Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome - Full Text View

Sponsors and Collaborators:	Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)
Information provided by:	Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:	NCT00024050

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy.

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

Condition	Intervention	Phase
Leukemia Myelodysplastic Syndromes	Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi

Resource links provided by NLM:

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

Drug Information available for: Cyclophosphamide Busulfan Methotrexate Cyclosporine Cyclosporin

U.S. FDA Resources

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

Study Start Date:	February 2001
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the non-relapse toxicity and mortality on day 100 and at 1 year after transplantation in patients with low or intermediate-risk myelodysplastic syndrome treated with busulfan, cyclophosphamide, and allogeneic peripheral blood stem cell transplantation.
Determine the incidence of donor stem cell engraftment and relapse-free survival in these patients treated with this regimen.
Determine the incidence and severity of acute and chronic graft-versus-host disease and invasive fungal infections in these patients treated with this regimen.
Determine the incidence of relapse in these patients treated with this regimen.

OUTLINE: Peripheral blood stem cells (PBSC) or bone marrow are harvested from a related or unrelated compatible donor. PBSC are selected for CD34+ cells.

Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2.

Allogeneic PBSC or bone marrow is infused on day 0.

As graft-versus-host disease prophylaxis, patients receive cyclosporine IV beginning on day -1 and continuing orally twice daily (if feasible) until day 51 followed by a taper. Patients also receive methotrexate IV on days

1, 3, 6, and 11.

Patients are followed through day 100, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of low or intermediate-risk myelodysplastic syndrome
- Refractory anemia (RA)
- RA with ringed sideroblasts
No advanced myelodysplastic syndrome (i.e., at least 5% blasts in the marrow, more than 1% blasts in the peripheral blood, or blasts in the cerebrospinal fluid)
No poor-risk cytogenetics (i.e., abnormalities of chromosome 7 or complex abnormalities)
HLA-A, B, C, DRB1, and DQB1 compatible related or unrelated donor available
- Mismatch for a single HLA-A, B, C, DRB1, or DQB1 allele allowed

PATIENT CHARACTERISTICS:

Age:

65 and under

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

AST no greater than 2 times normal

Renal:

Creatinine no greater than 2 times upper limit of normal
Creatinine clearance at least 50%

Cardiovascular:

No cardiac insufficiency requiring treatment
No symptomatic coronary artery disease

Pulmonary:

No severe hypoxemia (pO2 less than 70 mm Hg with DLCO less than 70% predicted)
No mild hypoxemia (pO2 less than 80 mm Hg with DLCO less than 60% predicted)

Other:

No other disease that would limit life expectancy
HIV negative
Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

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: NCT00024050

Locations

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Study Chair:

H. Joachim Deeg, MD

Fred Hutchinson Cancer Research Center

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:	CDR0000068887, FHCRC-1536.00, NCI-G01-2009
Study First Received:	September 13, 2001
Last Updated:	July 2, 2009
ClinicalTrials.gov Identifier:	NCT00024050 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:

refractory anemia
refractory anemia with ringed sideroblasts
de novo myelodysplastic syndromes

previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
childhood myelodysplastic syndromes

Study placed in the following topic categories:

Antimetabolites
Anti-Infective Agents
Cyclosporine
Precancerous Conditions
Immunologic Factors
Folate
Cyclophosphamide
Cyclosporins
Vitamin B9
Refractory Anemia
Leukemia
Preleukemia
Anemia, Refractory
Antifungal Agents

Neoplasm Metastasis
Methotrexate
Alkylating Agents
Hematologic Diseases
Myelodysplastic Syndromes
Anemia
Folinic Acid
Folic Acid Antagonists
Immunosuppressive Agents
Folic Acid
Busulfan
Antineoplastic Agents, Alkylating
Bone Marrow Diseases
Antirheumatic Agents

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Cyclosporine
Precancerous Conditions
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Cyclophosphamide
Cyclosporins
Leukemia
Preleukemia
Pathologic Processes

Antifungal Agents
Syndrome
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Disease
Neoplasms by Histologic Type
Hematologic Diseases
Myelodysplastic Syndromes
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal

ClinicalTrials.gov processed this record on September 02, 2009