NCT00278330

Brief Summary

This phase I trial is studying the side effects and best dose of flavopiridol when given together with vorinostat in treating patients with relapsed or refractory acute leukemia or chronic myelogenous leukemia or refractory anemia. Flavopiridol and vorinostat may cause leukemia cells to look more like normal cells, and to grow and spread more slowly. Vorinostat may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving flavopiridol together with vorinostat may be an effective treatment for leukemia or refractory anemia.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 18, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Last Updated

April 2, 2013

Status Verified

April 1, 2013

Enrollment Period

3.8 years

First QC Date

January 16, 2006

Last Update Submit

April 1, 2013

Conditions

Blastic Phase Chronic Myelogenous LeukemiaRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRefractory Anemia With Excess BlastsRelapsing Chronic Myelogenous LeukemiaUntreated Adult Acute Lymphoblastic LeukemiaUntreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • MTD for the combination of alvocidib and vorinostat, assessed by Common Toxicity Criteria version 3.0

    21 days

Study Arms (1)

Arm I

EXPERIMENTAL

Patients will receive a 1-hour infusion of flavopiridol on 5 days in week 1 and vorinostat by mouth three times a day in weeks 1 and 2. Treatment may repeat every 3 weeks for as long as benefit is shown.

Drug: alvocidibDrug: vorinostat

Interventions

alvocidibDRUG

Given by infusion

Also known as: FLAVO, flavopiridol, HMR 1275, L-868275
Arm I
vorinostatDRUG

Given orally

Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Arm I

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of one of the following:
  • Relapsed or refractory acute leukemia (acute myeloid leukemia \[AML\], acute lymphoblastic leukemia \[ALL\], or acute leukemia unclassifiable) following at least one prior systemic treatment
  • Acute leukemia in a patient 60 years or older (no requirement for prior treatment)
  • Acute leukemia that has evolved from a prior myelodysplastic syndrome
  • Chronic myelogenous leukemia (CML) in blast crisis following prior imatinib mesylate therapy
  • Refractory anemia with excess blasts-2 (RAEB-2)
  • No known CNS leukemia
  • ECOG performance status 0-2
  • WBC \< 50,000µL
  • Hydroxyurea and/or leukaphereses may be used to lower WBC
  • Creatinine =\< 1.5 times upper limit of normal (ULN) OR creatinine clearance \>= 50 mL/min
  • Total bilirubin =\< 2 times ULN
  • AST/ALT =\< 2.5 times ULN
  • QTc interval =\< 0.470 seconds
  • Not pregnant or nursing
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Blast CrisisPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteAnemia, Refractory, with Excess of Blasts

Interventions

alvocidibVorinostat

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAnemia, RefractoryAnemiaMyelodysplastic Syndromes

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesHydroxamic AcidsHydroxylaminesHydroxy AcidsCarboxylic Acids

Study Officials

  • Steven Grant

    Massey Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2006

First Posted

January 18, 2006

Study Start

January 1, 2006

Primary Completion

October 1, 2009

Last Updated

April 2, 2013

Record last verified: 2013-04

Locations

US(1)