Vorinostat + Azacitidine for Myelodysplastic Syndrome / Acute Myeloid Leukemia

Palo Alto (17 mi)

Overseen byLewis R Silverman

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I/II trial studies the side effects and best dose of vorinostat and azacitidine and to see how well they work in treating patients with myelodysplastic syndromes or acute myeloid leukemia. Vorinostat may stop the growth of cancer or abnormal cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer or abnormal cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving vorinostat together with azacitidine may kill more cancer or abnormal cells.

Eligibility Criteria

This trial is for adults with certain types of blood disorders, including various forms of leukemia and myelodysplastic syndromes. Participants should have specific disease characteristics, not be on certain medications recently, and must have a life expectancy over 2 months. They need to be in relatively good health otherwise (ECOG <=2), with normal organ function tests. Pregnant women or those who've had recent cancer treatments are excluded.

Inclusion Criteria

I have AML and haven't used certain medications recently.

I have been diagnosed with MDS or AML according to specific medical criteria.

My AML is new or evolved from MDS and is not likely to respond well to treatment.

I have a type of anemia related to my bone marrow disorder.

Exclusion Criteria

I haven't had chemotherapy, radiotherapy, or been diagnosed with another cancer in the last 3 years.

I do not have brain involvement, allergies to study drugs, serious illnesses, heart failure, high myeloblasts, HIV, infections, or liver tumors.

Treatment Details

The study is testing the combination of two drugs: Vorinostat and Azacitidine. It aims to find the safest doses and see how effective they are against different blood disorders like acute myeloid leukemia and myelodysplastic syndromes by blocking enzymes that allow abnormal cells to grow or by directly killing them.

1Treatment groups

Experimental Treatment

Group I: Treatment (azacitidine, vorinostat)Experimental Treatment4 Interventions

Patients receive azacitidine SC QD on days 1-7 and vorinostat PO 2-3 times daily on days 3-5, 3-9, or 3-16. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

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

🇪🇺 Approved in European Union as Vidaza for: