Overview

MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia

Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
All
Summary
This phase II trial is studying how well giving MS-275 together with GM-CSF works in treating patients with myelodysplastic syndrome and/or relapsed or refractory acute myeloid leukemia. MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving MS-275 together with GM-CSF may be an effective treatment for myelodysplastic syndrome and acute myeloid leukemia
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johns Hopkins University
National Cancer Institute (NCI)
Treatments:
Entinostat
Histone Deacetylase Inhibitors
Sargramostim
Criteria
Inclusion Criteria:

- Diagnosis of 1 of the following diseases by bone marrow aspiration and/or biopsy:

- Myelodysplastic syndromes (MDS) meeting the following criteria:

- Must have 1 of the following subtypes:

- Refractory anemia (RA) (no RA with 5q-syndrome),

- RA with ringed sideroblasts or

- Refractory cytopenia with multilineage dysplasia

- Myelodysplastic syndromes (MDS) meeting the following criteria:

Must have 1 of the following subtypes:

- Refractory cytopenia with multilineage dysplasia and ringed sideroblasts,

- RA with excess blasts (RAEB)-1, RAEB-2,

- Myelodysplastic syndromes, unclassified or

- Chronic myelomonocytic leukemia

- International Prognostic Scoring System score of intermediate-2 or high-risk

- Acute myeloid leukemia (AML) meeting 1 of the following criteria:

- Relapsed or refractory AML, including any of the following subtypes:

- * AML with recurrent cytogenetic abnormalities (i.e., AML with 11q23 [MLL]
abnormalities)

- AML with multilineage dysplasia

- AML that is therapy-related

- AML, not otherwise categorized (M0 [minimally differentiated], M1 [without
maturation], M2 [with maturation], M4 [myelomonocytic leukemia], M5
[monoblastic/monocytic leukemia], M6 [erythroid leukemia], and M7 [megakaryoblastic
leukemia])

- Untreated AML

- Newly diagnosed patients are eligible provided they do not qualify for potentially
curative intensive chemotherapeutic regimens

- Acute lymphocytic leukemia (ALL) meeting 1 of the following criteria:

- Relapsed or refractory ALL

- Patients with any measurable residual disease are eligible, including cytogenetic
abnormalities

- Untreated ALL

- Newly diagnosed patients are eligible provided they do not qualify for potentially
curative intensive chemotherapeutic regimens, including any of the following:

- Patients who have refused chemotherapy for untreated ALL

- Patients who are deemed to be poor candidates medically for ALL induction chemotherapy

- Relatively stable bone marrow function for > 7 days prior to study entry

- WBC count that has not doubled within the past 7 days

- WBC =<10,000/mm³

- No uncontrolled peripheral leukemia (i.e., blast count > 30,000/mm³)

- No active CNS disease

- Lumbar puncture with negative cytology required for patients with clinical symptoms of
active CNS disease

- Not a candidate for a potentially curative allogeneic stem cell transplantation
OR considered a poor candidate for such a procedure due to age, medical
comorbidities, or lack of a suitable donor

- Hemoglobin >= 8 g/dL (transfusions allowed)

- Creatinine =< 2.0 mg/dL

- Bilirubin =< 1.6 mg/dL (unless secondary to hemolysis)

- AST or ALT =< 3 times upper limit of normal (unless disease-related)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No untreated or progressive infections

- No history of intolerance to sargramostim (GM-CSF)

- Recovered from all treatment-related toxicities

- More than 2 weeks since prior therapy for AML, ALL, or MDS, including
chemotherapy, hematopoietic growth factors, or biologic therapy such as
monoclonal antibodies

- Concurrent hydroxyurea allowed during course 1 for control of leukocytosis if WBC
> 30,000/mm³

- ECOG performance status 0-2