Bortezomib + Sorafenib + Decitabine for Acute Myeloid Leukemia
Trial Summary
What is the purpose of this trial?
This phase I trial studies the side effects and the best dose of bortezomib and sorafenib tosylate when given together with decitabine in treating patients with acute myeloid leukemia. Bortezomib and sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bortezomib and sorafenib tosylate together with decitabine may work better in treating acute myeloid leukemia.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you cannot participate if you are taking medications that strongly interact with the trial drugs. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug combination Bortezomib, Sorafenib, and Decitabine for treating Acute Myeloid Leukemia?
Research shows that Decitabine, one of the drugs in the combination, has been effective in improving survival and response rates in patients with Acute Myeloid Leukemia (AML), especially those who are not eligible for standard chemotherapy. Although adding Bortezomib to Decitabine did not improve outcomes in one study, Decitabine alone has shown promise as a treatment option for AML.12345
Is the combination of Bortezomib and Decitabine safe for treating acute myeloid leukemia?
In a study with older patients with acute myeloid leukemia, adding Bortezomib to Decitabine did not lead to unexpected toxicities, and the most common side effect was febrile neutropenia (fever with low white blood cell count). Decitabine alone has been generally well tolerated in patients with acute myeloid leukemia.13456
What makes the drug combination of Bortezomib, Sorafenib, and Decitabine unique for treating acute myeloid leukemia?
This drug combination is unique because it combines Bortezomib, a proteasome inhibitor, with Sorafenib, a kinase inhibitor, and Decitabine, a hypomethylating agent, potentially offering a multi-targeted approach to treat acute myeloid leukemia, which is different from traditional chemotherapy regimens that typically focus on a single mechanism of action.13789
Research Team
Alison R. Walker
Principal Investigator
Ohio State University Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults with acute myeloid leukemia (AML) who are either aged 60+ and can't have standard treatment, or those with high-risk AML types. It's also open to adults 18+ with relapsed/refractory AML. Participants need a performance status of <=2, acceptable liver/kidney function, no severe heart disease or active central nervous system involvement, and must agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive bortezomib, sorafenib tosylate, and decitabine in a dose-escalation study. Treatment repeats every 28 days for up to 4 courses.
Maintenance Therapy
Patients achieving complete response or incomplete complete response receive maintenance therapy with decitabine.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
Treatment Details
Interventions
- Bortezomib
- Decitabine
- Sorafenib Tosylate
Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
- Multiple myeloma
- Mantle cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor