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