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Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia

Primary Purpose

Leukemia

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
homoharringtonine
chemotherapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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)

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M. D. Anderson Cancer Center at University of Texas

Outcomes

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

Full Information

First Posted
February 14, 2002
Last Updated
March 21, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00030355
Brief Title
Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
homoharringtonine
Intervention Type
Procedure
Intervention Name(s)
chemotherapy
Primary Outcome Measure Information:
Title
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
Title
Efficacy by response to treatment
Secondary Outcome Measure Information:
Title
Pharmacokinetics
Title
Duration of treatment response
Title
Survival
Title
Induction mortality
Title
Hospitalizations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Cortes, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

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Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia

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