|
Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts after Intensive Chemotherapy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts after Intensive Chemotherapy conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts after Intensive Chemotherapy Clinical research trials and Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts after Intensive Chemotherapy health trials occur in hundreds of cities 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 typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts after Intensive Chemotherapy. Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts after Intensive Chemotherapy Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts after Intensive Chemotherapy clinical trial. Participants oftentimes recieve the most expert healthcare available for their Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts after Intensive Chemotherapy condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts after Intensive Chemotherapy  Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts after Intensive Chemotherapy
Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts after Intensive Chemotherapy
For Condition: Ewing's Sarcoma,Synovial Sarcoma,Rhabdomyosarcoma,Sarcoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Filgrastim (granulocyte colony-stimulating factor), which is administered by daily subcutaneous injection after cytotoxic chemotherapy, shortens the duration of chemotherapy-induced neutropenia and lowers the risk of infection. In children treated with dose-intensive chemotherapy, filgrastim reduces the duration of severe neutropenia and, as a result, has become a standard component of the treatment regimen. Filgrastim-SD/01 (AMGEN), which is produced by PEGylation of the amino-terminus of filgrastim, is a sustained duration form of granulocyte colony-stimulating factor. In phase I and phase II trials in adults, a single dose of Filgrastim-SD/01 appears to be equivalent to daily dosing of filgrastim in enhancing neutrophil recovery and has a comparable adverse event profile. Dose-intensive vincristine/cyclophosphamide/doxorubicin (VDoxC) alternating with ifosfamide/etoposide (IE) has become standard therapy for children and adolescents with Ewing's sarcoma and other sarcomas treated at the POB/NCI and other cancer centers within the US. Supportive care measures used in children who are treated with this regimen include mesna to prevent oxazaphosphorine urotoxicity, dexrazoxane to reduce doxorubicin cardiotoxicity, and filgrastim to shorten the duration of neutropenia. The purpose of this randomized open label trial is to compare the tolerance, toxicity, and therapeutic effects of Filgrastim-SD/01 given as a single injection after chemotherapy to daily subcutaneous filgrastim in patients with newly diagnosed sarcoma. The pharmacokinetics of Filgrastim-SD/01 will also be compared to the pharmacokinetics of filgrastim. This trial will also be a platform for performing biological studies of these tumors and for detailed cardiac studies. High-risk patients who are treated on this front line trial and respond will also be candidates for a planned transplant protocol. A total of 34 patients (17 patients per treatment arm) will be entered onto the trial.
Details: Filgrastim (granulocyte colony-stimulating factor), which is administered by daily subcutaneous injection after cytotoxic chemotherapy, shortens the duration of chemotherapy-induced neutropenia and lowers the risk of infection. In children treated with dose-intensive chemotherapy, Filgrastim reduces the duration of severe neutropenia and, as a result, has become a standard component of the treatment regimen. Filgrastim-SD/01 (AMGEN), which is produced by PEGylation of the amino-terminus of Filgrastim, is a sustained duration form of granulocyte colony-stimulating factor. In phase I and phase II trials in adults, a single dose of Filgrastim-SD/01 appears to be equivalent to daily dosing of Filgrastim in enhancing neutrophil recovery and has a comparable adverse event profile. Dose-intensive vincristine/cyclophosphamide/doxorubicin (VDoxC) alternating with ifosfamide/etoposide (IE) has become standard therapy for children and adolescents with Ewing's sarcoma and other sarcomas treated at the POB/NCI and other cancer centers within the US. Supportive care measures used in children who are treated with this regimen include mesna to prevent oxazaphosphorine urotoxicity, dexrazoxane to reduce doxorubicin cardiotoxicity, and Filgrastim to shorten the duration of neutropenia. The purpose of this randomized open label trial is to compare the tolerance, toxicity, and therapeutic effects of Filgrastim-SD/01 given as a single injection after chemotherapy to daily subcutaneous Filgrastim in patients with newly diagnosed sarcoma. The pharmacokinetics of Filgrastim-SD/01 will also be compared to the pharmacokinetics of Filgrastim. This trial will also be a platform for performing biological studies of these tumors and for detailed cardiac studies. High-risk patients who are treated on this front line trial and respond will also be candidates for a planned transplant protocol. A total of 34 patients (17 patients per treatment arm) will be entered onto the trial.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Newly diagnosed histologically proven: Ewing's sarcoma family of tumors, including peripheral neuroectodermal tumors; Alveolar rhabdomyosarcoma; Stage 3 or 4 embryonal rhabdomyosarcoma; Malignant peripheral nerve sheath tumor that is unresectable, incompletely resected with bulk residual disease or metastatic; Synovial cell sarcoma that is unresectable, incompletely resected with bulk residual disease, or metastatic. Age equal to or less than 25 years at the time of diagnosis. Normal cardiac function (ejection fraction by MUGA or ECHO that is within the institutional normal range). Normal serum creatinine for age or creatinine clearance greater than 60 ml/min/1.73m(2). Normal liver function (SGPT less than 5 times the upper limit of normal and bilirubin less than 2.5 times the upper limit of normal). Normal hematologic function (absolute neutrophil count equal to or greater than 1500/microL, hemoglobin equal to or greater than 9.0 g/dl and platelet count equal to or greater than 100,000/microL). Subjects of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study. EXCLUSION CRITERIA: Previous chemotherapy or radiotherapy. Pregnant or breast feeding. Histological evidence of tumor infiltration of bone marrow. Stage 1 or 2 embryonal rhabdomyosarcomas.
Total Enrollment: 34
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Clinical Support Center/NCI 1-888-624-1937
Additional Information:
Study ID Numbers: 000092; 00-C-0092
Study Start Date: March 3, 2000
Record last reviewed: January 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004853
Other Sarcoma Studies:
1. Magnetic-Targeted Doxorubicin in Treating Patients with Cancer Metastatic to the Liver
2. Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas
3. Vaccination Against Melanoma and Other Cancers
4. Limb Perfusion of Melphalan, with or without Tumor Necrosis Factor, to Treat Inoperable Arm or Leg Cancer
5. Evaluation, Treatment, and Natural History of Children with Cancer
Related Studies:
Other Sarcoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Comparison of Filgrastim and Filgrastim SD/01in Boosting White Cell Counts after Intensive Chemotherapy
|
|
|
|
|
|
|
|
