Homoharringtonine in Treating Patients With Refractory Acute Promyelocytic Leukemia

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Withdrawn

CT.gov ID

NCT00030355

Collaborator

(none)

Enrollment

Location

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Drug: homoharringtonine Procedure: chemotherapy	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

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

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts 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