NCT00030355

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/II trial to study the effectiveness of homoharringtonine in treating patients who have refractory acute promyelocytic leukemia.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2002

Completed
12 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

March 22, 2013

Status Verified

September 1, 2007

First QC Date

February 14, 2002

Last Update Submit

March 21, 2013

Conditions

Leukemia

Keywords

recurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiaadult acute promyelocytic leukemia (M3)childhood acute promyelocytic leukemia (M3)adult acute myeloid leukemia with t(15;17)(q22;q12)

Outcome Measures

Primary Outcomes (2)

  • Safety by physical examinations, vital signs, laboratory studies (routine hematology, clinical chemistry, pharmacokinetics, urinalysis, chest x-ray, and EKG), and solicited and unsolicited adverse events

  • Efficacy by response to treatment

Secondary Outcomes (5)

  • Pharmacokinetics

  • Duration of treatment response

  • Survival

  • Induction mortality

  • Hospitalizations

Interventions

homoharringtonineDRUG
chemotherapyPROCEDURE

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of acute promyelocytic leukemia confirmed morphologically and by t(15;17) translocation or molecular polymerase chain reaction * Refractory to tretinoin, anthracyclines, and arsenic-based therapy (including arsenic trioxide) and for which no other alternative therapy of higher priority is appropriate PATIENT CHARACTERISTICS: Age: * 12 and over Performance status: * Zubrod 0-3 Life expectancy: * More than 4 weeks Hematopoietic: * See Disease Characteristics Hepatic: * Bilirubin no greater than 2.0 mg/dL * ALT no greater than 3 times upper limit of normal Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No New York Heart Association class III or IV heart disease * No active ischemia * No other uncontrolled cardiac condition (e.g., angina pectoris, cardiac arrhythmia, hypertension, or congestive heart failure) * No myocardial infarction within the past 12 weeks Other: * No other concurrent illness that would preclude study * No other active malignancy * No uncontrolled active infection * No clinically significant screening serum chemistry results unless attributed to acute promyelocytic leukemia * No medical or psychiatric condition that would preclude informed consent or study therapy * HIV negative * HTLV-I and HTLV-II negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior or concurrent leukapheresis allowed Chemotherapy: * See Disease Characteristics * At least 15 days since prior systemic chemotherapy unless leukemia progression necessitates early therapy * No other concurrent systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * Recovered from prior therapy * At least 15 days since other prior antileukemic therapy unless leukemia progression necessitates early therapy * No other concurrent antileukemic therapy

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

Sponsors & Collaborators

Study Sites (1)

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, AcuteLeukemia, Promyelocytic, Acute

Interventions

HomoharringtonineDrug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

HarringtoninesAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 4 or More RingsTherapeutics

Study Officials

  • Jorge Cortes, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 14, 2002

First Posted

January 27, 2003

Last Updated

March 22, 2013

Record last verified: 2007-09

Locations

US(1)