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Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma Clinical research trials and Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma. Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma clinical trial. Test subjects typically obtain the finest healthcare available for their Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma  Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
For Condition: adult brain stem glioma,high-grade childhood cerebral astrocytoma,adult glioblastoma multiforme,adult anaplastic astrocytoma,adult anaplastic oligodendroglioma
Status: No longer recruiting
Sponsor(s): Kaplan 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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining carboplatin, temozolomide, and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma.
Details: OBJECTIVES: - Determine the response rate in patients with newly diagnosed high-grade glioma treated with temozolomide, carboplatin, and filgrastim (G-CSF). - Determine the toxicity of this treatment regimen in these patients. - Determine the rate of tumor progression in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients are stratified according to disease category (glioblastoma multiforme vs anaplastic astrocytoma vs several other high-grade mixed gliomas). Patients receive carboplatin IV over 4 hours on days 1-2; oral temozolomide every 12 hours on days 1-5; and filgrastim (G-CSF) subcutaneously or IV daily starting no earlier than day 7 and continuing until blood counts recover. Treatment repeats every 28 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 102-222 (17-37 per each of 6 strata) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /64 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed glioblastoma multiforme or anaplastic astrocytoma - Residual tumor on postoperative MRI - Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: - Under 65 Performance status: - Karnofsky or Lansky 70-100% OR - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3 - Hemoglobin at least 8 g/dL (transfusion allowed) - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - SGPT no greater than 3 times ULN Renal: - Age 5 years and under: Creatinine less than 1.2 mg/dL - Age over 5 to 10 years: Creatinine less than 1.5 mg/dL - Age over 10 to 15 years: Creatinine less than 1.8 mg/dL - Age over 15 years: Creatinine less than 2.4 mg/dL Cardiovascular: - No myocardial infarction within the past 6 months Other: - No other concurrent serious medical condition that would preclude study - Able to tolerate oral medications - No prior malignancy for which patient received prior chemotherapy or spinal irradiation - No history of severe allergic reaction to platinum-containing compounds - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 72 hours since prior filgrastim (G-CSF) Chemotherapy: - No prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - Concurrent steroids for tumor-related cerebral edema allowed - No concurrent corticosteroids for solely antiemetic purposes Radiotherapy: - No prior or concurrent radiotherapy Surgery: - Recovered from prior surgery - No concurrent surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JonathanFinlay, Study Chair, Kaplan Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: CDR0000068203; NCI-G00-1856,NYU-0029H,NYU-0004H
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006263
Other Adult Anaplastic Astrocytoma Studies:
1. Brachytherapy in Treating Patients With Recurrent Malignant Glioma
2. Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
3. Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma
4. Suramin in Treating Patients With Recurrent Primary Brain Tumors
5. Taurolidine in Treating Patients With Recurrent or Progressive Glioma
Related Studies:
Other adult anaplastic astrocytoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
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