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Phase II Trial of Peginterferon alpha-2b and Thalidomide in Adults with Recurrent Gliomas Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Phase II Trial of Peginterferon alpha-2b and Thalidomide in Adults with Recurrent Gliomas conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase II Trial of Peginterferon alpha-2b and Thalidomide in Adults with Recurrent Gliomas Clinical research trials and Phase II Trial of Peginterferon alpha-2b and Thalidomide in Adults with Recurrent Gliomas health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Phase II Trial of Peginterferon alpha-2b and Thalidomide in Adults with Recurrent Gliomas. Phase II Trial of Peginterferon alpha-2b and Thalidomide in Adults with Recurrent Gliomas Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Phase II Trial of Peginterferon alpha-2b and Thalidomide in Adults with Recurrent Gliomas clinical trial. Test subjects typically receive the most expert healthcare available for their Phase II Trial of Peginterferon alpha-2b and Thalidomide in Adults with Recurrent Gliomas condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase II Trial of Peginterferon alpha-2b and Thalidomide in Adults with Recurrent Gliomas  Phase II Trial of Peginterferon alpha-2b and Thalidomide in Adults with Recurrent Gliomas
Phase II Trial of Peginterferon alpha-2b and Thalidomide in Adults with Recurrent Gliomas
For Condition: Glioma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine the safety and effectiveness of peginterferon alpha-2b (PEG-Intron) alone and together with thalidomide in patients with gliomas (a type of brain tumor). Gliomas are nourished by blood delivered through blood vessels whose formation is stimulated by substances produced by the tumor itself. Stopping the growth of new vessels can slow or prevent tumor growth. The Food and Drug Administration has approved various interferons for treating several diseases, including melanoma and some leukemias. These drugs block new vessel growth in patients with recurrent tumors, but in high doses they produce serious side effects. Therefore, this study will use a low dose of PEG-Intron given weekly instead of high doses given several times a week. Thalidomide, currently approved to treat leprosy, also blocks development of new blood vessel formation. In a recent study of thalidomide given to 36 patients with gliomas, 4 patients had tumor shrinkage, 12 had stable disease for at least 2 months, and at least 3 had responses to treatment lasting 6 to 14 months. Patients 18 years of age and older with a primary glioma whose tumor has recurred or is growing following standard treatment and does not respond to radiation therapy may be eligible for this study. Candidates will be screened with a physical examination, blood and urine tests (including a pregnancy test for women of childbearing potential), and magnetic resonance imaging (MRI) or computed tomograpy (CT) of the head. Participants will be randomly assigned to take PEG-Intron alone or PEG-Intron plus thalidomide. Both groups will receive PEG-Intron injections under the skin once a week for each 6-week treatment cycle. Patients in the thalidomide group will also take thalidomide daily by mouth for each 6-week cycle. Patients will continue treatment cycles as long as the drug is tolerated without serious side effects and the tumor is not growing. While on the study, patients will undergo various tests and procedures as follows: -Physical and neurologic examinations every 6 weeks -MRI or CT brain scan every 6 weeks to assess tumor status. MRI is a diagnostic test that uses a strong magnetic field and radio waves to show structural and chemical changes in tissues. During the scan, the patient lies on a table in a narrow cylinder containing a magnetic field. He or she can speak with a staff member through an intercom system at all times during the procedure. CT produces images of the brain in small sections. It can be done from different angles to show a three dimensional picture. -Routine blood tests every 3 weeks and an additional blood test every 6 weeks -Urine sample every 6 weeks -Pregnancy test for women of childbearing potential every week for the first 4 weeks and then every 2 or 4 weeks, depending on menstrual regularity Patients may also be asked to undergo magnetic resonance with spectroscopy (MRS) or PET scanning to help distinguish living tumors from dying tumors. The experience of having MRS is identical to that of the standard MRI and will be done at the same time as the MRI. PET shows cellular activity in the brain. For this test, a sugar solution with a radioactive particle attached is injected through a vein. The radioactive substance allows the fluid to be seen with a special gamma camera. The sugar is fuel for cells and is taken up by the most active cells. Since cancer cells are very active, tracing the sugar uptake allows detection of tumor.
Details: There is a growing belief that angiogenesis inhibition represents a potentially promising, novel therapeutic approach to highly vascular solid tumors like malignant gliomas. Thalidomide and IFN are attractive drugs to use in combination to test the hypothesis of combinational anti-angiogenesis inhibition given their proven activity as single agents in patients with malignant gliomas and their spectrum of largely non-overlapping toxicities. Given recent preclinical data describing more potent antiangiogenic and anti-tumor effects of low dose, continuous IFN administration, we are interested in evaluating the use of pegylated IIFN alone or in combination with thalidomide. Thus, we are proposing a randomized phase II trial of pegylated IFN with or without thalidomide in patients with recurrent gliomas.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: 1. Patients with histologically proven supratentorial malignant primary gliomas will be eligible for this protocol. These include glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified). 2. Patients must have evaluable or measurable disease and have shown unequivocal evidence for tumor recurrence or progression by MRI or CT scan. This scan should be preformed within 14 days prior to registration and on a steroid dosage that has been stable for at least 5-7 days. If the steroid dose is increased between the date of imaging and the initiation of PEG-Intron with or without thalidomide, a new baseline MR/CT scan is required. The same type of scan, i.e., MRI or CT must be used throughout the period of treatment for tumor measurement. 3. Patients having undergone recent resection of recurrent or progressive tumor will be eligible as long as the following conditions apply: a.) They have recovered from the effects of surgery b.) Measurable disease following resection of recurrent tumor is not mandated for eligibility into the study. Patients must have evaluable disease. c.) To best assess the extent of residual disease post-operatively, a CT/MRI should be done no later than 96 hours in the immediate post-operative period or 4-6 weeks post-operatively. If the 96 hour scan is more than 2 weeks from registration, the scan needs to be repeated. d.) The baseline on-study MR/CT is performed within 14 days of registration and on a steroid dosage that has been stable. If the steroid dose is increased between the date of imaging and the initiation of Peg-Intron with or without Thalidomide, a new baseline MR/CT is required on stable steroids for 5-7 days. 4. Patient must have failed prior radiation therapy and must have an interval of greater than or equal to 4 weeks from the completion of radiation therapy to start entry. 5. Patients with prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation of true progressive disease rather than radiation necrosis based upon either PET or Thallium scanning, MR spectroscopy or surgical documentation of disease. 6. Prior therapy Patients may have had treatment for no more than two prior relapses. 7. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must be registered in the NABTC DMC Database prior to treatment with study drug. 8. Patients must be greater than or equal to 18 years old, and with a life expectancy greater than 8 weeks. 9. Patients must have a Karnofsky performance status of greater than or equal to 60. 10. Patients must have recovered from the toxic effects of prior therapy (including resolution of effects on laboratory values): 4 weeks from prior cytotoxic therapy, 2 weeks from vincristine, 6 weeks from nitrosoureas, 3 weeks from procarbazine administration, and 1 week for non-cytotoxic agents e.g. tamoxifen, cis-retinoic acid, etc. (radiosensitizer does not count). Any questions related to the definition of non-cytotoxic agents should be directed to the Study Chair. 11. Patients must have adequate bone marrow function (WBC greater than or equal to 3,000 /I, ANC greater than or equal to 1,500 mm(3), platelet count of greater than or equal to 100,000/mm(3), and hemoglobin greater than or equal to 10 gm%), adequate liver function (SGOT and bilirubin greater than 2 times the upper limit of normal), and adequate renal function (creatinine less than 1.5 mg/dL or creatinine clearance greater than or equal to 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion. EXCLUSION CRITERIA: 12. Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix, unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible. 13. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects, Males and females will be recruited with no preference to gender. No exclusion to this study will be based on race. Minorities will actively be recruited to participate. 14. Patients must not be pregnant or nursing, and all patients (both men and women) must be willing to practice birth control for 1 month prior, during and for 4 months after treatment with thalidomide. It has been proposed that thalidomide may interfere with hormonal-based contraception, therefore, barrier methods of contraception (i.e. diaphragm, condom) MUST be used rather than, or in addition to birth control pills. 15. No peripheral neuropathy greater than grade 1. 16. No concurrent use of other investigational agents. 17. Patients must not have: Serious active infection Disease that will obscure toxicity or dangerously alter drug metabolism Serious intercurrent medical illness Significant illness that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patients ability to tolerate this therapy. 18. Patients must not have received prior therapy with Peg-Intron or Thalidomide.
Total Enrollment: 96
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030002; 03-C-0002
Study Start Date: October 11, 2002
Record last reviewed: September 9, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047879
Other Glioma Studies:
1. Genetic Analysis of Brain Tumors
2. Phase I Trial of Intramural Injection of DTI-015 for Recurrent Malignant Gliomas
3. Safety and effectiveness study of G207, a tumor-killing virus, in patients with recurrent brain cancer
4. Safety and tolerability study of 131I-TM-601 to treat adult patients with recurrent glioma.
5. STI571 to Treat Malignant Brain Tumors
Related Studies:
Other Glioma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Phase II Trial of Peginterferon alpha-2b and Thalidomide in Adults with Recurrent Gliomas
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