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Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma Clinical research trials and Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma. Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma clinical trial. Participants frequently get the best healthcare available for their Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma  Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma
Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma
For Condition: recurrent adult brain tumor,Thrombocytopenia,adult anaplastic astrocytoma,adult glioblastoma multiforme
Status: Recruiting
Sponsor(s): Oregon Health and Science University , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and etoposide phosphate, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells. Chemoprotective drugs, such as sodium thiosulfate, may protect blood platelets from the side effects of chemotherapy. PURPOSE: Randomizedphase II trial to compare the effectiveness of combining carboplatin, cyclophosphamide, and etoposide or etoposide phosphate with or without sodium thiosulfate in treating patients who have high-gradeglioma.
Details: OBJECTIVES: Primary - Determine the effect of delayed administration of high-dose sodium thiosulfate on platelet counts in patients with high-grade glioma undergoing treatment with intra-arterial carboplatin, cyclophosphamide, and etoposide or etoposide phosphate. Secondary - Determine the effect of delayed administration of high-dose sodium thiosulfate on granulocyte and erythrocyte counts in patients treated with this chemotherapy regimen. - Determine the tumor response in patients treated with this chemotherapy regimen with or without delayed high-dose sodium thiosulfate. - Determine hearing changes at higher frequencies in the standard testing range (i.e., 4,000 and 8,000 Hz) and at higher frequencies above standard testing range (i.e., 9,000 and 16,000 Hz) in patients treated with these regimens. - Determine the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology type (glioblastoma multiforme vs anaplastic astrocytoma). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive cyclophosphamide IV over 10 minutes, etoposide phosphate IV over 10 minutes (or etoposide IV), and carboplatin intra-arterially over 10 minutes on day 1. Beginning on day 3, patients receive filgrastim (G-CSF) subcutaneously once daily for 7-10 days until blood counts recover. - Arm II: Patients receive cyclophosphamide, etoposide phosphate or etoposide, carboplatin, and G-CSF as in arm I. At 4 and 8 hours after carboplatin administration, patients receive high-dose sodium thiosulfate IV over 15 minutes. In both arms, treatment repeats every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 6 months during study treatment, and then within 30 days after the final study treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed high-grade glioma by needle biopsy, open biopsy, or surgical resection - No rapidly progressing CNS disease with associated neurological deterioration PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - ECOG 0-2 OR - Karnofsky 50-100% Life expectancy - Not specified Hematopoietic - WBC at least 2,500/mm^3 - Absolute granulocyte count at least 1,200/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin less than 2.0 mg/dL - SGOT/SGPT less than 2.5 times upper limit of normal Renal - Creatinine less than 1.8 mg/dL Cardiovascular - Adequate cardiovascular function to tolerate monitored anesthesia Pulmonay - Adequate pulmonary function to tolerate monitored anesthesia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for at least 2 months before and during study participation - No uncontrolled clinically significant confounding medical condition within the past 30 days - No contraindication to the study medications PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 2 weeks since prior focal or systemic radiotherapy Surgery - Prior surgery or biopsy allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EdwardNeuwelt, Principal Investigator, Oregon Health and Science University
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Gene Barnett 216-444-1379
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting Edward Neuwelt 503-494-5626
Additional Information:
Study ID Numbers: CDR0000346101; OHSU-ONC-02059-L,OHSU-7328
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075387
Other Recurrent Adult Brain Tumor Studies:
1. Motexafin Gadolinium Plus Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
2. Suramin in Treating Patients With Recurrent Primary Brain Tumors
3. Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
4. Radiation Therapy and Gadolinium Texaphyrin in Treating Patients With Supratentorial Glioblastoma Multiforme
5. EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
Related Studies:
Other recurrent adult brain tumor Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma
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