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Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer Clinical research trials and Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer. Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer  Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer
For Condition: myelodysplastic and myeloproliferative diseases,Lymphoma,Leukemia
Status: Recruiting
Sponsor(s): Fred Hutchinson Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may decrease side effects while stopping cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide combined with total-body irradiation and donor stem cell transplantation in treating patients who have hematologic cancer.
Details: OBJECTIVES: - Determine a safe and reproducible method of adjusting the dose of cyclophosphamide based on its metabolism when given in combination with total body irradiation and hematopoietic stem cell transplantation in patients with hematologic malignancy. OUTLINE: - Preparative regimen: Patients undergo total body irradiation twice daily on days -6 to -4. Patients then receive dose-adjusted (based on metabolism) cyclophosphamide IV over 1 hour on days -3 and -2. - Hematopoietic stem cell (HSC) infusion: Patients undergo allogeneic HSC transplantation on day 0. Patients receive graft-versus-host disease prophylaxis, CNS prophylaxis, and testicular irradiation as per institutional standard practices. Patients are followed daily until day 80 after transplantation and then regularly thereafter for survival. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/65 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of hematological malignancy, including any of the following: - Chronic myeloid leukemia - Acute myeloid leukemia - Acute lymphocytic leukemia - Myelodysplastic syndromes - Lymphoma - Unlikely to respond to conventional treatment and would benefit from hematopoietic stem cell transplantation - No bulky tumor mass requiring additional involved field radiotherapy - No large body burden of tumor cells requiring cytoreductive chemotherapy before total body irraditation and cyclophosphamide - Undergoing conditioning for transplantation at the University of Washington Medical Center - Availability of 1 of the following types of allogeneic donors: - HLA-identical family members - Unrelated donors - Allele match (match grade 1) - One allele mismatch for A, B, C, DRB1 or DQB1 (match grades 2.1 or 2.2) PATIENT CHARACTERISTICS: Age - 18 to 65 Performance status - Not specified Life expectancy - Not severely limited by diseases other than malignancy - Not moribund Hematopoietic - Not specified Hepatic - Bilirubin no greater than 1.2 mg/dL - No cirrhosis - No hepatic fibrosis with bridging Renal - Creatinine no greater than 1.2 mg/dL Cardiovascular - No coronary artery disease - No congestive heart failure requiring therapy Pulmonary - Oxygen saturation at least 93% (on room air) Other - Not pregnant or nursing - Fertile patients must use effective contraception - HIV negative - No concurrent infection requiring systemic antibiotic or antifungal therapy PRIOR CONCURRENT THERAPY: Biologic therapy - No prior hematopoietic stem cell transplantation Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy to the liver or adjacent organs Surgery - Not specified Other - No concurrent aspirin or nonsteroidal anti-inflammatory medications such as ibuprofen (e.g., Motrin® or Advil®) - No other concurrent phase I study enrollment
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeMcDonald, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting George McDonald 206-667-5211
Additional Information:
Study ID Numbers: CDR0000304522; FHCRC-1797.00
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062140
Other Myelodysplastic And Myeloproliferative Diseases Studies:
1. Total-Body Irradiation Plus Chemotherapy Followed By Donor Bone Marrow Transplantation in Treating Children With Hematologic Cancer
2. Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer
3. Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer
4. Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer or Hematologic Cancer
5. Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer or Nonmalignant Hematologic Disease
Related Studies:
Other myelodysplastic and myeloproliferative diseases Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer
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