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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
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor Drug: temsirolimus Other: laboratory biomarker analysis Other: pharmacological study Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme
Study Start Date : May 2001
Actual Primary Completion Date : August 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016328


Locations
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United States, Minnesota
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Evanthia Galanis North Central Cancer Treatment Group
More Information
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00016328    
Other Study ID Numbers: NCI-2012-01858
N997B
CDR0000068623
NCCTG-N997B
U10CA025224 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Glioblastoma
Gliosarcoma
Recurrence
Disease Attributes
Pathologic Processes
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs