Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00006367
First received: October 4, 2000
Last updated: June 15, 2010
Last verified: June 2010
  Purpose

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 cancer cells.

PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelofibrosis.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Biological: filgrastim
Drug: busulfan
Drug: cytarabine
Drug: idarubicin
Procedure: peripheral blood stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Autologous Peripheral Blood Stem Cell Mobilization and Transplantation for Myelofibrosis

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Study Start Date: May 2000
Study Completion Date: January 2004
Detailed Description:

OBJECTIVES: I. Determine the ability of myeloablative chemotherapy followed by peripheral blood stem cell (PBSC) transplantation to restore effective marrow hematopoieses in patients with advanced idiopathic myelofibrosis or myelofibrosis secondary to other myeloproliferative disorders. II. Determine the ability of this regimen to palliate symptoms and prolong survival in these patients. III. Determine if there is evidence of clonal hematopoieses before PBSC mobilization, in the PBSC product, and after transplantation in these patients. IV. Correlate the properties of the peripheral blood before mobilization and the PBSC product with engraftment in these patients. V. Correlate the markers of angiogenesis with clinical parameters in these patients.

OUTLINE: Patients with evidence of leukemic progression receive cytoreduction therapy consisting of idarubicin IV on days 1-3 and cytarabine IV continuously over days 1-7 followed by filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover and leukapheresis is completed. Patients undergo leukapheresis beginning when blood counts recover and continuing until the target number of cells are collected. Patients with no evidence of leukemic progression receive filgrastim SC daily until leukapheresis is completed. Patients undergo leukapheresis beginning on day 4 and continuing until the target number of cells are collected. Patients receive myeloablative therapy consisting of oral busulfan every six hours on days -5 to -2. Patients with leukemic progression begin myeloablative therapy at least 28 days after completion of chemotherapy. Patients receive autologous peripheral blood stem cells IV on day 0. Patients are followed at 1 month, 3 months, 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 10-44 patients will be accrued for this study within 2 years.

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Diagnosis of idiopathic myelofibrosis or other myeloproliferative disorder with myelofibrosis Evidence of advanced disease or hematologic abnormalities due to severe fibrosis such as 1 or more of the following poor prognostic factors: Hemoglobin less than 10 g/dL Platelet count less than 100,000/mm3 WBC less than 4,000/mm3 Symptomatic splenomegaly Constitutional symptoms inadequately controlled with low dose chemotherapy Abnormal karyotype Patients without evidence of advanced disease undergo PBSC harvest and transplantation is delayed until there is evidence of disease progression Leukemia progression (greater than 15% peripheral blood blasts) allowed if the history of a chronic myeloproliferative disorder of at least 6 months duration is well documented Ineligible for or refusal of allogeneic transplantation No other cause of myelofibrosis other than myeloproliferative disorders, such as the following: Metastatic carcinoma Lymphoma Hairy cell leukemia Myelodysplastic syndrome De novo acute leukemia Collagen vascular disorders Granulomatous infections

PATIENT CHARACTERISTICS: Age: 75 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics WBC no greater than 30,000/mm3 (may be reduced to less than 30,000/mm3 using hydroxyurea or induction chemotherapy) Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN)* Transaminases no greater than 2 times ULN* * Unless due to extramedullary hematopoiesis in the liver Renal: Creatinine no greater than 2 times normal OR Creatinine clearance at least 50% Cardiovascular: No prior or active congestive heart failure* LVEF at least 50%* *If receiving study cytoreductive therapy Pulmonary: Total lung capacity at least 50% predicted OR Corrected DLCO at least 50% predicted Other: No active infection No poorly controlled seizure disorders Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 7 days since prior hydroxyurea Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006367

Locations
United States, Alaska
Katmai Oncology Group
Anchorage, Alaska, United States, 99508-4627
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Illinois
University of Illinois College of Medicine
Chicago, Illinois, United States, 60612
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
United States, New York
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
France
Hopital Saint-Louis
Paris, France, 75475
United Kingdom
Addenbrooke's NHS Trust
Cambridge, England, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: Jeanne E. Anderson, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00006367     History of Changes
Other Study ID Numbers: 1006.00, FHCRC-1006.00, MCC-12245, MCC-IRB-5698, NCI-G00-1866, CDR0000068240
Study First Received: October 4, 2000
Last Updated: June 15, 2010
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
polycythemia vera
chronic idiopathic myelofibrosis
essential thrombocythemia

Additional relevant MeSH terms:
Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Busulfan
Cytarabine
Idarubicin
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 15, 2014