NCT00305773

Brief Summary

Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for their growth. Giving the drug in different ways may kill more cancer cells. This randomized phase II trial is studying two different schedules of vorinostat to see how well they work in treating patients with acute myeloid leukemia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 22, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

May 16, 2013

Completed
Last Updated

May 19, 2014

Status Verified

December 1, 2012

Enrollment Period

3.3 years

First QC Date

March 21, 2006

Results QC Date

March 28, 2013

Last Update Submit

April 30, 2014

Conditions

Adult Acute Erythroid Leukemia (M6)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) AbnormalitiesAdult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)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 Acute Promyelocytic Leukemia (M3)Recurrent Adult Acute Myeloid LeukemiaRefractory Cytopenia With Multilineage DysplasiaSecondary Acute Myeloid LeukemiaUntreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Confirmed Complete Response (CR) Rate

    The confirmed complete response rate was estimated by the number of participants with CR divided by the total number of evaluable participants. According to the International Working Group (IWG) Criteria for response in AML, to be considered a CR, the following must be met for at least 4 weeks: ANC \> 1500/mL, platelets \> 100000/mL, no circulating blasts, bone marrow cellularity \>20% (biopsy), trilineage maturation, \< 5% bone marrow blasts, no auer rods and no extramedullary disease.

    Up to 2 years

Secondary Outcomes (3)

  • Time to Progression (TTP)

    Duration of study (up to 2 years)

  • Overall Survival (OS)

    Duration of study (up to 2 years)

  • Number of Participants With Severe (Grade 3, 4 or 5) Adverse Events

    Duration of study (up to 2 years)

Other Outcomes (1)

  • Time to Treatment Failure (TTF)

    Duration of treatment (up to 17 cycles)

Study Arms (2)

Arm I (once daily vorinostat)

EXPERIMENTAL

Patients receive oral vorinostat (SAHA) once a day on days 1-21. In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

Drug: vorinostat

Arm II (thrice daily vorinostat)

EXPERIMENTAL

Patients receive oral SAHA three times a day on days 1-14. In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

Drug: vorinostat

Interventions

vorinostatDRUG

Given orally once daily

Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Arm I (once daily vorinostat)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of acute myeloid leukemia (AML), meeting 1 of the following criteria:
  • Relapsed AML in the following categories:
  • Good-risk cytogenetics \[inv(16), t (8;21)\] in second relapse or in first relapse following a remission of \< 12 months
  • Acute promyelocytic leukemia (M3) in second relapse or greater AND must have relapsed following both tretinoin-anthracycline-based therapy and arsenic trioxide-based therapy
  • All other relapsed patients are eligible
  • Untreated AML in the following categories:
  • At least 65 years of age
  • Myelodysplastic syndromes-AML (AML with trilineage dysplasia)
  • AML with del5Q or monosomy 5, monosomy 7, or complex cytogenetics (≥ 3 cytogenetic abnormalities)
  • Refused or ineligible for potentially curative options such as allogeneic stem cell transplantation
  • No clinical evidence of CNS or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia
  • ECOG performance status (PS) 0-2 or Karnofsky PS ≥ 60%
  • Life expectancy ≥ 3 months
  • Bilirubin normal unless attributed to hemolysis or Gilbert's disease in the opinion of the investigator
  • AST/ALT ≤ 2.5 times upper limit of normal (ULN)
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Schaefer EW, Loaiza-Bonilla A, Juckett M, DiPersio JF, Roy V, Slack J, Wu W, Laumann K, Espinoza-Delgado I, Gore SD; Mayo P2C Phase II Consortium. A phase 2 study of vorinostat in acute myeloid leukemia. Haematologica. 2009 Oct;94(10):1375-82. doi: 10.3324/haematol.2009.009217.

    PMID: 19794082DERIVED

MeSH Terms

Conditions

Leukemia, Erythroblastic, AcuteLeukemia, Megakaryoblastic, AcuteLeukemia, Monocytic, AcuteLeukemia, Myeloid, AcuteCongenital AbnormalitiesLeukemia, Myelomonocytic, AcuteLeukemia, Promyelocytic, Acute

Interventions

Vorinostat

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic Acids

Results Point of Contact

Title
Steven Gore, MD
Organization
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
gorest@jhmi.edu

Study Officials

  • Steven Gore

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2006

First Posted

March 22, 2006

Study Start

January 1, 2006

Primary Completion

May 1, 2009

Study Completion

January 1, 2010

Last Updated

May 19, 2014

Results First Posted

May 16, 2013

Record last verified: 2012-12

Locations

US(1)