC #724772) as Single Agent for Adults With Relapsed and Refractory Acute Leukemias and Chronic Myeloid Leukemia in Blast Crisis |
Estimated Enrollment: | 48 |
Study Start Date: | June 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, dose-escalation study.
Patients receive oral sorafenib twice daily on days 1-14 or 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete remission (CR) may be considered for retreatment with sorafenib for up to an additional 6 courses upon disease recurrence provided the duration of CR is longer than 1 month.
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 which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 12 patients are treated at the MTD.
After completion of study treatment, patients are followed monthly for up to 1 year.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study within 16-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed hematologic malignancy of 1 of the following types:
Total peripheral blood blast count < 30,000/mm^3
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation
No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs, including any of the following:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 |
Study Chair: | B. Douglas Smith, MD | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000438710, JHOC-J-0509, NCI-6745 |
Study First Received: | August 16, 2005 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00131989 |
Health Authority: | United States: Food and Drug Administration |
recurrent adult acute lymphoblastic leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) recurrent adult acute myeloid leukemia adult acute basophilic leukemia adult acute eosinophilic 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) relapsing chronic myelogenous leukemia blastic phase chronic myelogenous leukemia |
Leukemia, Monocytic, Acute Blast Crisis Leukemia, Lymphoid Chronic myelogenous leukemia Acute myelomonocytic leukemia Di Guglielmo's syndrome Leukemia, Myeloid, Acute Acute lymphoblastic leukemia, adult Leukemia Acute erythroblastic leukemia Acute myeloid leukemia, adult Congenital Abnormalities Lymphoma Acute myelocytic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Immunoproliferative Disorders Hematologic Diseases Myeloproliferative Disorders Acute myelogenous leukemia Leukemia, Myeloid Recurrence Leukemia, Myelomonocytic, Acute Lymphatic Diseases Leukemia, Erythroblastic, Acute Leukemia, Myelogenous, Chronic, BCR-ABL Positive Lymphoproliferative Disorders Bone Marrow Diseases Sorafenib Acute monoblastic leukemia |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |