NCT00016328

Brief Summary

Phase II trial to study the effectiveness of CCI-779 in treating patients who have recurrent glioblastoma multiforme. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 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

May 1, 2001

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Last Updated

July 18, 2013

Status Verified

June 1, 2013

Enrollment Period

4.3 years

First QC Date

May 6, 2001

Last Update Submit

July 17, 2013

Conditions

Adult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaRecurrent Adult Brain Tumor

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients being progression free

    Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.

    6 months

Secondary Outcomes (5)

  • Percentage of patients that have not progressed

    3 months

  • Percentage of patients that have not progressed

    12 months

  • Percentage of patients that have not progressed

    18 months

  • Confirmed tumor response defined as an objective status of complete response (CR), partial response (PR), or regression (REGR) on two consecutive evaluations

    Up to 10 years

  • Time to progression and death

    Up to 10 years

Study Arms (1)

Treatment (temsirolimus)

EXPERIMENTAL

Patients receive CCI-779 IV over 30 minutes once weekly for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: temsirolimusOther: laboratory biomarker analysisOther: pharmacological study

Interventions

temsirolimusDRUG

Given IV

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

Correlative studies

Treatment (temsirolimus)
pharmacological studyOTHER

Correlative studies

Also known as: pharmacological studies
Treatment (temsirolimus)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed grade 4 astrocytoma at primary diagnosis or recurrence
  • Gliosarcoma allowed
  • Evidence of tumor progression by MRI or CT scan after radiotherapy or first-line chemotherapy
  • Measurable or evaluable disease by MRI or CT scan
  • Performance status - ECOG 0-2
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Hemoglobin at least 9 g/dL
  • Bilirubin no greater than 1.5 mg/dL
  • SGOT no greater than 3 times upper limit of normal
  • Creatinine no greater than 2.0 mg/dL
  • No myocardial infarction within the past 6 months
  • No congestive heart failure requiring ongoing maintenance therapy for life-threatening ventricular arrhythmias
  • Cholesterol no greater than 350 mg/dL
  • Triglycerides no greater than 400 mg/dL
  • +22 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Central Cancer Treatment Group

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

GlioblastomaGliosarcomaBrain Neoplasms

Interventions

temsirolimusSirolimus

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Evanthia Galanis

    North Central Cancer Treatment Group

    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

May 6, 2001

First Posted

January 27, 2003

Study Start

May 1, 2001

Primary Completion

August 1, 2005

Last Updated

July 18, 2013

Record last verified: 2013-06

Locations

US(1)