Purpose:
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients
who have relapsed or refractory acute lymphoblastic leukemia.
Study summary:
OBJECTIVES:
- Determine the complete remission rate of patients with relapsed or refractory acute
lymphoblastic leukemia treated with arsenic trioxide.
- Determine the toxic effects of induction arsenic trioxide in this patient population.
OUTLINE: Patients are stratified according to administration schedule of arsenic trioxide (5
days a week vs 7 days a week).
Patients receive arsenic trioxide IV over 1 hour daily until bone marrow blasts are less
than 5% or for a maximum of 60 days. Beginning 3-6 weeks after induction, patients achieving
a complete remission receive arsenic trioxide IV over 1 hour daily either 5 days or 7 days a
week for 25 days. Subsequent consolidation courses are given with 4 week treatment-free
intervals between courses. Treatment continues for a maximum of 5 consolidation courses in
the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 13-40 patients will be accrued for this study within 3 years.
Criteria:
DISEASE CHARACTERISTICS:
- Morphologically proven acute lymphoblastic leukemia (ALL)
- Subtypes L1, L2, or L3
- Bone marrow morphology with greater than 25% lymphoblasts
- ALL morphology and cytochemistry with myeloid markers eligible
- Refractory to induction therapy or relapsed following chemotherapy or autologous
blood or bone marrow transplantation
- Any number of prior relapses allowed
- No relapse following allogeneic transplantation
- Prior CNS leukemia allowed if treated and currently disease-free
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 6 months
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2.0 mg/dL
- SGOT/SGPT no greater than 2 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2 times ULN
Renal:
- Creatinine no greater than 2 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No significant active infection
- No other medical conditions that would likely decrease life expectancy
- No other prior malignancy within the past 5 years except cured basal or squamous cell
skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- At least 2 weeks since prior systemic corticosteroids
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent antibiotics for active or resolving infection