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Temozolomide in Treating Patients With Anaplastic Oligodendroglioma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Temozolomide in Treating Patients With Anaplastic Oligodendroglioma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Temozolomide in Treating Patients With Anaplastic Oligodendroglioma Clinical research trials and Temozolomide in Treating Patients With Anaplastic Oligodendroglioma healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Temozolomide in Treating Patients With Anaplastic Oligodendroglioma. Temozolomide in Treating Patients With Anaplastic Oligodendroglioma Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Temozolomide in Treating Patients With Anaplastic Oligodendroglioma clinical trial. Human subjects often receive the most effective healthcare possible for their Temozolomide in Treating Patients With Anaplastic Oligodendroglioma condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Temozolomide in Treating Patients With Anaplastic Oligodendroglioma  Temozolomide in Treating Patients With Anaplastic Oligodendroglioma
Temozolomide in Treating Patients With Anaplastic Oligodendroglioma
For Condition: recurrent adult brain tumor,adult anaplastic oligodendroglioma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Duke Comprehensive Cancer Center
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 anaplastic oligodendroglioma.
Details: OBJECTIVES: I. Define the activity of temozolomide in the treatment of adults with newly diagnosed, progressive, or recurrent anaplastic oligodendroglioma. II. Define the toxicity of temozolomide in this patient population. PROTOCOL OUTLINE: Patients are stratified according to disease characteristics (newly diagnosed anaplastic oligodendroglioma versus recurrent anaplastic oligodendroglioma). Patients receive oral temozolomide once a day for 5 consecutive days. Courses are repeated every 28 days. For patients with newly diagnosed disease, therapy continues in the absence of disease progression or unacceptable toxic effects for a maximum of 4 courses prior to radiotherapy. If the disease is responding, patients may receive an additional 6 courses of temozolomide following completion of radiotherapy. (Radiotherapy is not part of study treatment.) For patients with progressive or recurrent disease, treatment continues in the absence of disease progression or unacceptable toxic effects. Patients are followed every 8 weeks for 2 years. PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed supratentorial anaplastic oligodendroglioma or anaplastic oligoastrocytoma not requiring immediate radiation therapy; Newly diagnosed, progressive, or recurrent - Bidimensionally measurable disease; Lesion must be at least 1.5 cm2 documented by MRI --Prior/Concurrent Therapy-- - Biologic therapy: No more than 1 prior biologic therapy allowed; No concurrent biologic therapy; No concurrent growth factors (e.g., erythropoietin) - Chemotherapy: No more than 1 prior chemotherapy regimen allowed; No concurrent chemotherapy - Endocrine therapy: Must be on stable dose of steroids for at least 1 week prior to study; Concurrent steroids allowed - Radiotherapy: See Disease Characteristics; No concurrent radiation therapy - Surgery: At least 2 weeks since prior surgical resection (newly diagnosed patients must be enrolled within 28 days of surgery or biopsy); Recovered from major surgery - Other: No other concurrent investigational drugs --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: Greater than 12 weeks - Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN); SGOT/SGPT less than 2.5 times ULN; Alkaline phosphatase less than 2 times ULN - Renal: BUN less than 1.5 times ULN; Creatinine less than 1.5 times ULN - Neurologic: Must be neurologically stable - Other: No nonmalignant systemic disease; No acute infection treated with intravenous antibiotics; No frequent vomiting; No medical condition that could interfere with oral medication intake (e.g., partial bowel obstruction); No prior or concurrent malignancies at other sites except surgically cured carcinoma in situ of the cervix and basal or squamous cell carcinoma of the skin; Not HIV positive; No AIDS related illness; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HenryFriedman, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000066501; DUMC-1534-00-8R3,NCI-G98-1468,DUMC-1372-97-9,DUMC-1403-98-9R1,DUMC-1550-99-9R2,DUMC-97104
Study Start Date: March 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003465
Other Adult Anaplastic Oligodendroglioma Studies:
1. Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
2. Brachytherapy in Treating Patients With Recurrent Malignant Glioma
3. Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
4. Bortezomib in Treating Patients With Recurrent Glioma
5. Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
Related Studies:
Other adult anaplastic oligodendroglioma Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Temozolomide in Treating Patients With Anaplastic Oligodendroglioma
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