CCI-779 in Treating Patients With Malignant Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00022724
First received: August 10, 2001
Last updated: November 22, 2008
Last verified: January 2005
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I/II trial to study the effectiveness of CCI-779 in treating patients who have malignant glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: temsirolimus
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I/II Trial Of CCI-779 In Patients With Malignant Glioma

Resource links provided by NLM:


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

Study Start Date: December 2001
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of CCI-779 in patients with malignant glioma.
  • Determine the safety profile of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the efficacy of this drug, in terms of survival and objective response, in these patients.

OUTLINE: This is a dose-escalation study. Patients in phase II are stratified according to use of enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no) and disease type (glioblastoma multiforme with stable neuro-imaging after radiotherapy vs recurrent malignant glioma). Patients in phase I must be currently receiving EIAEDs.

  • Phase I: Patients receive CCI-779 IV over 30 minutes once weekly. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of CCI-779 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive CCI-779 as in Phase I. Patients who are candidates for surgical resection of recurrent disease receive CCI-779 IV over 30 minutes 2 hours prior to surgery and then once weekly, as above, once recovered from surgery.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for phase I of this study within 12 months. A total of 87 patients will be accrued for phase II of this study within 12 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed intracranial malignant glioma

    • Glioblastoma multiforme
    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma
    • Anaplastic mixed oligoastrocytoma
    • Malignant astrocytoma not otherwise specified
  • Initial diagnosis of low-grade allowed, if subsequently progressed
  • Recurrent disease must have documented progression by MRI or CT scan
  • Progressive disease must have failed prior radiotherapy
  • Recent resection of recurrent or progressive tumor allowed provided all of the following are met:

    • Recovered from surgery
    • CT scan or MRI performed no more than 96 hours postoperatively OR at 4-6 weeks postoperatively
    • Concurrent steroid dosage must be stable
  • Confirmation of true progressive disease (by PET, thallium scan, MR spectroscopy, or surgical documentation) required after prior interstitial brachytherapy or stereotactic radiosurgery

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 8 weeks

Hematopoietic:

  • WBC at least 3,000/mm3
  • Absolute neutrophil count at least 2,000/mm3
  • Platelet count at least 120,000/mm3
  • Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT less than 1.5 times ULN
  • Cholesterol less than 350 mg/dL
  • Triglycerides less than 400 mg/dL

Renal:

  • Creatinine less than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min

Other:

  • No active infection
  • No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No significant medical illness that would preclude study
  • No disease that would obscure toxicity or dangerously alter drug metabolism
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779 or allergy to or inability to receive antihistamines
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 weeks after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 1 week since prior interferon

Chemotherapy:

  • At least 2 weeks since prior vincristine
  • At least 3 weeks since prior procarbazine
  • At least 6 weeks since prior nitrosoureas
  • Phase I:

    • 2 prior chemotherapy regimens allowed
    • 1 prior adjuvant regimen and 1 prior regimen for recurrent or progressive disease OR
    • 2 prior regimens for progressive tumor
  • Phase II:

    • No more than 1 prior chemotherapy regimen for recurrent malignant glioma
    • No prior chemotherapy allowed for stable glioblastoma multiforme

Endocrine therapy:

  • See Disease Characteristics
  • At least 1 week since prior tamoxifen

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy for progressive disease
  • No more than 1 month since prior radiotherapy for nonprogressive glioblastoma multiforme

Surgery:

  • See Disease Characteristics

Other:

  • Recovered from prior therapy
  • At least 1 week since prior noncytotoxic 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: NCT00022724

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94143
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-6220
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
North American Brain Tumor Consortium
Investigators
Study Chair: Susan M. Chang, MD University of California, San Francisco
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00022724     History of Changes
Other Study ID Numbers: CDR0000068848, NABTC-0101
Study First Received: August 10, 2001
Last Updated: November 22, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014