Vorinostat and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

Part of paid clinical trials in Stanford, California.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT00673153
Phase
PHASE2
Status
Terminated

Conditions

  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • Untreated Adult Acute Myeloid Leukemia

Eligibility Criteria

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

Interventions

  • gemtuzumab ozogamicin — DRUG
    Given IV
  • vorinostat — DRUG
    Given orally
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

RATIONALE: Vorinostat may stop the growth of cancer cells by interfering with various proteins needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin (GO), can block cancer growth in different ways. GO finds cancer cells and helps kill them by carrying a cancer-killing substance to them. Giving vorinostat together with gemtuzumab ozogamicin may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving vorinostat together with gemtuzumab ozogamicin works in treating older patients with previously untreated acute myeloid leukemia.

Key Dates

Start date
Mar 31, 2008
Status verified
May 2017
Primary completion
Aug 31, 2010

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to 3 courses. . CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin IV over 2 hours on day 8. MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment repeats every 28 days for 4 courses.

Primary Outcome Measure

Number of Participants Achieving CR or CRi With Induction Therapy (Good-risk Group) [ Time Frame: after completion of induction therapy, administered every 21-42 days for up to two courses ]

Locations (4)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157-
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Stanford, CA

By research site
Stanford University· Stanford, CABarbara Ann Karmanos Cancer Institute· Detroit, MIWake Forest University Health Sciences· Winston-Salem, NCFred Hutchinson Cancer Research Center/University of Washington Cancer Consortium· Seattle, WA

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