Arsenic Trioxide for Induction Therapy of Adult Patients With Leukemia

• Status: Terminated
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide

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