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Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors Clinical research trials and Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors healthcare trials happen in many 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 generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors. Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors  Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
For Condition: Testicular Cancer,childhood soft tissue sarcoma,Eye Cancer,kidney tumor,adult soft tissue sarcoma,ovarian sarcoma,childhood liver cancer,Bone Cancer,Brain Tumor
Status: No longer recruiting
Sponsor(s): University of Minnesota Cancer Center ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of high-dose chemotherapy. PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors.
Details: OBJECTIVES: I. Determine the dose-limiting toxicity of amifostine chemoprotection with peripheral blood stem cell transplantation plus chemotherapy in patients with high-risk or relapsed solid tumors or brain tumors. II. Determine response or time to disease progression in patients treated with this regimen. PROTOCOL OUTLINE: This is a dose-escalation study of amifostine. Patients are stratified according to age (1 to 18 vs 19 to 45 years). All patients receive filgrastim (G-CSF) IV for 1 week. On day 6 of G-CSF administration, patients undergo peripheral blood stem cell (PBSC) harvest followed by chemotherapy. Patients receive oral busulfan every 6 hours on days -8 to -6 followed by melphalan IV over 30 minutes on days -5 and -4 and thiotepa IV over 2 hours on days -3 and -2. Patients receive amifostine IV over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1. PBSC are reinfused on day 0. Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed on day 50; at 3, 6, and 9 months; and at 1, 2, and 3 years post PBSC transplantation. PROJECTED ACCRUAL: A maximum of 60 patients (30 per stratum) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 1 Year/45 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed high-risk or relapsed solid tumors or brain tumors, including: - Metastatic or relapsed Ewing's sarcoma - Metastatic or relapsed rhabdomyosarcoma - Refractory Wilms' tumor - Diffuse anaplastic Wilms' tumor - Stage III or IV neuroblastoma - Recurrent retinoblastoma - Metastatic or relapsed germ cell tumors - Metastatic or relapsed other soft tissue sarcomas - Small cell ovarian sarcoma - Metastatic or relapsed primitive neuroectodermal tumors of the bone - Recurrent brain tumors - Desmoplastic small round cell tumors - Recurrent or metastatic chordomas - Metastatic or relapsed hepatoblastoma No osteogenic sarcoma Patients receive peripheral blood stem cell transplantation only if in complete remission or in very good partial remission with no disease progression Must have radiologic, nuclear image, or histologic verification of relapse --Prior/Concurrent Therapy-- Biologic therapy: - At least 1 week since prior hematopoietic growth factor and recovered - No prior bone marrow transplantation Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: - Recovered from any prior therapy - No other concurrent investigational agents --Patient Characteristics-- Age: 1 to 45 Performance status: Karnofsky 70-100% Life expectancy: More than 4 months Hematopoietic: - No uncontrolled bleeding - Absolute neutrophil count greater than 1,000/mm3 - Platelet count greater than 100,000/mm3 - Hemoglobin count at least 10 g/dL Hepatic: - Bilirubin less than 2 times upper limit of normal (ULN) - SGOT or SGPT less than 2.5 times ULN Renal: - Creatinine less than 2 times ULN - Creatinine clearance greater than 70 mL/min Cardiovascular: - Cardiac shortening fraction greater than 30% - Cardiac ejection fraction greater than 45% - No congestive heart failure - No uncontrolled hypertension Pulmonary: No asthma Other: - Not pregnant or nursing - No uncontrolled metabolic disease - No active severe infection - No allergy to aminothiol compounds
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnPerentesis, Study Chair, University of Minnesota Cancer Center
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Additional Information:
Study ID Numbers: CDR0000067114; UMN-MT-9713,NCI-V99-1553,ALZA-UMN-MT-9713,UMN-9712M00074
Study Start Date: November 1998
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003926
Other Testicular Cancer Studies:
1. PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma
2. Stem Cell Transplantation in Treating Patients with Hematologic Cancer
3. Flavopiridol in Treating Patients With Refractory Cancer
4. ZD0473 and Doxorubicin in Treating Patients With Advanced Solid Tumors or Lymphoma
5. Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Related Studies:
Other Testicular Cancer Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis Clinical Trials
Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
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