NCT00015925

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

March 10, 2010

Status Verified

March 1, 2010

First QC Date

May 6, 2001

Last Update Submit

March 9, 2010

Conditions

LeukemiaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Diseases

Keywords

refractory multiple myelomarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiarelapsing chronic myelogenous leukemiachronic phase chronic myelogenous leukemiaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiauntreated adult acute lymphoblastic leukemiauntreated adult acute myeloid leukemiaadult acute promyelocytic leukemia (M3)refractory anemia with excess blastsrefractory anemia with excess blasts in transformationchronic myelomonocytic leukemiasecondary acute myeloid leukemiade novo myelodysplastic syndromespreviously treated myelodysplastic syndromesatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiableadult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with t(15;17)(q22;q12)

Interventions

entinostatDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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 therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

LeukemiaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, Accelerated PhaseBlast CrisisLeukemia, Promyelocytic, AcuteAnemia, Refractory, with Excess of BlastsLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersCongenital Abnormalities

Interventions

entinostat

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesBone Marrow DiseasesLeukemia, MyeloidLeukemia, LymphoidLymphatic DiseasesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesAnemia, RefractoryAnemiaCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Judith E. Karp, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2001

First Posted

January 27, 2003

Study Start

February 1, 2001

Last Updated

March 10, 2010

Record last verified: 2010-03

Locations

US(2)