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
12 Years
N/A
Both
Leukemia
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
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
Principal Investigator
Jorge Cortes, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
Unspecified
Study ID:
CDR0000069158
NCT ID:
NCT00030355
Start Date:
Completion Date:
Related Keywords:
- Leukemia
- 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)
- Leukemia
- Leukemia, Promyelocytic, Acute
Name | Location |
|---|---|
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
