Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00030355
• Other study ID #: CDR0000069158
• Secondary ID: CHEMGENEX-CGX-63
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: February 14, 2002
• Last updated: March 21, 2013

Study information

• Verified date: September 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Promyelocytic, Acute

Intervention

Drug:
• homoharringtonine

Procedure:
• chemotherapy

Locations

Country	Name	City	State
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Efficacy by response to treatment
Secondary	Pharmacokinetics
Secondary	Duration of treatment response
Secondary	Survival
Secondary	Induction mortality
Secondary	Hospitalizations