Status:
COMPLETED
MS-275 and GM-CSF in Treating Patients With Myelodysplastic Syndrome and/or Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphocytic Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Lymphoblastic Leukemia in Remission
Adult Acute Megakaryoblastic Leukemia (M7)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 st...
Detailed Description
PRIMARY OBJECTIVE: I. Determine clinical response in patients with myelodysplastic syndromes and/or relapsed or refractory acute myeloid leukemia or acute lymphocytic leukemia treated with MS-275 in ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00462605
Start Date
April 1 2007
End Date
March 1 2011
Last Update
July 18 2017
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287-8936