Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia

Study Overview
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Brief Summary
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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 recurrent or refractory acute lymphoblastic leukemia or chronic myelogenous leukemia.

Detailed Description
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OBJECTIVES: Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide. Determine the duration of hematologic response and overall survival of these patients when treated with this regimen. Determine the pattern of clinical adverse experience in these patients when treated with this regimen. Determine the pharmacokinetic profile of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course. Patients are followed monthly for 3 months, every 2 months for 6 months, and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 24-49 patients will be accrued for this study within 2.5 years.

Official Title
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A Phase II Study of Arsenic Trioxide for Induction Therapy of Adult Patients With Relapsed or Refractory Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia and Previously Untreated Chronic Myeloid Leukemia With Blast Crisis

Conditions
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Leukemia

Intervention / Treatment
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* Drug: Arsenic Trioxide


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of one of the following: Acute lymphoblastic leukemia Philadelphia chromosome (Bcr-abl) positive Refractory to initial therapy OR recurrent following 1 induction therapy regimen with or without consolidation therapy and/or bone marrow transplantation Blastic phase chronic myelogenous leukemia Philadelphia chromosome (Bcr-abl) positive Previously untreated OR recurrent or refractory following 1 induction therapy regimen with or without consolidation therapy including imatinib mesylate Must not be eligible for bone marrow transplant PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy: At least 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 times upper limit of normal (ULN) AST/ALT no greater than 2 times ULN Renal: Creatinine no greater than 2.0 times ULN Creatinine clearance greater than 70 mL/min Cardiovascular: No uncontrolled angina No New York Heart Association class III or IV heart disease No second degree heart block without pacemaker Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study HIV negative No uncontrolled infection or other serious concurrent illness No peripheral neuropathy No potassium less than 3.0 or greater than 5.5 mEq/L that can not be corrected OR No magnesium less than 1.2 or greater than 2.5 mEq/L that can not be corrected Electrolyte imbalances must be corrected prior to study entry PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 28 days since prior chemotherapy At least 24 hours since prior hydroxyurea No prior arsenic trioxide No other concurrent cytotoxic chemotherapy except intrathecal chemotherapy for CNS leukemia Endocrine therapy: Not specified Radiotherapy: At least 28 days since prior radiotherapy No concurrent radiotherapy including for palliation Surgery: Not specified Other: At least 14 days since prior imatinib mesylate No other concurrent investigational agents No concurrent amphotericin B

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arsenic Trioxide Treatment<br>Patients receive arsenic trioxide IV over 2-3 hours daily for 28 days. Patients who respond may receive a second course of therapy beginning 28 days from the last dose of the first course. | Drug: Arsenic Trioxide<br> <br> * Other names: Trisenox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Rate of Response (ORR) | Determine the rate of clinical and hematologic response in patients with Philadelphia chromosome-positive recurrent or refractory acute lymphoblastic leukemia or previously untreated or recurrent or refractory blastic phase chronic myelogenous leukemia when treated with arsenic trioxide. | 2.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent adult acute lymphoblastic leukemia, relapsing chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive, lymphoid leukemia, myeloid and monocytic leukemia