Status:
TERMINATED
RAD001(Everolimus) in Treating Patients With Myelodysplastic Syndromes
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 stu...
Detailed Description
OBJECTIVES: Primary * Determine the clinical activity (improvement in erythroid response and/or improvement in other cytopenias, bone marrow morphology/cytogenetics) of RAD001(everolimus) in patient...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00809185
Start Date
November 1 2005
End Date
March 1 2009
Last Update
March 7 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195