Expired Study
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Madison, Wisconsin 53792


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00006008


Primary Contact:

Study Chair
Mark R. Litzow, MD
Mayo Clinic


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin 53792
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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