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CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00016328
First Posted: January 27, 2003
Last Update Posted: July 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
May 6, 2001
January 27, 2003
July 18, 2013
May 2001
August 2005   (Final data collection date for primary outcome measure)
Percentage of patients being progression free [ Time Frame: 6 months ]
Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.
Not Provided
Complete list of historical versions of study NCT00016328 on ClinicalTrials.gov Archive Site
  • Percentage of patients that have not progressed [ Time Frame: 3 months ]
    Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.
  • Percentage of patients that have not progressed [ Time Frame: 12 months ]
    Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.
  • Percentage of patients that have not progressed [ Time Frame: 18 months ]
    Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.
  • Confirmed tumor response defined as an objective status of complete response (CR), partial response (PR), or regression (REGR) on two consecutive evaluations [ Time Frame: Up to 10 years ]
    Ninety-five percent confidence intervals for the true proportion will be calculated using the exact binomial method.
  • Time to progression and death [ Time Frame: Up to 10 years ]
    Estimated using Kaplan-Meier. Frequency distributions of baseline patient characteristics will be compared using chi-squared and Wilcoxon tests.
Not Provided
Not Provided
Not Provided
 
CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme
A Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme
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.

OBJECTIVES:

I. Determine the efficacy of CCI-779, in terms of the percentage of patients who are progression-free at 6 months, time to progression, and time to death, in patients with recurrent glioblastoma multiforme.

II. Determine the toxic effects of this drug in these patients. III. Correlate molecular alterations in the tumors of these patients with response to treatment with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to concurrent P450 anticonvulsant use (yes vs no).

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.

Patients are followed every 6 months for 5 years and then annually for up to 10 years.

PROJECTED ACCRUAL: A total of 63 patients will be accrued for this study within 39 months.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor
  • Drug: temsirolimus
    Given IV
    Other Names:
    • CCI-779
    • cell cycle inhibitor 779
    • Torisel
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: pharmacological study
    Correlative studies
    Other Name: pharmacological studies
Experimental: Treatment (temsirolimus)
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.
Interventions:
  • Drug: temsirolimus
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
Not Provided
August 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • Willing to provide correlative laboratory samples
  • No uncontrolled infection
  • No known hypersensitivity to any components of CCI-779, diphenhydramine hydrochloride, or other similar antihistamines
  • No other medical reason that would preclude diphenhydramine premedication
  • No other active malignancy
  • No other severe disease that would preclude study participation
  • Not immunocompromised unless due to corticosteroids
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • See Disease Characteristics
  • Prior adjuvant chemotherapy allowed
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No more than 1 prior chemotherapy regimen for recurrent/progressive disease
  • No prior polifeprosan 20 with carmustine implant (Gliadel)
  • Must be on fixed dose of corticosteroids (or no corticosteroids) at least 1 week prior to baseline scan
  • See Disease Characteristics
  • At least 12 weeks since prior radiotherapy
  • No prior stereotactic radiosurgery or interstitial brachytherapy unless there is a separate lesion on MRI that is outside of the previously treated field
  • No prior resection since last chemotherapy or radiotherapy unless there is unequivocal tumor growth on neuro-imaging study since surgery or there is a separate lesion not present in the surgical bed
  • More than 4 weeks since prior investigational agents
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
Canada
 
NCT00016328
NCI-2012-01858
N997B
CDR0000068623
NCCTG-N997B
U10CA025224 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Evanthia Galanis North Central Cancer Treatment Group
National Cancer Institute (NCI)
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP