Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. Lenalidomide may also stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also cause cancer cells to look more like normal cells, and to grow and spread more slowly. Giving lenalidomide together with azacitidine may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide and azacitidine in treating patients with advanced myelodysplastic syndromes.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mikkael Sekeres MD
• Collaborator: National Cancer Institute (NCI)
• Treatments: Azacitidine; Lenalidomide; Thalidomide

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of myelodysplastic syndromes (MDS) meeting one of the following criteria:

• French-American-British histological classification criteria

• Refractory anemia with excess blasts (RAEB), defined as 5-19% myeloblasts in the bone marrow

• Patients with 20% blasts are considered to have acute myeloid leukemia (per WHO classification system) and are therefore excluded in this study

• Chronic myelomonocytic leukemia (CMML), defined as 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood

• WHO histological classification criteria

• RAEB-1, defined as 5-9% myeloblasts in the bone marrow

• RAEB-2, defined as 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood

• CMML-2, defined as 10-19% myeloblasts in the bone marrow and/or 5-19% blasts in the blood

• International Prognostic Scoring System (IPSS) score of intermediate 2 (1.5-2.0 points based on karyotype, cytopenias, and bone marrow blast percentage) or high (≥ 2.5 points), in the setting of ≥ 5% myeloblasts

• Considered ineligible for bone marrow transplantation as first-line therapy

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 3 months

• ECOG performance status 0-2

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective double-method contraception for 4 weeks before, during, and for 4 weeks after completion of study treatment

• No serious medical condition, laboratory abnormality, or psychiatric illness that, in the opinion of the treating physician, would preclude study participation or preclude giving informed consent

• No preexisting neurotoxicity or neuropathy ≥ grade 2

• No rash or prior hypersensitivity or allergic reaction ≥ grade 3 to thalidomide

• Creatinine ≤ 2.0 mg/dL

• AST and ALT ≤ 2.0 times upper limit of normal

• Bilirubin ≤ 2 mg/dL

• Platelet count ≥ 50,000/mm^3

• Absolute neutrophil count ≥ 500/mm^3

• No other malignancy within the past 3 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer

• No history of thromboembolic event or other condition requiring use of anticoagulation with warfarin or low molecular-weight heparin

• No known or suspected hypersensitivity to azacitidine or mannitol

PRIOR CONCURRENT THERAPY:

• More than 28 days since prior and no other concurrent investigational agents for MDS

• More than 28 days since prior approved therapy for MDS

• More than 14 days since prior growth factors

• More than 28 days since prior and no concurrent supraphysiologic doses (equivalent to > 10 mg/day of prednisone) of corticosteroids

• More than 12 months since prior radiotherapy, chemotherapy, or cytotoxic therapy for treatment of conditions other than MDS

• No prior lenalidomide or azacitidine

• No prior stem cell or bone marrow transplantation

• No concurrent androgens, epoetin alfa, or chemotherapy for MDS