CCI-779 in Treating Patients With Recurrent Glioblastoma Multiforme

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00016328
First received: May 6, 2001
Last updated: July 17, 2013
Last verified: June 2013
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of CCI-779 in Patients With Recurrent Glioblastoma Multiforme

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Percentage of patients being progression free [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Ninety-five percent confidence intervals for the true proportion will be calculated according to the approach of Duffy and Santner.


Secondary Outcome Measures:
  • Percentage of patients that have not progressed [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Estimated using Kaplan-Meier. Frequency distributions of baseline patient characteristics will be compared using chi-squared and Wilcoxon tests.


Enrollment: 33
Study Start Date: May 2001
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016328

Locations
United States, Minnesota
North Central Cancer Treatment Group
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Investigators
Principal Investigator: Evanthia Galanis North Central Cancer Treatment Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00016328     History of Changes
Other Study ID Numbers: NCI-2012-01858, N997B, CDR0000068623, NCCTG-N997B, U10CA025224
Study First Received: May 6, 2001
Last Updated: July 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brain Neoplasms
Glioblastoma
Gliosarcoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014