Decitabine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Brief Summary

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This phase I trial is studying the side effects and best dose of decitabine in treating patients with myelodysplastic syndromes or acute myeloid leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

Detailed Description

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OBJECTIVES:

I. Determine the maximum tolerated dose of decitabine in patients with high-risk myelodysplastic syndromes or acute myeloid leukemia.

II. Determine the minimum effective dose of this drug that produces demethylation of DNA with tolerable toxicity in these patients.

III. Determine the minimum effective dose of this drug that augments in vitro responses to retinoids.

IV. Determine the pharmacokinetics of this drug in these patients. V. Determine the clinical response rate of patients treated with this drug.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive decitabine IV over 3 hours twice daily OR IV over 1 hour once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study within 18 months.

Conditions

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Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative de Novo Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Previously Treated Myelodysplastic Syndromes Recurrent Adult Acute Myeloid Leukemia Secondary Acute Myeloid Leukemia Secondary Myelodysplastic Syndromes Untreated Adult Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (decitabine)

Patients receive decitabine IV over 3 hours twice daily OR IV over 1 hour once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of decitabine until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Group Type EXPERIMENTAL

decitabine

Intervention Type DRUG

Given IV

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

pharmacological study

Intervention Type OTHER

Correlative studies

Interventions

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decitabine

Given IV

Intervention Type DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

pharmacological study

Correlative studies

Intervention Type OTHER

Other Intervention Names

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5-aza-dCyd 5AZA DAC pharmacological studies

Eligibility Criteria

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Inclusion Criteria

* One of the following diagnoses:

* High-risk myelodysplastic syndromes (MDS)
* Acute myeloid leukemia (AML)

* De novo, secondary, or relapsed disease
* Any number of prior regimens for primary or relapsed disease
* Ineligible for or refuses aggressive management
* Measurable disease, defined as:

* More than 5% blasts in bone marrow of patients with MDS
* More than 30% blasts in bone marrow of patients with AML
* Involvement of cerebrospinal fluid allowed
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* See Disease Characteristics
* Bilirubin no greater than 1.25 times upper limit of normal (ULN)
* AST and/or ALT no greater than 1.25 times ULN
* Creatinine less than 1.7 mg/dL
* Creatinine clearance at least 60 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* No ongoing or active infection
* No other uncontrolled illness that would preclude study participation
* No psychiatric illness or social situation that would preclude study compliance
* No prior allergic reactions to compounds of similar chemical or biological composition to decitabine
* No other active malignancy
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* At least 4 weeks since prior biologic therapy (e.g., interferon, filgrastim \[G-CSF\], sargramostim \[GM-CSF\], thrombopoietin, or epoetin alfa)
* No concurrent hematopoietic growth factors (GM-CSF, thrombopoietin, or epoetin alfa)
* No concurrent prophylactic G-CSF
* Prior intrathecal cytarabine allowed for patients with cerebrospinal fluid involvement
* At least 4 weeks since prior chemotherapy (except low-dose chemotherapy administered to maintain WBC counts) (6 weeks for nitrosoureas or mitomycin) and recovered
* At least 24 hours since prior hydroxyurea
* Concurrent intrathecal cytarabine allowed for patients with cerebrospinal fluid involvement
* No prior radiotherapy greater than 3,000 cGy to marrow-producing areas
* At least 4 weeks since prior radiotherapy and recovered
* Prior investigational therapy allowed
* No other concurrent investigational agents
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent anticancer therapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Minden

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital Phase 2 Consortium

Locations

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Princess Margaret Hospital Phase 2 Consortium

Toronto, Ontario, Canada

Site Status

Countries

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Canada