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High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
This study is ongoing, but not recruiting participants.
First Received: August 3, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002788
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 15
Study Start Date: October 1995
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   17 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002788

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: David G. Maloney, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
refractory chronic lymphocytic leukemia
B-cell chronic lymphocytic leukemia

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 01, 2009