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CCI-779 in Treating Patients With Malignant Glioma

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00022724
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Susan M. Chang, MD
Principal Investigator Affiliation University of California, San Francisco
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors
Additional Details

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.#46;no) and disease type (glioblastoma multiforme with stable neuro-imaging after radiotherapy vs.#46;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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles, California

Status

Address

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095

UCSF Comprehensive Cancer Center, San Francisco, California

Status

Address

UCSF Comprehensive Cancer Center

San Francisco, California, 94143

Bethesda, Maryland

Status

Address

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182

Boston, Massachusetts

Status

Address

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115

Ann Arbor, Michigan

Status

Address

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942

Memorial Sloan-Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021

Pittsburgh, Pennsylvania

Status

Address

Hillman Cancer Center at University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232

Houston, Texas

Status

Address

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009

San Antonio, Texas

Status

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-6220

Madison, Wisconsin

Status

Address

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792