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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002788 |
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.
Condition | Intervention | Phase |
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Leukemia |
Biological: filgrastim Drug: cyclophosphamide Drug: dexamethasone Drug: etoposide Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A PILOT STUDY OF TOTAL BODY IRRADIATION AND CYCLOPHOSPHAMIDE FOLLOWED BY AUTOLOGOUS TRANSPLANTATION WITH CD34 SELECTED PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA |
Estimated Enrollment: | 15 |
Study Start Date: | October 1995 |
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.
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.
Ages Eligible for Study: | 17 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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)
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
PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior radiation therapy to chest or abdomen greater than 2,000 Gy
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109 |
Study Chair: | David G. Maloney, MD, PhD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000064852, FHCRC-962.00, NCI-H96-0925 |
Study First Received: | August 3, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002788 History of Changes |
Health Authority: | United States: Federal Government |
stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia refractory chronic lymphocytic leukemia B-cell chronic lymphocytic leukemia |
Anti-Inflammatory Agents Dexamethasone Leukemia, Lymphoid Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Cyclophosphamide Etoposide phosphate Hormones Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, Chronic Etoposide |
Alkylating Agents Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immunosuppressive Agents Glucocorticoids Lymphatic Diseases Chronic Lymphocytic Leukemia Antineoplastic Agents, Alkylating Peripheral Nervous System Agents Lymphoproliferative Disorders Leukemia, B-Cell Antirheumatic Agents |
Anti-Inflammatory Agents Dexamethasone Leukemia, Lymphoid Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Cyclophosphamide Hormones Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Alkylating Agents |
Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Gastrointestinal Agents Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Autonomic Agents Myeloablative Agonists Peripheral Nervous System Agents Antineoplastic Agents, Alkylating Lymphoproliferative Disorders |