S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome - Full Text View

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 2


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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: Myelodysplastic Syndromes

Drug Information available for: Cyclosporine Cyclosporin Antilymphocyte Serum

Genetic and Rare Diseases Information Center resources: Myelodysplastic Syndromes Sideroblastic Anemia Pyridoxine-refractory Autosomal Recessive

U.S. FDA Resources

Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:

total response [ Time Frame: after induction therapy is completed ] [ Designated as safety issue: No ]


Estimated Enrollment:	130
Study Start Date:	August 2001
Study Completion Date:	January 2007
Primary Completion Date:	July 2003 (Final data collection date for primary outcome measure)

Intervention Details:

3.5 mg/kg/d IV over 12 hrs day 1

3 mg/kg bid days 5-94 then taper to 0 at day 124 PO

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Southwest Oncology Group
ClinicalTrials.gov Identifier:	NCT00016419 History of Changes
Other Study ID Numbers:	CDR0000068631, S0020, U10CA032102
Study First Received:	May 6, 2001
Last Updated:	January 12, 2012
Health Authority:	United States: Federal Government

Keywords provided by Southwest Oncology Group:


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:


Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases Hematologic Diseases Neoplasms Precancerous Conditions	Antilymphocyte Serum Immunologic Factors Immunosuppressive Agents Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015