NCT00086840

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

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

Study Start

First participant enrolled

May 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

1.3 years

First QC Date

July 8, 2004

Last Update Submit

January 23, 2013

Conditions

Recurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Hodgkin LymphomaRefractory Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Response (CR or PR)

    Defined as the complete disappearance of all known disease, or a 50% decrease in tumor size using the sum of the product (bi-perpendicular dimensions when available).

    6 months

Study Arms (1)

Treatment (temsirolimus)

EXPERIMENTAL

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response may receive 3 consolidation courses of therapy.

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 chronic lymphocytic leukemia (CLL)
  • Relapsed, refractory, or transformed disease
  • Relapsed disease defined as symptomatic loss of a prior partial or complete response to a regimen containing a purine analog and/or a monoclonal antibody AND evidence of disease progression
  • Primary resistant disease defined as failure to achieve an objective response to a regimen containing a purine analog and/or a monoclonal antibody
  • Transformed CLL (Richters transformation), must meet both of the following criteria:
  • Histologically confirmed lymphoma
  • Measurable disease
  • No CNS disease
  • Performance status - ECOG 0-2
  • Bilirubin ≤ 2 mg/dL (unless elevated due to Gilbert's disease)
  • SGOT and SGPT \< 3 times upper limit of normal
  • Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement)
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • +16 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

Lymphoma, Large B-Cell, DiffuseHodgkin DiseaseLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

temsirolimusSirolimus

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

July 8, 2004

First Posted

July 12, 2004

Study Start

May 1, 2004

Primary Completion

August 1, 2005

Last Updated

January 24, 2013

Record last verified: 2013-01

Locations

US(1)