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Chemotherapy and Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: University of Pennsylvania
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002592
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous bone marrow 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 autologous bone marrow transplantation in treating patients with chronic myelogenous leukemia.


Condition Intervention Phase
Leukemia
Drug: busulfan
Drug: c-myb antisense oligonucleotide G4460
Drug: cyclophosphamide
Drug: filgrastim
Procedure: autologous bone marrow transplantation
Procedure: in vitro-treated bone marrow transplantation
Phase II

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic   

ChemIDplus related topics:   Cyclophosphamide    Filgrastim    Busulfan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   AUTOLOGOUS BONE MARROW TRANSPLANTATION USING C-MYB (LR-3001) ANTISENSE OLIGODEOXYNUCLEOTIDE TREATED BONE MARROW IN CHRONIC MYELOGENOUS LEUKEMIA IN CHRONIC OR ACCELERATED PHASE

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

Estimated Enrollment:   40
Study Start Date:   June 1993

Detailed Description:

OBJECTIVES: I. Evaluate the ability of c-myb antisense oligodeoxynucleotide to purge bone marrow cells of clonogenic chronic myelogenous leukemia tumor cells and repopulate the bone marrow with normal stem cells in patients treated with high-dose busulfan and cyclophosphamide followed by autologous bone marrow transplantation using marrow treated with c-myb antisense oligodeoxynucleotide. II. Determine the response rate, degree of hematopoietic reconstitution, overall survival, and relapse-free survival of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients.

OUTLINE: Patients undergo bone marrow harvest. The bone marrow is treated with c-myb antisense oligodeoxynucleotide and cryopreserved. A portion of the marrow is cryopreserved untreated in case of engraftment failure. Patients receive oral busulfan every 6 hours on days -7 to -4 for a total of 16 doses. Patients receive cyclophosphamide IV over 1 hour on days -3 and -2. Bone marrow is reinfused on day 0. Patients receive filgrastim (G-CSF) subcutaneously daily beginning on day 0 and continuing until blood counts recover. Patients are followed every 2-3 months for 2 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 18-24 months.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically and cytologically proven chronic myelogenous leukemia Accelerated phase OR Chronic phase No hypocellular marrow (less than 25% cellularity) No patients under age 55 with a HLA-matched sibling donor

PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: 0-1 Hematopoietic: Granulocyte count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 3 times normal Renal: Creatinine less than 2.0 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: Left ventricular ejection fraction normal No significant cardiac disease requiring digoxin, diuretics, antiarrhythmics, or antianginal medications Pulmonary: PFTs normal DLCO normal Other: No persistent infection requiring antibiotics No concurrent organ damage or medical problem that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior interferon therapy Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002592

Locations
United States, Pennsylvania
University of Pennsylvania Cancer Center    
      Philadelphia, Pennsylvania, United States, 19104-4283

Sponsors and Collaborators
University of Pennsylvania
National Cancer Institute (NCI)

Investigators
Study Chair:     Selina M. Luger, MD     University of Pennsylvania    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000063772, UPCC-3492, NCI-H94-0532
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002592
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
relapsing chronic myelogenous leukemia  
chronic phase chronic myelogenous leukemia  
accelerated phase chronic myelogenous leukemia  

Study placed in the following topic categories:
Leukemia
Chronic myelogenous leukemia
Hematologic Diseases
Leukemia, Myeloid, Accelerated Phase
Busulfan
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Cyclophosphamide
Leukemia, Myeloid, Chronic-Phase
Leukemia, Myeloid
Bone Marrow Diseases

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on September 16, 2008




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