Jason Gotlib
Azacitidine With or Without MS-275 in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
RATIONALE: 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. MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with MS-275 may kill more cancer cells. PURPOSE: This randomized phase II trial is studying azacitidine and MS-275 to see how well they work compared to azacitidine alone in treating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: MS-275
- Drug: azacitidine
- Procedure: enzyme inhibitor therapy
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
DISEASE CHARACTERISTICS:
- Bone marrow aspirate and/or biopsy-confirmed diagnosis of 1 of the following:
. Myelodysplastic syndromes (MDS)
^ Any International Prognostic Score (IPSS) eligible
~ Patients with low or intermediate-1 IPSS must have platelet count < 50,000/mm? and/or absolute neutrophil count < 500/mm?
. Chronic myelomonocytic leukemia (dysplastic subtype)
^ WBC < 12,000/mm? (measured twice within the past 4 weeks, 2 weeks apart)
. Acute myeloid leukemia with multilineage dysplasia (AML-TLD)
^ Formerly diagnosed refractory anemia with excess blasts in transformation by FAB criteria allowed
^ AML-TLD by WHO criteria allowed in patients with no history of antecedent hematologic disorder
^ WBC <= 30,000/mm? (measured twice within the past 4 weeks, 2 weeks apart)
~ WBC that has doubled over 4 weeks AND > 20,000/mm? is not eligible
- SWOG patients must be enrolled in research study trial SWOG-9007
- No therapy-induced MDS or AML-TLD
- No clinical evidence of CNS or pulmonary leukostasis or disseminated intravascular coagulation
- No clinical evidence of CNS leukemia
PATIENT CHARACTERISTICS:
- See Disease Characteristics
- ECOG performance status 0-2
- Life expectancy >= 6 months
- Creatinine < 2.0 mg/dL
- Bilirubin normal (unless due to intramedullary or extramedullary hemolysis, or Gilbert's syndrome)
- AST and ALT <= 2.5 times upper limit of normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infections
- No advanced malignant hepatic tumors
- No other serious or uncontrolled medical conditions
- No known hypersensitivity to azacitidine or mannitol
PRIOR CONCURRENT THERAPY:
- Recovered from prior therapy
- No prior azacitidine, decitabine or MS-275
- No prior induction chemotherapy for AML or stem cell transplantation
- No hematopoietic growth factors within 3 weeks prior to study entry
- No other concurrent investigational or commercial agents or therapies for the malignancy
- No concurrent valproic acid, epoetin alfa, or darbepoetin alfa
- No filgrastim (G-CSF) or pegfilgrastim during days 1-10 of each treatment course
Key Exclusion Criteria:
Additional Study Details
Official Title:
A Randomized Phase II Trial of Azacitidine With or Without the Histone Deacetylase Inhibitor MS-275 for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (Dysplastic Type), and Acute Myeloid Leukemia With Multilineage DysplasiaAnticipated start date:
11/7/2006Lead Sponsor:
Eastern Cooperative Oncology GroupCollaborator(s):
- National Cancer Institute (NCI)
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- To estimate the overall response rate (complete, partial, and hematologic improvement-major by IWG criteria) in response to Azacitidine and MS-275
- To estimate the major response rate (complete and partial responses byIWG criteria)5 to a 10-day regimen of Azacitidine and to the same reginmen of Azacitidine in combination with MS-275 administered orally on days 3 and 10 of each cycle in patients with MDS, CMMoL (dysplastic) and AML-TLD
Secondary Outcomes:
- To evaluate the toxicity of Azacitidine and MS-275 in this patient population
- To identify changes in gene promoter methlation and gene expression which may be associated with repsonse to Azacitidine and MS-275
- To identify other molecular mechanisms (such as DNA damage) which may be associated with response to Azacitidine and MS-275
Total Number to be Enrolled:
148Total Number to be Enrolled at Stanford:
10More Information
Secondary ID(s):
- 97470
- ECOG-E1905
- NCT00313586
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/26/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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