Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Terminated; Phase 2

Conditions: Leukemia

Treatments: Drug: Arsenic Trioxide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00006092

NCI-1230 (Other Identifier)

MCC-12395

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Arsenic Trioxide Treatment

Experimental group

Description:

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.

Treatment:

Drug: Arsenic Trioxide