Trials / Completed
CompletedNCT00217646
Sorafenib in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndromes, or Blastic Phase Chronic Myelogenous Leukemia
Phase I Study of BAY 43-9006 (NSC 724772) in Patients With Acute Leukemias, Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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, or blastic phase chronic myelogenous leukemia. II. Determine the dose-limiting toxicity of this drug in these patients. SECONDARY OBJECTIVES: I. Determine the clinical activity of this drug in these patients. II. Determine the biologic effect of this drug in these patients. OUTLINE: This is a randomized, dose-escalation phase I study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral sorafenib once or twice daily on days 1-5, 8-12, and 15-19. Arm II: Patients receive oral sorafenib once or twice daily on days 1-14. In both arms, treatment repeats every 21 days for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission or partial remission after 6 months may continue therapy at the discretion of the principal investigator. 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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sorafenib Tosylate | Given orally |
Timeline
- Start date
- 2005-10-01
- Primary completion
- 2010-12-01
- First posted
- 2005-09-22
- Last updated
- 2015-04-28
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00217646. Inclusion in this directory is not an endorsement.