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A Phase I/II Study To Determine The Safety, Tolerability, And Anti-Leukemic Effects of Trisenox (Arsenic Trioxide) In Combination With Gleevec (STI571) In Patients With Resistant Chronic Myelogenous Leukemia In Chronic Phase


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

Thank you

Trial Information

A Phase I/II Study To Determine The Safety, Tolerability, And Anti-Leukemic Effects of Trisenox (Arsenic Trioxide) In Combination With Gleevec (STI571) In Patients With Resistant Chronic Myelogenous Leukemia In Chronic Phase


OBJECTIVES:

- Determine the safety and tolerability of arsenic trioxide and imatinib mesylate in
patients with resistant chronic phase chronic myelogenous leukemia.

- Determine potential dose-limiting toxic effects in patients treated with this regimen.

- Determine the pharmacokinetics of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily and arsenic trioxide IV over 1-2 hours on
days 1-5 of week 1 and then twice weekly. Treatment continues for 1 year in the absence of
disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 18-24 patients (at least 6 patients for phase I and at least
12 patients for phase II) will be accrued for this study .

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Cytogenetically confirmed Philadelphia chromosome-positive (Ph+) chronic myelogenous
leukemia, meeting one of the following criteria:

- Chronic phase

- Less than 15% blasts in peripheral blood or marrow

- Less than 30% blasts and promyelocytes in peripheral blood or marrow

- Less than 20% basophils in blood or marrow

- Platelet count at least 100,000/mm^3 (unless therapy related)

- No progressive (increase of at least 10 cm in any 4 of the past 24 weeks)
or existing (greater than 10 cm) splenomegaly

- Complete hematologic response (CHR)

- No immature myeloid cells in peripheral blood

- No increased basophils in peripheral blood

- WBC less than upper limit of normal (ULN)

- Platelet count less than ULN

- No major (less than 35% Ph+) or complete (0% Ph+) cytogenetic response
after at least 6 months of imatinib mesylate

- Loss of prior major cytogenetic response or failure to achieve major
cytogenetic response

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

Hepatic

- Bilirubin less than 1.5 times ULN

- AST or ALT less than 2.5 times ULN

Renal

- Creatinine less than 1.5 times ULN

Cardiovascular

- No New York Heart Association grade III or IV congestive heart failure

- No untreated symptomatic cardiac ischemia

- No underlying cardiac arrhythmia, including but not limited to any of the following:

- Conduction abnormality/atrioventricular heart block

- Nodal/junctional arrhythmia/dysrhythmia

- Sinus bradycardia or tachycardia

- Supraventricular tachycardia

- Ventricular arrhythmia

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 methods of effective barrier contraception during and for
3 months after study

- Electrolyte levels (especially potassium and magnesium) normal (CHR patients)

- No history of noncompliance that would preclude study participation

- No other concurrent serious, uncontrolled medical condition

- No grade 2 or greater neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- More than 14 days since prior therapy except hydroxyurea, anagrelide hydrochloride,
or imatinib mesylate

- More than 28 days since prior investigational agents

- No concurrent grapefruit or grapefruit juice

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Satey and Tolerability

Safety Issue:

Yes

Principal Investigator

Michael Mauro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000269319

NCT ID:

NCT00053248

Start Date:

October 2002

Completion Date:

June 2005

Related Keywords:

  • Leukemia
  • chronic phase chronic myelogenous leukemia
  • Philadelphia chromosome positive chronic myelogenous leukemia
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Name

Location

OHSU Knight Cancer Institute Portland, Oregon  97239
H. Lee Moffitt Cancer Center Tampa, Florida  33612
UCLA Department of Medicine, Division of Hematology/Oncology Los Angeles, California  90095