Know Cancer

or
forgot password

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


Phase 1/Phase 2
12 Years
N/A
Not Enrolling
Both
Leukemia

Thank you

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 TexasHouston, Texas  77030-4009