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Temozolomide in Treating Patients With Progressive Low-Grade Glioma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Temozolomide in Treating Patients With Progressive Low-Grade Glioma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Temozolomide in Treating Patients With Progressive Low-Grade Glioma Clinical research trials and Temozolomide in Treating Patients With Progressive Low-Grade Glioma healthcare trials take place in many of cities across 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 generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Temozolomide in Treating Patients With Progressive Low-Grade Glioma. Temozolomide in Treating Patients With Progressive Low-Grade Glioma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Temozolomide in Treating Patients With Progressive Low-Grade Glioma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Temozolomide in Treating Patients With Progressive Low-Grade Glioma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Temozolomide in Treating Patients With Progressive Low-Grade Glioma  Temozolomide in Treating Patients With Progressive Low-Grade Glioma
Temozolomide in Treating Patients With Progressive Low-Grade Glioma
For Condition: adult brain tumor,childhood cerebral astrocytoma and malignant glioma,Childhood Oligodendroglioma,childhood visual pathway and hypothalamic glioma,childhood brain tumor,childhood brain stem glioma
Status: Recruiting
Sponsor(s): Duke Comprehensive Cancer Center , 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 II trial to study the effectiveness of temozolomide in treating patients with progressive low-grade glioma.
Details: OBJECTIVES: - Assess the response rate in patients with progressive low-grade gliomas treated with temozolomide. - Determine the activity of this drug, in terms of stabilizing growth of progressive low-grade gliomas, in adult patients. OUTLINE: Patients are stratified by disease type (pilocytic astrocytoma, mixed glioma, well-differentiated oligodendroglioma, and nonbiopsied optic pathway glioma or pontine glioma). Patients receive temozolomide orally once daily on days 1-5. Courses repeat every 28 days. In the absence of disease progression or unacceptable toxicity, patients may continue with treatment until tumor has remained stable for 12 courses. Patients are followed every 8-12 weeks for 2 years. PROJECTED ACCRUAL: A total of 36-100 patients (9-25 per stratum) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 4 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed progressive, primary, intracranial, supratentorial, low-grade glioma including: - Astrocytoma - Oligodendroglioma - Mixed glioma - Optic pathway glioma* - Pontine glioma* NOTE: *Biopsy not required - Patients with optic pathway glioma must also meet the following criteria: - Progressive loss of vision as defined by doubling of octaves - Visual acuity loss not explained by other causes - Increase in proptosis of greater than 3 mm - Increase in diameter of optic nerve of at least 2 mm on neuroimaging - Increase in distribution of tumor involving optic tracts or optic radiations as indicated by CT scan or MRI PATIENT CHARACTERISTICS: Age: - 4 and over Performance status: - Karnofsky 70-100% Life expectancy: - More than 12 weeks Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGOT and SGPT less than 2.5 times ULN - Alkaline phosphatase less than 2 times ULN Renal: - Creatinine less than 1.5 times ULN - BUN less than 1.5 times ULN Other: - Must be neurologically stable - No systemic disease - No acute infection requiring IV antibiotics - No frequent vomiting - No other medical condition that would interfere with oral medication (e.g., partial bowel obstruction) - No other prior or concurrent malignancies except: - Surgically cured carcinoma in situ of the cervix - Basal or squamous cell skin cancer - HIV negative - No AIDS-related illness - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent biologic therapy (growth factors or epoetin alfa) Chemotherapy: - At least 6 weeks since prior chemotherapy unless evidence of disease progression - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 6 weeks since prior radiotherapy unless evidence of disease progression - No concurrent radiotherapy Surgery: - At least 3 weeks since prior surgery unless evidence of disease progression - Recovered from all prior surgery Other: - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HenryFriedman, Study Chair, Duke Comprehensive Cancer Center
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Peter Phillips 215-590-2107
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Henry Friedman 919-684-5301
Additional Information:
Study ID Numbers: CDR0000066502; DUMC-1703-02-9R5,DUMC-000693-01-3R1,DUMC-1703-01-94R,DUMC-1502-97-10,DUMC-1569-98-10R1,DUMC-97125,NCI-G98-1469
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003466
Other Childhood Visual Pathway And Hypothalamic Glioma Studies:
1. Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors
2. Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors
3. DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
4. Temozolomide and O6-Benzylguanine in Treating Children With Recurrent Brain Tumors
5. Chemotherapy and Stem Cell Transplantation in Treating Children with Central Nervous System Cancer
Related Studies:
Other childhood visual pathway and hypothalamic glioma Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Temozolomide in Treating Patients With Progressive Low-Grade Glioma
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