NCT00101088

Brief Summary

This phase I trial is studying the side effects and best dose of temsirolimus when given with imatinib mesylate in treating patients with chronic myelogenous leukemia. Drugs used in chemotherapy, such as temsirolimus, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving temsirolimus with imatinib mesylate may kill more cancer cells

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

January 7, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 10, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Last Updated

January 14, 2013

Status Verified

January 1, 2013

Enrollment Period

5.2 years

First QC Date

January 7, 2005

Last Update Submit

January 11, 2013

Conditions

Accelerated Phase Chronic Myelogenous LeukemiaBlastic Phase Chronic Myelogenous LeukemiaChronic Myelogenous Leukemia, BCR-ABL1 PositiveChronic Phase Chronic Myelogenous LeukemiaRelapsing Chronic Myelogenous Leukemia

Outcome Measures

Primary Outcomes (1)

  • Unacceptable toxicity graded according to the NCI CTCAE version 3.0

    Up to 5 years

Secondary Outcomes (3)

  • Disease progression

    Up to 5 years

  • Duration of response

    Up to 5 years

  • Survival

    Up to 5 years

Study Arms (1)

Treatment (imatinib mesylate, temsirolimus)

EXPERIMENTAL

Patients receive temsirolimus IV over 30 minutes once on days 1, 8, 15, and 22 and oral imatinib mesylate once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression

Drug: imatinib mesylateDrug: temsirolimusOther: laboratory biomarker analysis

Interventions

imatinib mesylateDRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec
Treatment (imatinib mesylate, temsirolimus)
temsirolimusDRUG

Given IV

Also known as: CCI-779, cell cycle inhibitor 779, Torisel
Treatment (imatinib mesylate, temsirolimus)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (imatinib mesylate, temsirolimus)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed chronic myelogenous leukemia (CML)
  • Philadelphia chromosome-positive OR Bcr-Abl-positive disease, meeting 1 of the following criteria:
  • Accelerated phase, defined by at least 1 of the following:
  • % blasts in the peripheral blood or bone marrow
  • At least 20% basophils in peripheral blood or bone marrow
  • Platelet count \< 100,000/mm\^3 (unrelated to therapy)
  • Platelet count \> 1,000,000/mm\^3 (unresponsive to therapy)
  • Increasing splenomegaly AND increasing WBC count (unresponsive to therapy)
  • Clonal evolution
  • Blast phase, defined by 1 of the following:
  • At least 20% blasts in peripheral blood or bone marrow
  • Extramedullary disease
  • Chronic phase, defined by all of the following:
  • Less than 10% blasts in peripheral blood or bone marrow
  • Less than 20% basophils in peripheral blood or bone marrow
  • +60 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Medical Center At Irvine-Orange Campus

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Chronic-Phase

Interventions

Imatinib MesylatetemsirolimusSirolimus

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic Processes

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Tiong Ong

    University of California Medical Center At Irvine-Orange Campus

    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 7, 2005

First Posted

January 10, 2005

Study Start

April 1, 2005

Primary Completion

June 1, 2010

Last Updated

January 14, 2013

Record last verified: 2013-01

Locations

US(1)