NCT00084916

Brief Summary

Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia in blastic phase

Trial Health

80
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 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

April 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2004

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Last Updated

January 23, 2013

Status Verified

January 1, 2013

Enrollment Period

2.9 years

First QC Date

June 10, 2004

Last Update Submit

January 22, 2013

Conditions

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)Blastic Phase Chronic Myelogenous LeukemiaChronic Myelomonocytic Leukemiade Novo Myelodysplastic SyndromesPreviously Treated Myelodysplastic SyndromesRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRefractory Anemia With Excess BlastsRefractory Anemia With Excess Blasts in TransformationRelapsing Chronic Myelogenous LeukemiaSecondary Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

  • Response rate of 20%

    The 95% confidence intervals should be provided.

    Up to 3 years

Study Arms (1)

Treatment (temsirolimus)

EXPERIMENTAL

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: temsirolimusOther: laboratory biomarker analysis

Interventions

temsirolimusDRUG

Given IV

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

Correlative studies

Treatment (temsirolimus)

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of 1 of the following:
  • Acute myeloid leukemia
  • Acute lymphoblastic leukemia
  • Myelodysplastic syndromes
  • Refractory anemia with excess blasts \[RAEB\]
  • RAEB in transformation
  • Chronic myelomonocytic leukemia in transformation with ≥ 10% peripheral blood/bone marrow blasts
  • Chronic myelogenous leukemia in blastic phase
  • Disease status must meet 1 of the following criteria:
  • Primary resistant disease (i.e., failed to achieve a complete response \[CR\] to a prior standard induction regimen)
  • Relapsed disease after achieving a CR
  • Documented failure to most recent cytotoxic regimen
  • No other potentially curative options
  • No known CNS disease
  • Performance status - ECOG 0-2
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Congenital AbnormalitiesBlast CrisisLeukemia, Myelomonocytic, ChronicPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteAnemia, Refractory, with Excess of Blasts

Interventions

temsirolimusSirolimus

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, 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 SymptomsMyelodysplastic-Myeloproliferative DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAnemia, RefractoryAnemiaMyelodysplastic Syndromes

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Francis Giles

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2004

First Posted

June 11, 2004

Study Start

April 1, 2004

Primary Completion

March 1, 2007

Last Updated

January 23, 2013

Record last verified: 2013-01

Locations

US(1)