Sorafenib in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndro… (NCT00217646) | Clinical Trial Compass
CompletedPhase 1
Sorafenib in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndromes, or Blastic Phase Chronic Myelogenous Leukemia
United States36 participantsStarted 2005-10
Plain-language 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 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* Cytopenias secondary to multilineage bone marrow failure allowed
* Ineligible for or not willing to undergo allogeneic stem cell trans…
What they're measuring
1
Maximum tolerated dose (MTD) assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0