RAD001(Everolimus) in Treating Patients With Myelodysplastic Syndromes

• Status: Terminated
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: RAD001(Everolimus) may stop the growth of cancer cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the cancer.

PURPOSE: This phase II trial is studying how well RAD001(everolimus) works in treating patients with myelodysplastic syndromes.

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

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

• Low or intermediate-1 risk myelodysplastic syndromes by International Prognostic Scoring System (IPSS) criteria

• IPSS score < 1.5

• Requiring transfusion of 2 units of red blood cells at least once a month (four weeks prior to accrual on study)

• High levels of endogenous epoetin alfa (i.e., > 200 mU/mL)

• Unlikely to respond to epoetin alfa, or has a documented clinical non-response to epoetin alfa (at a dose of ≥ 40,000 U weekly) or darbepoetin alfa (at a dose > 200 mcg every other week) (i.e., < 2 g/dL increase in hemoglobin and no decrease in transfusion requirements after at least 4 weeks of treatment)

• No chronic myelomonocytic leukemia

PATIENT CHARACTERISTICS:

• ECOG Performance Status of 0-2

• Liver enzymes (AST and ALT) and total bilirubin ≤ 2 times upper limit of normal

• Serum creatinine ≤ 2 times upper limits of normal

• No clinically significant anemia due to iron, B12, or folate deficiencies; autoimmune or hereditary hemolysis; or gastrointestinal bleeding

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other serious or poorly controlled medical condition that could be exacerbated by or complicate compliance with study therapy

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior treatment (including growth factors)

• No chronic use (> 2 weeks) of physiologic doses of a corticosteroid agent (dose equivalent to > 10 mg/day of prednisone) within 28 days of the first day of study drug

• No concurrent use of another investigational agent

• No concurrent therapy with any cytotoxic drugs, steroids, or growth factors