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

Eastern Cooperative Oncology Group

Status and phase: Completed; Phase 2

Conditions: Leukemia

Treatments: Drug: arsenic trioxide

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00006008

CDR0000068016

E-9998

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 relapsed or refractory acute lymphoblastic leukemia.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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