Cyclophosphamide and Filgrastim Followed By Stem Cell Transplant in Treating Patients With Chronic or Accelerated Phase Myelogenous Leukemia - Full Text View

Sponsored by:	Masonic Cancer Center, University of Minnesota
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005984

Purpose

RATIONALE: Giving colony-stimulating factors, such as G-CSF, and cyclophosphamide helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy.

PURPOSE: This phase II trial is studying how well cyclophosphamide plus filgrastim followed by stem cell transplant works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia.

Condition	Intervention	Phase
Leukemia	Drug: cyclophosphamide Drug: filgrastim Drug: recombinant interferon alfa Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Radiation Therapy

Drug Information available for: Cyclophosphamide Interferon alfa-2a Filgrastim Interferon alfa-n1 Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming

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

Primary Outcome Measures:

Time to hemopoietic recovery after transplantation [ Designated as safety issue: No ]
Detection of the Philadelphia chromosome or the BCR/ABL gene abnormality in post-transplantation marrow samples [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to initial hospital discharge [ Designated as safety issue: No ]
Peritransplantation toxicity [ Designated as safety issue: Yes ]
Quality of life at various time points [ Designated as safety issue: No ]
Cause of death [ Designated as safety issue: No ]

Study Start Date:

August 2000

Detailed Description:

OBJECTIVES:

Assess the clinical outcomes, survival, and morbidity of patients with chronic or accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and filgrastim (G-CSF) followed by autologous peripheral blood stem cell transplantation.
Determine whether priming with cyclophosphamide and filgrastim (G-CSF) increases the fraction of benign Philadelphia chromosome negative hematopoietic progenitors in peripheral blood stem cells (PBSC) and reduces the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients.

OUTLINE: Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected between days 14-21.

Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1. Patients receive the PBSC transplantation on day 0. Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover. Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression.

Patients are followed at 3 weeks; then at 3, 6, 9, 12, and 18 months; and then annually for 5 years.

PROJECTED ACCRUAL: Not specified

Eligibility

Ages Eligible for Study:	up to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed chronic or accelerated phase chronic myelogenous leukemia (CML)
- Philadelphia chromosome positive OR
- BCR/ABL rearrangement
No blast crisis or post blast crisis
No severe fibrosis defined by bilateral trephine biopsies
No splenomegaly (below umbilicus) that does not respond to chemotherapy and/or radiotherapy
Ineligible or refused to participate in ongoing allogeneic marrow donor transplant protocols

PATIENT CHARACTERISTICS:

Age:

70 and under

Performance status:

Age 65-70 years:
- Karnofsky 80-100%
Under 65 years:
- Karnofsky 90-100%

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Age 65-70 years:
- Creatinine clearance greater than 60 mL/min (if creatinine at least 1.5 mg/dL)
Under 65 years:
- Not specified

Cardiovascular:

Age 65-70 years:
- LVEF at least 45%

Pulmonary:

Age 65-70 years:
- If history of smoking or respiratory symptoms, spirometry and DLCO must be greater then 50% of predicted

Other:

Normal organ function (excluding bone marrow)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

See Disease Characteristics

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005984

Locations

United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

Investigators

Study Chair:

Catherine M. Verfaillie, MD

Masonic Cancer Center, University of Minnesota

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000067972, UMN-MT-9611, UMN-MT-1996-11
Study First Received:	July 5, 2000
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00005984 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

chronic phase chronic myelogenous leukemia
accelerated phase chronic myelogenous leukemia
Philadelphia chromosome positive chronic myelogenous leukemia
childhood chronic myelogenous leukemia

Study placed in the following topic categories:

Philadelphia Chromosome
Interferon-alpha
Interferon Type I, Recombinant
Immunologic Factors
Hematologic Diseases
Interferons
Myeloproliferative Disorders
Cyclophosphamide
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase
Immunosuppressive Agents

Angiogenesis Inhibitors
Antiviral Agents
Leukemia
Leukemia, Myeloid, Accelerated Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Antineoplastic Agents, Alkylating
Chronic Myelogenous Leukemia
Antirheumatic Agents
Bone Marrow Diseases
Interferon Alfa-2a
Alkylating Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Interferon Type I, Recombinant
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Leukemia
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors
Alkylating Agents
Interferon-alpha
Neoplasms by Histologic Type
Hematologic Diseases

Growth Substances
Interferons
Myeloproliferative Disorders
Leukemia, Myeloid
Antiviral Agents
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Myeloablative Agonists
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Interferon Alfa-2a
Bone Marrow Diseases

ClinicalTrials.gov processed this record on May 07, 2009