Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia

NCT ID: NCT00030355

Last Updated: 2013-03-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL

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.

Conditions

Leukemia

Study Design

• Primary Study Purpose: TREATMENT

Interventions

homoharringtonine

Intervention Type: DRUG

chemotherapy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Jorge Cortes, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Countries

United States

Other Identifiers

CHEMGENEX-CGX-635-APL-101

Identifier Type: -

Identifier Source: secondary_id

MDA-DM-01265

Identifier Type: -

Identifier Source: secondary_id

CDR0000069158

Identifier Type: -

Identifier Source: org_study_id