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Home > "C" Clinical Trials Conditions > CCI-779 in Treating Patients With Malignant Glioma  CCI-779 in Treating Patients With Malignant Glioma
CCI-779 in Treating Patients With Malignant Glioma
For Condition: adult anaplastic oligodendroglioma,adult anaplastic astrocytoma,Mixed Gliomas,recurrent adult brain tumor,adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): North American Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: 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 malignantglioma.
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 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. - 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. - 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanChang, Study Chair, University of California, San Francisco
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9154
United States
Recruiting Karen Fink 214-648-4730
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Patrick Wen 617-632-2166
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Michael Prados 415-353-2966
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Frank Lieberman 412-692-2600
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0942
United States
Recruiting Harry Greenberg 734-936-1831
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Lisa DeAngelis 212-639-7123
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 1-888-NCI-1937
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Timothy Cloughesy 310-825-5321
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Wai-Kwan Yung 713-794-1285
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78284-6220
United States
Recruiting John Kuhn 210-567-8355
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Minesh Mehta 608-263-8500
Additional Information:
Study ID Numbers: CDR0000068848; NABTC-0101
Study Start Date:
Record last reviewed: February 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022724
Other Mixed Gliomas Studies:
1. Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
2. O6-benzylguanine and Carmustine Implants in Treating Patients With Recurrent Malignant Glioma
3. Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma
4. Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
5. Suramin Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Related Studies:
Other Mixed Gliomas Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
CCI-779 in Treating Patients With Malignant Glioma
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