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High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia Clinical research trials and High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia. High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia clinical trial. Test subjects typically receive the most expert healthcare available for their High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia  High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
For Condition: stage 3 chronic lymphocytic leukemia,B-cell Chronic Lymphocytic Leukemia,stage 4 chronic lymphocytic leukemia,refractory chronic lymphocytic leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of high-dose combination chemotherapy followed by total-body irradiation and peripheral stem cell transplantation in treating patients with chronic lymphocytic leukemia.
Details: OBJECTIVES: I. Evaluate engraftment after autografting with CD34 selected peripheral blood stem cells (PBSC) in patients with chronic lymphocytic leukemia (CLL). II. Evaluate the efficacy of CD34 selection for purging CLL from PBSC collection. III. Determine the effectiveness of mobilization chemotherapy with cyclophosphamide, etoposide, and dexamethasone plus filgrastim (granulocyte colony-stimulating factor) to mobilize PBSC in these patients. IV. Describe toxicity and disease response to a conditioning regimen of total body irradiation and cyclophosphamide in these patients. PROTOCOL OUTLINE: There are 3 phases to the treatment plan: Cytoreductive chemotherapy can be given by conventional chemotherapy. Patients are treated until at least a good partial remission. Patients will have CD34 selected peripheral blood stem cells (PBSC) stored after treatment with mobilization chemotherapy followed by filgrastim (granulocyte colony-stimulating factor; G-CSF). Cyclosphosphamide (CTX) IV is given over 1 hour. Etoposide (VP-16) is given over 1-2 hours on day 2. Dexamethasone is given 4 times a day on days 1-3. G-CSF is given subcutaneously daily beginning 2 days after chemotherapy and continuing until PBSC collection is completed. At least 4 weeks should ensue after mobilization chemotherapy before proceeding with the transplant. Patients are treated with TBI on days -6, -5, and -4 and CTX on days -3 and -2. PBSC are infused on day 0. PROJECTED ACCRUAL: A total of 15 patients will be entered in this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 17 Years/65 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnostically proven intermediate, advanced, or high risk chronic lymphocytic leukemia of the B cells with marrow tumor reduced by prior therapy - Marrow tumor content no greater than 30% of total nucleated cells - Patients age 50 and under who have high risk disease are eligible - Patients age 65 and under who have intermediate or high risk disease that has failed at least 1 therapy including an alkylating agent or fludarabine are eligible - No history of transformation to aggressive lymphoma (Richter's syndrome) --Prior/Concurrent Therapy-- - See Disease Characteristics No prior radiation therapy to chest or abdomen greater than 2,000 Gy --Patient Characteristics-- - Age: 17 to 65 - Performance status: Karnofsky 70%-100% - Life expectancy: Not severely limited by illness other than leukemia - Hematopoietic: Absolute neutrophil count greater than 2,000/mm3 (no growth factor support); Platelet count greater than 120,000/mm3 (unless documented active autoimmune thrombocytopenia); Hemoglobin greater than 10 g/dL (unless documented active autoimmune anemia) No coexisting myelodysplasia - Hepatic: Bilirubin no greater than 2.0 mg/dL - Renal: Creatinine clearance at least 50 mL/min - Cardiovascular: No cardiac disease that would limit ability to receive cytoreductive therapy and compromise survival - Pulmonary: No pulmonary disease that would limit ability to receive cytoreductive therapy and compromise survival - Other: No HIV antibody; Not pregnant
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidMaloney, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States
Additional Information:
Study ID Numbers: CDR0000064852; FHCRC-962.00,NCI-H96-0925
Study Start Date: October 1999
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002788
Other Stage 4 Chronic Lymphocytic Leukemia Studies:
1. Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia
2. High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
3. Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia
4. Cladribine and Rituximab as Remission Induction Therapy Followed By Rituximab and Stem Cell Mobilization in Treating Patients With Chronic Lymphocytic Leukemia
5. Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia
Related Studies:
Other stage 4 chronic lymphocytic leukemia Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
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