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Proteasome Inhibitor

Bortezomib + Sorafenib + Decitabine for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Alison R Walker

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have histologically or cytologically confirmed acute myeloid leukemia (AML) by World Health Organization (WHO) criteria in the blood and/or marrow AND age >= 60 and not candidates/refuse standard induction treatment OR who have one of the following: poor risk cytogenetics, AML following antecedent hematologic disorder, or therapy-related AML

Patients with relapsed or refractory AML age >= 18 years are also eligible for treatment; patients may have been treated for antecedent hematologic disorder with myeloid growth factors, recombinant erythropoietin, thalidomide, lenalidomide, 5-azacitidine or the 5 day schedule of decitabine; patients who have received the 10 day schedule of decitabine for treatment an antecedent hematologic disorder or AML are not eligible

Must not have

Patients with active central nervous system disease or with granulocytic sarcoma as sole site of disease

Patients with pre-existing grade 2 or higher neuropathy or other serious neurologic toxicity that would significantly increase risk of complications from bortezomib therapy are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to up to day 12 of course 1

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing bortezomib and sorafenib tosylate given with decitabine to see what effects (good and bad) it has on patients with acute myeloid leukemia, and to find the best dose of the drugs to use.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include reactions related to enzyme inhibition that might affect cell growth elsewhere in the body, typical chemotherapy-related issues like nausea, fatigue, blood disorders; organ inflammation; possible infection risks due to immune system impact; and nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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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.

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

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I can take care of myself and am up and about more than half of my waking hours.

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I agree to use effective birth control or remain abstinent during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have severe nerve damage or serious neurological issues.

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I do not have an advanced solid tumor.

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I have a GI condition that affects how my body absorbs medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to up to day 12 of course 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to up to day 12 of course 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to up to day 12 of course 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

BETD of bortezomib, sorafenib tosylate, and decitabine using National Cancer Institute Common Terminology Criteria for Adverse Events version 4

Secondary study objectives

CR rate

Change in miR-29b expression in blood and bone marrow

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (bortezomib, sorafenib tosylate, decitabine)Experimental Treatment5 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bortezomib

2005

Completed Phase 3

~1410

Decitabine

2004

Completed Phase 3

~1720