Clinical trial · Interventional
MS-275 in Treating Patients With Hematologic Cancer
Phase I Clinical-Labratory Study of the Histone Deacetylase (HDA) Inhibitor MS-275 in Adults With Refractory and Relapsed Hematologic Malignancies
NCT00015925CI-TRIAL-00003251completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of MS-275 in treating patients who have hematologic cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| entinostat | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* One of the following histologically confirmed diagnoses:
* Acute myeloid leukemia (AML)
* Newly diagnosed de novo AML in patients over 60 years old with the following poor-risk features:
* Antecedent hematologic disorder
* Complex karyotype or other adverse cytogenetics
* Stem cell immunophenotype
* AML arising from myelodysplastic syndromes (MDS)
* Secondary AML
* Relapsed or refractory AML, including primary induction failure
* MDS
* Poor-risk, defined as the following:
* International Performance Score at least 1.5
* More than 10% marrow blasts
* Cytopenias in at least 2 lineages
* Refractory anemia with excess blasts (RAEB)
* RAEB in transformation
* Chronic myelomonocytic leukemia
* Acute lymphoblastic leukemia (ALL)
* Newly diagnosed de novo ALL in patients over 60 years old with the following poor-risk features:
* Complex karyotype or other adverse cytogenetics
* Mixed lineage immunophenotype
* Relapsed or refractory ALL, including primary induction failure
* Chronic myelogenous leukemia (CML)
* CML in accelerated phase or blast crisis
* Interferon-refractory CML in chronic phase
* Multiple myeloma (MM)
* Relapsed or refractory, including prior autologous stem cell transplantation
* Acute promyelocytic leukemia
* Prior treatment with tretinoin
* Ineligible for arsenic trioxide
* No evidence of active coagulopathy
* Low-risk for developing clinically significant coagulopathy during study
* Low tumor burden by marrow aspiration at time of relapse
* No prior coagulation-related sequelae (deep vein thrombosis, pulmonary embolism, or CNS thrombosis or bleed)
* Failure after primary induction therapy or relapse after complete remission allowed if patient received no more than 3 courses of prior induction/reinduction therapy
* Not eligible for curative stem cell transplantation
* No hyperleukocytosis with at least 50,000/mm\^3 leukemic blasts
* No active CNS leukemia
* No plasma cell leukemia
* No amyloidosis resulting in major organ dysfunction
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
* No disseminated intravascular coagulation
* No hyperviscosity
Hepatic:
* AST/ALT no greater than 2 times normal
* Alkaline phosphatase no greater than 2 times normal
* Bilirubin no greater than 1.5 times normal
Renal:
* Creatinine no greater than 1.5 times normal
* No uncorrected hypercalcemia
Cardiovascular:
* See Disease Characteristics
* LVEF at least 45% by MUGA or echocardiogram
* No intrinsic impaired cardiac function, including any of the following:
* Myocardial infarction within the past 3 months
* Prior severe coronary artery disease
* Cardiomyopathy
* Congestive heart failure
Other:
* No active uncontrolled infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
* At least 1 week since prior growth factors (epoetin alfa, filgrastim \[G-CSF\], sargramostim \[GM-CSF\], interleukin \[IL\]-3, or IL-11)
* At least 4 weeks since prior autologous stem cell transplantation
* No prior allogeneic stem cell transplantation
* No concurrent immunotherapy
Chemotherapy:
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy and recovered
* At least 24 hours since prior hydroxyurea or mercaptopurine for prevention of leukostasis
* No concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* At least 2 weeks since prior emergency radiotherapy to large soft tissue or lytic bony lesions for MM
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* At least 24 hours since other prior noncytotoxic agents for prevention of leukostasis
* No other concurrent antitumor therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.