Arsenic Trioxide in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2006-09-01
• 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 relapsed or refractory acute lymphoblastic leukemia.

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

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Arsenic Trioxide

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