NCT00016419

S0020 Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00016419

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

A Phase II Study of Anti-Thymocyte Globulin and Cyclosporine for Patients With Myelodysplastic Syndrome (MDS)

Summary

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.

Eligibility

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

Disease(s) and\or Condition(s)

Leukemia

Myelodysplastic Syndromes

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: anti-thymocyte globulin
- Description: 3.5 mg/kg/d IV over 12 hrs day 1
- Arm Group Labels:
- Type: DRUG
- Name: cyclosporine
- Description: 3 mg/kg bid days 5-94 then taper to 0 at day 124 PO
- Arm Group Labels:

Sponsor

SWOG Cancer Research Network