Vorinostat, Azacitidine, and Gemtuzumab Ozogamicin for Older Patients With Relapsed or Refractory AML

Part of paid clinical trials in Stanford, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00895934
Phase
PHASE1/PHASE2
Status
Completed

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 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)
  • Recurrent Adult Acute Myeloid Leukemia

Eligibility Criteria

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

Interventions

  • vorinostat — DRUG
    Given orally
  • gemtuzumab ozogamicin — DRUG
    Given intravenously (IV)
  • azacitidine — DRUG
    Given IV or subcutaneously (SC)

Study Details

The purpose of this study is to test the safety of vorinostat (Zolinza) and azacitidine (Vidaza) when combined with gemtuzumab ozogamicin (GO) at different dose levels. These drugs increase the effect of GO against leukemia cells in the test tube, but we don't know yet whether they also increase the anti-leukemia effect of GO in people.

Key Dates

Start date
May 31, 2009
Status verified
May 2019
Primary completion
Jul 31, 2013
Completion
Sep 30, 2013

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 - Dose Finding
    Varying schedules and dose levels of vorinostat, azacitidine and gemtuzumab ozogamicin. Includes cohorts 1-3.
  • Experimental: Phase 2 - Treatment at Selected Dose
    Vorinostat 400 mg/day on days 1-9, azacitidine 75 mg/m2/day on days 1-7, gemtuzumab ozogamicin 3 mg/m2/day on days 4 and 8.

Primary Outcome Measure

Number of Participants With Dose-limiting Toxicity (Phase I) [ Time Frame: 42 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Stanford University Hospitals and ClinicsStanfordCalifornia94305-
Harrison HealthPartners Hematology and Oncology-BremertonBremertonWashington98310-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-
University of Washington Medical CenterSeattleWashington98195-

Find similar trials in Stanford, CA

By research site
Stanford University Hospitals and Clinics· Stanford, CAHarrison HealthPartners Hematology and Oncology-Bremerton· Bremerton, WAFred Hutchinson Cancer Research Center· Seattle, WAUniversity of Washington Medical Center· Seattle, WA

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