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High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors 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 High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Clinical research trials and High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors 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 High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors. High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors 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 High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors clinical trial. Participants oftentimes recieve the most expert healthcare available for their High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors 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.
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Home > "H" Clinical Trials Conditions > High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors  High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
For Condition: Testicular Cancer,Brain Tumor,Eye Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering 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. PURPOSE: Phase II trial to study the effectiveness of high-dose thiotepa plus peripheral stem cell transplantation in treating patients with refractory solid tumors.
Details: OBJECTIVES: I. Evaluate the efficacy and toxicity of sequential cycles of high dose thiotepa with stem cell rescue and filgrastim in patients with malignancies refractory to conventional chemotherapy or for whom conventional therapy is not available. II. Evaluate the effectiveness of autologous stem cells in restoring hematopoiesis following high dose thiotepa. PROTOCOL OUTLINE: Patients are stratified by type of tumor (neuroectodermal CNS tumor vs non-neuroectodermal CNS tumor vs non-CNS small round blue cell tumor vs other non-CNS tumor). Autologous stem cells are obtained prior to the administration of thiotepa. Patients who do not have peripheral blood stem cells available may undergo a bone marrow harvest instead. Thiotepa is administered as a 3 hour infusion daily for 3 consecutive days. Stem cells are reinfused approximately 72 hours following the completion of thiotepa. Filgrastim is administered the day following reinfusion of stem cells and continues until there is sufficient hematopoietic recovery. The second course of thiotepa is administered 4 weeks following the first course in patients who have responding or stable disease, adequate stem cells, and no unacceptable toxicity. Patients receive a maximum of 2 courses. PROJECTED ACCRUAL: Approximately 36 patients will be accrued for this study over 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Malignant solid tumors Must have failed conventional treatment or for whom conventional therapy is not available Measurable disease by MRI or CT scan - Intraocular retinoblastomas may be measured by direct visualization - Germ cell tumors may be measured by tumor markers No known bone marrow involvement --Prior/Concurrent Therapy-- Biologic therapy: Prior bone marrow or peripheral blood stem cell rescue allowed Chemotherapy: - At least 4 weeks since prior chemotherapy if absolute neutrophil count is less than 1,000/mm3 or platelet count is less than 75,000/mm3, and recovered (i.e. adequate stem cells collected to predict hematopoietic recovery) - No concurrent chemotherapy except for dexamethasone for antiedema effects Endocrine therapy: No concurrent use of corticosteroids used solely as antiemetics Radiotherapy: - At least 4 weeks since radiotherapy if absolute neutrophil count is less than 1,000/mm3 or platelet count is less than 75,000/mm3, and recovered (i.e. adequate stem cells collected to predict hematopoietic recovery) - No concurrent radiotherapy Surgery: Not specified --Patient Characteristics-- Age: Any age Performance status: - Lansky 60-100% for patients 16 and under - Karnofsky 60-100% for patients over 16 Life expectancy: At least 8 weeks Hematopoietic: - Absolute neutrophil count at least 1,000/mm3 - Platelet count at least 75,000/mm3 - If parameters not met, must have adequate stem cell yield Hepatic: - Bilirubin no greater than 1.5 times the upper limit of normal (ULN) - SGOT and SGPT no greater than 2.5 times the ULN (unless liver involvement by tumor) Renal: - Creatinine within normal limits OR - Creatinine clearance at least 70 mL/min Cardiovascular: - Fractional shortening greater than 28% on echocardiogram OR - Ejection fraction at least 55% on RNCA prior to first cycle of thiotepa Pulmonary: DLCO greater than 55% of predicted (only required if there is clinical evidence of pulmonary dysfunction) Other: - Not pregnant or nursing - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
IraDunkel, Study Chair, Memorial Sloan-Kettering Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000065980; MSKCC-97089A3,NCI-G97-1366,NYU-97-7
Study Start Date: September 1997
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003173
Other Eye Cancer Studies:
1. Calcitriol Plus Carboplatin in Treating Patients With Advanced Solid Tumors
2. Busulfan in Treating Children and Adolescents With Refractory CNS Cancer
3. Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
4. Melphalan in Patients With Neoplastic Meningitis
5. Genetic Study in Patients Receiving Treatment for Hodgkin's Disease or Childhood Brain Tumor
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High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
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