OBJECTIVES:

Primary

• Determine the efficacy of CC-5013, in terms of hematological improvement, in patients with red blood cell transfusion-dependent low- or intermediate-risk myelodysplastic syndromes and a del(5)(q31q33) cytogenetic abnormality.

Secondary

• Determine the safety of this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral CC-5013 on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of low- or intermediate-risk myelodysplastic syndromes (MDS) associated with a del(5)(q31q33) cytogenetic abnormality

  • Cytogenetic abnormality may be an isolated cytogenetic finding (the 5q- syndrome) OR may be associated with other cytogenetic abnormalities
• Red blood cell (RBC) transfusion-dependent anemia defined as having received at least 2 units of RBCs within the past 8 weeks

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 500/mm^3
• Platelet count at least 50,000/mm^3
• No clinically significant anemia due to iron, B_12, or folate deficiency, autoimmune or hereditary hemolysis, or gastrointestinal bleeding

• If marrow aspirate not evaluable for storage iron, the following criteria must be met:

  • Transferrin saturation at least 20%
  • Serum ferritin at least 50 ng/mL

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• AST and ALT no greater than 3.0 times upper limit of normal

Renal

• Creatinine no greater than 2.5 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior grade 3 or greater allergic reaction or hypersensitivity to thalidomide
• No prior grade 3 or greater rash or any desquamation (blistering) from thalidomide
• No other serious medical condition, laboratory abnormality, or psychiatric illness that would preclude study participation or giving informed consent or confound study results
• No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior CC-5013
• More than 7 days since prior hematopoietic growth factors
• No concurrent epoetin alfa for MDS

Chemotherapy

• More than 28 days since prior experimental or standard chemotherapy for MDS
• No concurrent chemotherapy for MDS

Endocrine therapy

• More than 28 days since prior chronic use (greater than 2 weeks in duration) of more than physiologic doses of corticosteroids
• No concurrent androgens for MDS

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 28 days since prior experimental or standard immunosuppressive or cytoprotective agents for MDS
• More than 28 days since other prior experimental or standard drugs or therapy for MDS
• No other concurrent investigational agents for MDS