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PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas Clinical research trials and PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas. PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas clinical trial. Subjects frequently obtain the most expert healthcare possible for their PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas  PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas
PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas
For Condition: adult anaplastic oligodendroglioma,Mixed Gliomas,adult anaplastic astrocytoma,recurrent adult brain tumor,adult brain stem glioma,adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Biological therapies such as PEG-interferon alfa-2b use different ways to stimulate the immune system and stop cancer cells from growing. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if PEG-interferon alfa-2b is more effective with or without thalidomide in treating recurrenthigh-gradegliomas. PURPOSE: Randomizedphase II trial to study the effectiveness of PEG-interferon alfa-2b with or without thalidomide in treating patients who have recurrent high-grade gliomas.
Details: OBJECTIVES: - Determine the antitumor efficacy, in terms of progression-free survival, of PEG-interferon alfa-2b with or without thalidomide in patients with recurrent high grade gliomas. - Determine the toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type of glioma (glioblastoma multiforme vs anaplastic glioma). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive PEG-interferon alfa-2b subcutaneously once weekly. - Arm II: Patients receive PEG-interferon alfa-2b as in arm I and oral thalidomide once daily on day 1 and 3-42. Courses in both arms repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 96 patients (48 per treatment arm) will be accrued for this study within 12-16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed supratentorial malignant primary gliomas including the following: - Glioblastoma multiforme - Anaplastic astrocytoma - Anaplastic oligodendroglioma - Anaplastic mixed oligoastrocytoma - Malignant astrocytoma not otherwise specified - Recurrent disease - Failed prior radiotherapy - Prior therapy for no more than 2 relapses - Measurable or evaluable disease with evidence of tumor recurrence or progression by MRI or CT scan - Scan performed within 14 days prior to study and on a stable steroid dose for at least 5-7 days - Patients who have undergone prior resection of recurrent or progressive tumor require evaluable disease only - Progressive disease must be confirmed (vs radiation necrosis) by positron emission tomography, thallium scan, MR spectroscopy, or surgery if received 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/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - SGOT less than 2 times upper limit of normal (ULN) - Bilirubin less than 2 times ULN Renal - Creatinine less than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception for 1 month prior, during, and for 4 months after treatment with thalidomide - No disease that would obscure toxicity or dangerously alter drug metabolism - No peripheral neuropathy greater than grade 1 - No other cancer within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No serious active infection - No other serious concurrent medical illness - No concurrent significant illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No prior PEG-interferon alfa-2B - No concurrent immunotherapy Chemotherapy - At least 4 weeks since prior cytotoxic therapy - At least 2 weeks since prior vincristine - At least 6 weeks since prior nitrosoureas - At least 3 weeks since prior procarbazine - Prior radiosensitizer allowed - No concurrent chemotherapy Endocrine therapy - At least 1 week since prior tamoxifen Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - See Disease Characteristics - Recovered from prior surgery Other - Recovered from prior therapy - At least 1 week since prior non-cytotoxic agent except radiosensitizer - At least 1 week since prior isotretinoin - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardFine, Study Chair, Neuro-Oncology Branch
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Timothy Cloughesy 310-825-5321
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Patrick Wen 617-632-2166
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting Minesh Mehta 608-263-8500
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, 48109-0316
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
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
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Lisa DeAngelis 212-639-7123
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Michael Prados 415-353-9510
Additional Information:
Study ID Numbers: CDR0000258609; NCI-03-C-0002,NABTC-0201
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052650
Other Adult Brain Stem Glioma Studies:
1. Antineoplaston Therapy in Treating Patients With Anaplastic Astrocytoma
2. Suramin in Treating Patients With Recurrent Primary Brain Tumors
3. O(6)-benzylguanine in Treating Patients With Malignant Glioma
4. Radiation Therapy Combined With Chemotherapy in Treating Patients With Anaplastic Astrocytoma or Mixed Gliomas
5. Radiolabeled Monoclonal Antibody in Treating Patients With Glioblastoma Multiforme or Anaplastic Astrocytoma
Related Studies:
Other adult brain stem glioma Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
PEG-Interferon alfa-2b With or Without Thalidomide in Treating Patients With Recurrent High-Grade Gliomas
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