Status:
COMPLETED
Sorafenib in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndromes, or Blastic Phase Chronic Myelogenous Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Basophilic Leukemia
Adult Acute Eosinophilic Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 syndro...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of sorafenib when administered in two different schedules in patients with refractory or relapsed acute leukemia, myelodysplastic syndromes...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00217646
Start Date
October 1 2005
Last Update
April 28 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030