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CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme

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.
 
ClinicalTrials.gov Identifier: NCT00016328
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2013
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
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
 (submitted: December 21, 2012)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2012)
  • 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.
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.

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
Condition  ICMJE
  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor
Intervention  ICMJE
  • 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
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:
  • Drug: temsirolimus
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2012)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Evanthia Galanis North Central Cancer Treatment Group
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