A Dose-ranging Phase I/II Study of STI571 in Combination With Cytarabin in Patients With First Chronic Phase Chronic Myeloid Leukemia
18 Years
65 Years
Both
Leukemia
Trial Information
A Dose-ranging Phase I/II Study of STI571 in Combination With Cytarabin in Patients With First Chronic Phase Chronic Myeloid Leukemia
OBJECTIVES:
- Determine the maximum tolerated dose of imatinib mesylate and cytarabine in patients
with newly diagnosed chronic phase chronic myeloid leukemia.
- Determine the feasibility of this regimen as defined by dose-limiting toxicity of this
regimen and treatment-related mortality in no more than 5% of these patients.
- Determine the rate and duration of molecular response, complete hematological response,
and complete cytogenetic response in patients treated with this regimen.
- Determine the time to treatment failure of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of imatinib mesylate and cytarabine.
Patients receive oral imatinib mesylate alone once daily on days 1-21. Patients then receive
oral imatinib mesylate once daily and cytarabine IV over 1-3 hours on days 1-7. Combination
therapy repeats every 28-42 days for 2 courses. Patients then receive maintenance oral
imatinib mesylate once daily. Treatment continues in the absence of disease progression or
unacceptable toxicity.
Cohorts of 5-20 patients receive escalating doses of imatinib mesylate and cytarabine until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding
that at which at least 5/5, 5/10, or 5/20 patients experience dose-limiting toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 2 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed chronic myeloid leukemia in first chronic phase (within the past 6
months)
- Philadelphia-chromosome positive OR
- bcr-abl rearrangement
- No prior treatment within the past 6 months other than hydroxyurea
PATIENT CHARACTERISTICS:
Age:
- 18 to 65
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- No hepatic dysfunction
- Bilirubin less than 2 times normal
- ALT less than 4 times normal
Renal:
- No renal dysfunction
- Creatinine less than 2.3 mg/dL
Cardiovascular:
- No severe cardiac dysfunction
- No New York Heart Association class II-IV heart disease
Pulmonary:
- No severe pulmonary disease
Other:
- HIV negative
- No severe neurologic disease
- No active uncontrolled infection
- No other active malignancy within the past 5 years except basal cell skin cancer or
stage 0 cervical cancer
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No concurrent allogeneic transplantation with an HLA-A, B, DR-matched sibling donor
or matched-unrelated donor
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- See Disease Characteristics
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
Other:
- No concurrent grapefruit or grapefruit juice
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Incidence of dose-limiting toxicity and treatment-related toxicity per dose level
Safety Issue:
Yes
Principal Investigator
J.J. Cornelissen, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000069141
NCT ID:
NCT00028847
Start Date:
April 2001
Completion Date:
Related Keywords:
- Leukemia
- chronic phase chronic myelogenous leukemia
- chronic myelogenous leukemia, BCR-ABL1 positive
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Leukemia, Myeloid, Chronic-Phase
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