Vorinostat and Azacitidine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00392353
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Acute Erythroid Leukemia
  • Acute Megakaryoblastic Leukemia
  • Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndrome With Excess Blasts
  • Myelodysplastic Syndrome With Ring Sideroblasts
  • Recurrent Adult Acute Myeloid Leukemia
  • Refractory Anemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Given SC
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Vorinostat — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Nov 22, 2006
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
135 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (azacitidine, vorinostat)
    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.

Primary Outcome Measure

Incidence of toxicities of vorinostat in combination with azacitidine graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 (Phase I) [ Time Frame: Up to 1 month post-treatment ]

Locations (7)

FacilityCityStateZIPSite coordinators
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
University of Maryland/Greenebaum Cancer CenterBaltimoreMaryland21201-
North Shore University HospitalManhassetNew York11030-
Mount Sinai HospitalNew YorkNew York10029-
NYP/Weill Cornell Medical CenterNew YorkNew York10065-
Montefiore Medical Center - Moses CampusThe BronxNew York10467-
Montefiore Medical Center-Weiler HospitalThe BronxNew York10461-

Find similar trials in Chicago, IL

By research site
University of Chicago Comprehensive Cancer Center· Chicago, ILUniversity of Maryland/Greenebaum Cancer Center· Baltimore, MDNorth Shore University Hospital· Manhasset, NYMount Sinai Hospital· New York, NYNYP/Weill Cornell Medical Center· New York, NYMontefiore Medical Center - Moses Campus· The Bronx, NY

Related Studies