|
Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma Clinical research trials and Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma. Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma clinical trial. Subjects frequently get the best healthcare possible for their Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma  Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
For Condition: adult anaplastic astrocytoma,adult glioblastoma multiforme,Mixed Gliomas,recurrent adult brain tumor,adult anaplastic oligodendroglioma,adult malignant meningioma
Status: Recruiting
Sponsor(s): North American Brain Tumor Consortium , National Cancer Institute (NCI)
Synopsis: RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase I/II trial to study the effectiveness of erlotinib in treating patients who have recurrentmalignantglioma or recurrent or progressivemeningioma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of erlotinib in patients with recurrent malignant glioma or recurrent or progressive meningioma. - Determine the safety profile of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine the 6-month progression-free survival, 12-month survival, and objective tumor response of patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to study phase (I vs II), concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no), histology (recurrent GBM vs recurrent anaplastic glioma vs recurrent meningioma vs stable GBM), preoperative candidacy (yes vs no), and concurrent steroids (yes vs no). - Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Once the MTD is determined, additional patients concurrently receiving EIAEDs are treated with erlotinib as above at the phase II dose. Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose. Patients are followed for survival. PROJECTED ACCRUAL: Approximately 36 patients will be accrued for the phase I portion of this study within 1 year. Approximately 117-122 patients (32 recurrent glioblastoma multiforme [GBM], 20 recurrent anaplastic gliomas, 55 stable post-radiotherapy GBM, and 10-15 recurrent meningioma) will be accrued for the phase II portion of this study within 15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following diagnoses: - Histologically confirmed intracranial malignant glioma - Glioblastoma multiforme (GBM), anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified - Original histology of low-grade glioma allowed provided a subsequent histology of malignant glioma is confirmed - Histologically or radiographically confirmed recurrent or progressive benign or malignant meningioma - Progressive disease or tumor recurrence on MRI or CT scan - Phase I: No more than 3 prior relapses and no more than 2 prior chemotherapy* or biologic therapy regimens - Phase II: No more than 2 prior relapses and no more than 2 prior chemotherapy* or biologic therapy regimens NOTE: *Including polifeprosan 20 with carmustine implants (Gliadel wafers) - Patients with progressive disease must have failed prior radiotherapy* that was completed at least 4 weeks ago - Patients with progressive disease between 4 and 12 weeks after completion of external beam radiotherapy must have clear evidence of progression on MRI - Patients with GBM who have completed external beam radiotherapy and do not show progression are eligible - Patients with progressive disease after interstitial brachytherapy or stereotactic radiosurgery must have confirmed true progression rather than radiation necrosis based upon positron-emission tomography, thallium scanning, MRI, or surgical documentation NOTE: *Prior radiotherapy is not required for patients with meningioma - Measurable or evaluable disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - More than 8 weeks Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 mg/dL (transfusion allowed) Hepatic - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGOT less than 1.5 times ULN Renal - Creatinine less than 1.5 mg/dL Ophthalmic - None of the following ophthalmic abnormalities: - Abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) - Congenital abnormality (e.g., Fuch's dystrophy) - Abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) - Abnormal corneal sensitivity test (Schirmer test or similar tear production test) - Patients found to have dry eyes on examination but have an otherwise normal examination allowed Other - No active infection - No other serious concurrent medical illness - No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No other disease that would obscure toxicity or dangerously alter drug metabolism - No significant medical illness that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception during and for 12 weeks after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - At least 1 week since prior thalidomide - At least 1 week since prior interferon - At least 4 weeks since prior SU5416 or other experimental biologic agents Chemotherapy - See Disease Characteristics - No prior chemotherapy (including polifeprosan 20 with carmustine implant [Gliadel wafers]) for patients with stable GBM - At least 2 weeks since prior vincristine - At least 3 weeks since prior procarbazine - At least 6 weeks since prior nitrosoureas Endocrine therapy - At least 1 week since prior tamoxifen Radiotherapy - See Disease Characteristics - Recovered from prior radiotherapy - No more than 6 weeks since prior external beam radiotherapy for patients with GBM without evidence of progression Surgery - Recovered from prior surgery Other - Recovered from prior therapy - At least 1 week since prior noncytotoxic agents (e.g., isotretinoin) except radiosensitizers - At least 4 weeks since prior cytotoxic therapy - At least 4 weeks since prior tipifarnib or imatinib mesylate - No prior erlotinib or other epidermal growth factor receptor inhibitors - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LaurenAbrey, Study Chair, Memorial Sloan-Kettering Cancer Center
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Patrick Wen 617-632-2166
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Lauren Abrey 212-639-5122
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Wai-Kwan Yung 713-794-1285
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15232
United States
Recruiting Frank Lieberman 412-692-2600
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
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0316
United States
Recruiting Larry Junck 734-936-7910
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9154
United States
Recruiting Karen Fink 214-648-4730
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Michael Prados 415-353-9510
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Timothy Cloughesy 310-825-5321
Additional Information:
Study ID Numbers: CDR0000256358; NABTC-0103,NCI-03-C-0114
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045110
Other Adult Glioblastoma Multiforme Studies:
1. Karenitecin in Treating Patients With Recurrent Malignant Glioma
2. Chemotherapy in Treating Patients With Progressive or Recurrent Brain Tumors
3. Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
4. Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma
5. PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas
Related Studies:
Other adult glioblastoma multiforme Clinical Trials
Other California Clinical Trials
Other San Francisco Clinical Trials
Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
|
|
|
|
|
|
|
|
