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Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors Clinical research trials and Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors clinical trial. Participants oftentimes recieve the finest healthcare available for their Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors  Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
For Condition: unspecified childhood solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): Children's Hospital and Medical Center - Seattle , 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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have recurrent or refractory solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of thiotepa in combination with carboplatin and topotecan with peripheral blood stem cell transplantation in patients with recurrent or refractory pediatric solid tumors. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a dose escalation study of thiotepa. Patients may receive 2 courses of mobilization comprising cyclophosphamide and etoposide with filgrastim (G-CSF) support and peripheral blood stem cell (PBSC) collection. Patients receive thiotepa IV over 2 hours on days 0 and 1; topotecan IV over 30 minutes on days 0-4; and carboplatin IV over 2 hours on days 2 and 3. Patients also receive G-CSF beginning on day 5, 24-36 hours following the last dose of topotecan. PBSC are reinfused on day 6 (36-48 hours following the last dose of topotecan) of each course of therapy. Patients receive 3 courses of therapy. Cohorts of 3-6 patients receive escalating doses of thiotepa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 1 and 2 years. PROJECTED ACCRUAL: A maximum of 24 patients will be accrued into this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/30 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven recurrent or refractory pediatric solid tumor - Bone marrow metastases allowed PATIENT CHARACTERISTICS: Age: - 1 to 30 Performance status: - 0-2 Life expectancy: - At least 2 months Hematopoietic: - Absolute neutrophil count at least 1,000/mm3 - Platelet count at least 100,000/mm3 (transfusion independent) - Hemoglobin at least 10 g/dL (RBC transfusion allowed) Hepatic: - Bilirubin no greater than 1.5 times normal - SGOT no greater than 2.5 times normal Renal: - Adequate renal function as defined by one of the following: - GFR by creatinine clearance - Radioisotope GFR - Iothalamate at least 70 mL/min Cardiovascular: - Adequate cardiac function as defined by one of the following: - Ejection fraction at least 55% by MUGA - Fractional shortening at least 28% by echocardiogram Neurologic: - Adequate CNS function as defined by: - Seizure disorder, if present, controlled by anticonvulsants - CNS toxicity no greater than grade 2 Other: - No uncontrolled infections - Not pregnant or nursing - No allergy to platinum compounds - No history of allergy to etoposide (unless mobilization phase not required) PRIOR CONCURRENT THERAPY: Biologic therapy: - Recovered from prior immunotherapy - At least 1 week since prior cytokines - At least 3 months since prior bone marrow or peripheral blood stem cell transplantation - No concurrent immunomodulator - No concurrent cytokines Chemotherapy: - At least 3 weeks (6 for nitrosourea) since prior chemotherapy and recovered - No prior thiotepa - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Recovered from prior radiotherapy - At least 6 months since prior total body irradiation conditioning - No concurrent radiotherapy to greater than 10% of total liver, lung, or bone marrow Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DouglasHawkins, Study Chair, Children's Hospital and Medical Center - Seattle
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Additional Information:
Study ID Numbers: CDR0000066029; CHMC-6006,FHCRC-1244.00,NCI-G98-1373
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003194
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
2. Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
3. Antibiotic Therapy With or Without G-CSF in Treating Children With Neutropenia and Fever Caused by Chemotherapy
4. Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
5. Fenretinide in Treating Children With Solid Tumors
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
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