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High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer Clinical research trials and High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer healthcare trials occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer. High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer clinical trial. Participants typically obtain the most effective healthcare available for their High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer  High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer
High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer
For Condition: ovarian sarcoma,Bone Cancer,Breast Cancer,Leukemia,ovarian epithelial cancer,Lymphoma,Multiple Myeloma
Status: No longer recruiting
Sponsor(s): University of Kentucky ,
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 chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation and amifostine in treating patients with cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of high dose melphalan with autologous peripheral blood stem cell support and amifostine cytoprotection in patients with cancer. II. Determine the complete response rate, event free survival, overall survival, and nonrelapse mortality in this patient population. PROTOCOL OUTLINE: This is a dose escalation study of melphalan. Prior to high dose melphalan and amifostine cytoprotection, patients may receive cyclophosphamide IV. Filgrastim (G-CSF) is given until cytapheresis is completed. Patients receive high dose melphalan according to an escalating dose schedule. High dose melphalan is administered IV on day -1. Amifostine is also administered on days -2 and -1. Peripheral blood stem cell transplantation is performed on day 0. Dose escalation of high dose melphalan continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose limiting toxicity. After the MTD of high dose melphalan is determined, additional patients are treated at this dose level. Patients are followed at days 30, 100, 365, and yearly thereafter. PROJECTED ACCRUAL: After the determination of MTD, a total of 14-25 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 14 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Confirmed diagnosis of primary tumor and/or recurrence that has a low curative potential using other therapies, including but not limited to: Acute leukemia; Myeloma; Breast cancer; Ovarian cancer; Hodgkin's disease; Non-Hodgkin's lymphoma; Neuroblastoma; Ewing's sarcoma - In the absence of recurrence, malignancies for which an autotransplant regimen is considered a reasonable therapeutic alternative are also considered - Greater than 25% of bone marrow normal cellularity and less than 10% of volume composed of tumor cells - No active brain metastases or carcinomatous meningitis (controlled CNS metastases eligible) --Prior/Concurrent Therapy-- - Biologic therapy: No more than 1 prior autologous peripheral blood stem cell transplant - Chemotherapy: Cumulative anthracycline or equivalent dose no greater than 450 mg/m2 - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: Not specified - Other: Recovered from prior therapy; No antihypertensives during and 24 hours prior to amifostine administration --Patient Characteristics-- - Age: 14 to 70 - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC greater than 3000/mm3; Absolute neutrophil count greater than 1500/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin, SGOT, and SGPT less than 2 times normal - Renal: Creatinine clearance greater than 60 mL/min - Cardiovascular: LVEF at least 45% - Pulmonary: DLCO at least 50% FEV1 at least 60% - Other: Not pregnant or nursing; Fertile patients must use effective contraception; HIV, HTLV-1, and HTLV-2 negative; Hepatitis B and C negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DonnaReece, Study Chair, University of Kentucky
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Additional Information:
Study ID Numbers: CDR0000066448; UKMC-97BMT72,NCI-V98-1455,ALZA-UKMC-97BMT72
Study Start Date: July 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003425
Other Ovarian Epithelial Cancer Studies:
1. Randomized double cord blood transplant study
2. Total-Body Irradiation, Tacrolimus, and Mycophenolate Mofetil Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
3. Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
4. Anti-Angiogenesis Therapy Using Thalidomide in Multiple Myeloma
5. T Cell Immunotherapy for Multiple Myeloma Patients Undergoing a Bone Marrow Transplant
Related Studies:
Other ovarian epithelial cancer Clinical Trials
Other Kentucky Clinical Trials
Other Lexington Clinical Trials
High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer
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