Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00016419

Purpose

RATIONALE: Immunosuppressive therapy may improve bone marrow abnormalities and may be an effective treatment for myelodysplastic syndrome.

PURPOSE: Phase II trial to study the effectiveness of antithymocyte globulin plus cyclosporine in treating patients who have myelodysplastic syndrome.

Condition	Intervention	Phase
Leukemia Myelodysplastic Syndromes	Biological: anti-thymocyte globulin Drug: cyclosporine	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS)

Resource links provided by NLM:

MedlinePlus related topics: Anemia Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

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

Study Start Date:

August 2001

Detailed Description:

OBJECTIVES:

Determine the response in patients with myelodysplastic syndromes treated with anti-thymocyte globulin and cyclosporine.
Determine the frequency and severity of toxic effects of this regimen in these patients.
Assess the correlation between response to treatment and the in vitro assessment of T-lymphocyte subsets in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to myelodysplastic syndrome subclassification (refractory anemia [RA] vs RA with ringed sideroblasts vs RA with excess blasts).

Patients receive induction therapy comprising anti-thymocyte globulin IV over 6-12 hours on days 1-4 and oral cyclosporine twice daily on days 5-94 followed by a taper until day 124. Patients who relapse after a response of at least 60 days may receive reinduction therapy comprising oral cyclosporine twice daily on days 1-90 followed by a taper until day 120. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed monthly for 6 months, every 2 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 130 patients (53 with refractory anemia [RA], 33 with RA with ringed sideroblasts, and 44 with RA with excess blasts) will be accrued for this study within 14-22 months.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Morphologically confirmed myelodysplastic syndromes (MDS)
- Refractory anemia (RA)
- RA with ringed sideroblasts
- RA with excess blasts
Low, intermediate-1, or intermediate-2 risk by International Prognostic Scoring System criteria
MDS secondary to prior chemotherapy and/or radiotherapy for other malignant disorders allowed
Must have received prior transfusions of at least 4 units of red blood cells for anemia within the past 60 days
Must be concurrently registered on SWOG-S9910 and SWOG-9007
Ineligible for or refused participation in SWOG-S9920 (HLA-identical sibling peripheral blood stem cell transplantation)

PATIENT CHARACTERISTICS:

Age:

15 and over

Performance status:

Zubrod 0-2

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
HIV negative
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

See Disease Characteristics
Prior cytokines (e.g., interferon or interleukin), colony-stimulating factors, or epoetin alfa allowed
No prior bone marrow or stem cell transplantation
No concurrent growth factors (including epoetin alfa) except filgrastim (G-CSF) or sargramostim (GM-CSF) for neutropenia

Chemotherapy:

See Disease Characteristics
No prior remission induction chemotherapy for MDS
Prior hydroxyurea allowed

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics

Surgery:

Not specified

Other:

Prior amifostine allowed
No calcium-channel blockers (diltiazem, nicardipine, or verapamil), antifungals (fluconazole, itraconazole, or ketoconazole), antibiotics (clarithromycin or erythromycin), or other drugs (bromocriptine or danazol) that would increase cyclosporine concentrations for 48 hours before, during, and for 48 hours after cyclosporine
No antibiotics (nafcillin or rifampin) or anticonvulsants (carbamazepine, phenobarbital, or phenytoin) that would decrease cyclosporine concentrations for 14 days before and during cyclosporine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016419

Show 94 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles A. Schiffer, MD

Barbara Ann Karmanos Cancer Institute

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:	CDR0000068631, SWOG-S0020
Study First Received:	May 6, 2001
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00016419 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

refractory anemia
refractory anemia with ringed sideroblasts
refractory anemia with excess blasts

de novo myelodysplastic syndromes
secondary myelodysplastic syndromes
childhood myelodysplastic syndromes

Additional relevant MeSH terms:

Anti-Infective Agents
Cyclosporine
Precancerous Conditions
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclosporins
Leukemia
Preleukemia
Pathologic Processes
Syndrome
Antifungal Agents
Therapeutic Uses

Dermatologic Agents
Disease
Neoplasms by Histologic Type
Hematologic Diseases
Myelodysplastic Syndromes
Enzyme Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Antilymphocyte Serum
Neoplasms
Bone Marrow Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 27, 2009