Bortezomib + Sorafenib + Decitabine for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

Overseen by Alison R. Walker

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

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.

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

I am 60 or older with AML and cannot or choose not to undergo standard treatment, or I have high-risk AML.

I am 18 or older with AML that has come back or didn't respond to treatment, and I haven't been treated with a 10-day decitabine schedule.

My kidney function is normal, with creatinine levels below 2.0 mg/dL or clearance above 60 mL/min.

Exclusion Criteria

I haven't had chemotherapy or radiotherapy in the last 2 weeks.

I do not have any severe illnesses or heart problems that my doctor says are uncontrolled.

I have active brain disease or my only cancer is in my granulocytes.

Participant Groups

The trial tests the combination of bortezomib and sorafenib tosylate with decitabine in treating AML. Bortezomib/sorafenib may halt cancer cell growth by blocking enzymes they need, while decitabine could kill or stop cancer cells from dividing/spreading. The study aims to find the best dose and assess side effects.

Group I: Treatment (bortezomib, sorafenib tosylate, decitabine) Experimental Treatment 5 Interventions

STEP A: Patients receive bortezomib SC on days 1 and 4, sorafenib tosylate PO BID on days 1-14, and decitabine IV over 1 hour on days 5-14. STEP B: Patients receive bortezomib SC on days 1, 4, and 8 or 1, 4, 8 and 11, sorafenib tosylate PO BID on days 1-14, and decitabine IV over 1 hour on days 9-18 or 12-21. STEP C: Patients receive bortezomib SC on days 1, 4, and 8 or 1, 4, 8 and 11, sorafenib tosylate PO BID on days 1-14, and decitabine IV over 1 hour on days 5-14. Treatment repeats every 28 days for up to 4 courses in the absence of unacceptable toxicity. Patients achieving CR or CRi receive maintenance therapy comprising decitabine IV on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Bortezomib is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

🇺🇸 Approved in United States as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

🇨🇦 Approved in Canada as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

🇯🇵 Approved in Japan as Velcade for:

• Multiple myeloma
• Mantle cell lymphoma

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ohio State University Comprehensive Cancer Center Columbus, OH

Who Is Running the Clinical Trial?

National Cancer Institute (NCI) Lead Sponsor

References