Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00030355
First received: February 14, 2002
Last updated: March 21, 2013
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Leukemia
Drug: homoharringtonine
Procedure: chemotherapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I/II Open-Label Study Of The Intravenous Administration Of Homoharringtonine (CGX-635) Salvage Therapy For The Treatment Of Refractory Acute Promyelocytic Leukemia

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Pharmacokinetics
  • Duration of treatment response
  • Survival
  • Induction mortality
  • Hospitalizations

Enrollment: 0
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030355

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Investigators
Study Chair: Jorge Cortes, MD M.D. Anderson Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00030355     History of Changes
Other Study ID Numbers: CDR0000069158, CHEMGENEX-CGX-635-APL-101, MDA-DM-01265
Study First Received: February 14, 2002
Last Updated: March 21, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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)

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Homoharringtonine
Harringtonines
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014