NCT00040105

Brief Summary

The goal of this clinical research study is to find the highest safe dose of the drugs ZarnestraTM (R115777) and Gleevec (imatinib mesylate) that can be given in combination for the treatment of chronic myelogenous leukemia (CML) in chronic phase. The effect of this combination on the leukemia will also be studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2002

Longer than P75 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

First Submitted

Initial submission to the registry

June 19, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2002

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2002

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

6.4 years

First QC Date

June 19, 2002

Last Update Submit

July 31, 2012

Conditions

Leukemia, Myeloid, Chronic

Keywords

Chronic Myelogenous Leukemia, Chronic PhaseR115777ZarnestraTipifarnibImatinib MesylateGleevecImatinibSTI571NSC-716051

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated doses (MTD)

    Every 3 months

Secondary Outcomes (1)

  • Toxicity of the ZARNESTRA and Gleevec combination

    July 2009

Study Arms (1)

Zarnestra + Gleevec

EXPERIMENTAL
Drug: Zarnestra (R115777)Drug: Gleevec (Imatinib mesylate)

Interventions

Zarnestra (R115777)DRUG

Starting Dose: 300 mg by mouth (PO) Twice daily

Also known as: Tipifarnib
Zarnestra + Gleevec
Gleevec (Imatinib mesylate)DRUG

Starting Dose: 300 mg By Mouth (PO) daily

Also known as: Imatinib, STI571, NSC-716051
Zarnestra + Gleevec

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 16 years or older with Philadelphia chromosome (Ph)- or BCR/ABL-positive CML (as determined by cytogenetics, FISH, or PCR) are eligible if they are not candidates for known regimens or protocol treatments of higher efficacy or priority. Patients must be in the chronic phase of CML.
  • Patients must have failed therapy with imatinib mesylate. Failure will be defined as: 1) patients who have failed to achieve or have lost a complete hematologic remission at 3 months from the start of therapy with imatinib mesylate, or 2) patients who have failed to achieve or have lost at least a minimal cytogenetic response after 6 months of therapy with imatinib mesylate, or 3) patients who have failed to achieve or have lost a major cytogenetic response after 12 months of therapy with imatinib mesylate
  • Chronic phase will be defined by the following features: 1) blasts in peripheral blood or bone marrow \<10%, 2) basophils in PB or BM \<20%, 3) platelets \>100 x 10(9)/L, 4) absence of clonal evolution
  • Patients must sign an informed consent
  • Performance status \</= 2 by Zubrod scale
  • Patients must have adequate hepatic functions (bilirubin \</= 2.0 mg/dl) and renal functions (creatinine \</=2 mg/dl)
  • WBC \</= 30 x 10(9)/L. Patients may receive Hydroxyurea (or other similar agent) to bring the WBC below this level. Hydroxyurea (or its equivalent) must be discontinued 24 hours before the start of therapy.
  • Patients of childbearing potential should practice effective methods of contraception.

You may not qualify if:

  • Patients under 16 years of age.
  • Pregnant and nursing females will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-Phase

Interventions

tipifarnibImatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Jorge E Cortes, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2002

First Posted

June 21, 2002

Study Start

October 1, 2002

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

US(1)