Sorafenib in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndromes, or Blastic Phase Chronic Myelogenous Leukemia

Completed · Phase 1

Conditions studied: Adult Acute Basophilic Leukemia, Adult Acute Eosinophilic Leukemia, Adult Acute Megakaryoblastic Leukemia, Adult Acute Monoblastic Leukemia, Adult Acute Monocytic Leukemia, Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With Maturation, Adult Acute Myeloid Leukemia With Minimal Differentiation, Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11, Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1, Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL, Adult Acute Myeloid Leukemia Without Maturation, Adult Acute Myelomonocytic Leukemia, Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA, Adult Erythroleukemia, Adult Pure Erythroid Leukemia, Alkylating Agent-Related Acute Myeloid Leukemia, Blastic Phase, de Novo Myelodysplastic Syndrome, Previously Treated Myelodysplastic Syndrome, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndrome

In brief

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. 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.

Key facts

Study ID

NCT00217646

Run by

National Cancer Institute (NCI)

People needed

36

Starts

2005-10-01

Last updated by the study team

2015-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of 1 of the following: Acute myeloid leukemia (Acute promyelocytic leukemia (M3) allowed provided patient has failed prior therapy with both tretinoin and arsenic alone or in combination); Acute lymphoblastic leukemia; Myelodysplastic syndromes; Blastic phase chronic myelogenous leukemia (Failed OR intolerant to imatinib mesylate)
• Must have failed prior therapy with >= 1 cytotoxic- or biologic-targeted agent (e.g., hypomethylating agents, farnesyl transferase inhibitors, thalidomide, or tyrosine kinase inhibitors); Any number of prior regimens allowed
• Performance status: ECOG 0-1
• ALT =< 2.5 times upper limit of normal
• Bilirubin =< 1.5 mg/dL
• Creatinine =< 2.0 mg/dL OR Creatinine clearance >= 60 mL/min
• Fertile patients must use effective contraception
• No psychiatric illness or social situation that would preclude study compliance
• Prior bone marrow transplantation allowed
• At least 2 weeks since prior cytotoxic agents OR at least 5 half-lives for non-cytotoxic agents in the absence of rapidly progressing disease
• At least 24 hours since prior hydrea for control of peripheral blood leukemia cell counts
• Hydroxyurea allowed up to 72 hours after start of therapy with sorafenib
• No persistent, chronic, clinically significant toxicities > grade 1 from prior chemotherapy

You may not qualify if…

• Cytopenias secondary to multilineage bone marrow failure allowed
• Ineligible for or not willing to undergo allogeneic stem cell transplantation OR no donor available
• Absolute blast count=< 20,000/mm\^3 unless patient has documented fms-like tyrosine kinase 3 internal tandem duplication
• No evidence of bleeding diathesis (except due to low platelets associated with the primary disease)
• No New York Heart Association class III or IV congestive heart failure
• No uncontrolled hypertension (i.e., sustained systolic blood pressure [BP] >= 150 mm Hg or diastolic BP >= 90 mm Hg)
• No unstable angina pectoris
• No symptomatic cardiac arrhythmia requiring and not responding to medical intervention
• Not pregnant or nursing
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to the study drug
• No swallowing dysfunction that would impede oral ingestion of tablets
• No active uncontrolled infection
• No other uncontrolled illness
• No prior sorafenib
• No other concurrent investigational or commercial agents, except for standard intrathecal chemotherapy for the treatment of isolated CNS leukemic involvement
• No other concurrent anticancer agents
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No concurrent therapeutic anticoagulation (Concurrent prophylactic anticoagulation [i.e., low-dose warfarin, catheter flushing with heparin] of venous or arterial access devices allowed)
• No concurrent cytochrome P450 enzyme-inducing antiepileptic agents, including, but not limited to, any of the following: Phenytoin; Carbamazepine; Phenobarbital; Rifampin
• No concurrent Hypericum perforatum (St. John's wort)

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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