CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme
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ClinicalTrials.gov Identifier: NCT00016328 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | May 6, 2001 | |||
First Posted Date ICMJE | January 27, 2003 | |||
Last Update Posted Date | July 18, 2013 | |||
Study Start Date ICMJE | May 2001 | |||
Actual Primary Completion Date | August 2005 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme | |||
Official Title ICMJE | A Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme | |||
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. | |||
Detailed Description | 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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | 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:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
33 | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | August 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | Canada | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00016328 | |||
Other Study ID Numbers ICMJE | NCI-2012-01858 N997B CDR0000068623 NCCTG-N997B U10CA025224 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | National Cancer Institute (NCI) | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | National Cancer Institute (NCI) | |||
Original Study Sponsor ICMJE | North Central Cancer Treatment Group | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | |||
Verification Date | June 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |