MS-275 in Treating Patients With Hematologic Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Entinostat

Criteria

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