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LeukemiaPhase 1NCT00015925

MS-275 in Treating Patients With Hematologic Cancer

A Phase 1 study testing entinostat in people with Leukemia and Multiple Myeloma and Plasma Cell Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
entinostat
How many people
Not given
Where
2 sitesUnited States
Study dates
Feb 2001to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

Other trials in United States

About this study

Official title: Phase I Clinical-Labratory Study of the Histone Deacetylase (HDA) Inhibitor MS-275 in Adults With Refractory and Relapsed Hematologic Malignancies

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.

Read the detailed description

OBJECTIVES:

  • Determine the toxic effects and pharmacokinetics of MS-275 in patients with poor-risk hematologic malignancy.
  • Determine whether this drug induces changes in hematologic differentiation, in terms of changes in morphology, cell surface marker expression, and acetylation status, in these patients.
  • Determine whether this drug induces clinical response in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral MS-275 on days 1, 8, 15, and 22. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of MS-275 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for this study.

Being tested
entinostat
Keywords
refractory multiple myeloma, recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, untreated adult acute lymphoblastic leukemia, untreated adult acute myeloid leukemia, adult acute promyelocytic leukemia (M3), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, chronic myelomonocytic leukemia, secondary acute myeloid leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22)
Medical subject headings
Leukemia, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Chronic-Phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • entinostatDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00015925
Sponsor's protocol ID
CDR0000068574, J0253
Other IDs
U01CA069854, P30CA006973, JHOC-J0253, MSGCC-0050, NCI-2791
Status last verified
Mar 2010
First submitted
6 May 2001
Last updated
10 Mar 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing entinostat in people with Leukemia and Multiple Myeloma and Plasma Cell Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2010.

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