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WithdrawnNCT00030355Updated Mar 22, 2013

Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia

A Phase 1/2 interventional study of homoharringtonine and chemotherapy in Leukemia, sponsored by National Cancer Institute (NCI). Withdrawn at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2013-03-22.

Sponsored by National Cancer Institute (NCI) · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Ages
12 Years and older
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

  • Determine the safety of salvage therapy comprising homoharringtonine in patients with refractory acute promyelocytic leukemia.
  • Determine the antileukemic efficacy of this drug in these patients.

OUTLINE: Patients receive remission induction therapy comprising homoharringtonine (HH) IV continuously on days 1-14. Courses repeat every 4 weeks in the absence of unacceptable toxicity until a complete remission (CR) is achieved or the patient fails to respond after 3 courses.

Patients who achieve a CR during induction therapy receive maintenance therapy comprising HH IV continuously on days 1-7. Maintenance treatment repeats every 4 weeks for a total of 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study.

02

Conditions studied

  • Leukemia

Keywords

  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • adult acute promyelocytic leukemia (M3)
  • childhood acute promyelocytic leukemia (M3)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
03

In context

Leukemia

5,442 studies on the registry are indexed under Leukemia; 637 are open to participants now.

Browse Leukemia studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Enrollment
0 participants (actual)

Interventions

  • Drughomoharringtonine
  • Procedurechemotherapy
06

What researchers measure

Primary outcomes

  1. 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

  2. Efficacy by response to treatment

Secondary outcomes

  1. Pharmacokinetics

  2. Duration of treatment response

  3. Survival

  4. Induction mortality

  5. Hospitalizations

07

Study locations

1 site
  • M. D. Anderson Cancer Center at University of Texas
    Houston, Texas 77030-4009, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00030355
Lead sponsor
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Last update
Mar 22, 2013

Study contacts

Jorge Cortes, MD
study chair · M.D. Anderson Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

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