Spots Global Cancer Trial Database for Immunotoxin Therapy in Treating Patients With Hairy Cell Leukemia

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Trial Identification

Brief Title: Immunotoxin Therapy in Treating Patients With Hairy Cell Leukemia

Official Title: Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas

Study ID: NCT00021983

Conditions

Leukemia

Interventions

BL22 immunotoxin

Study Description

Brief Summary: RATIONALE: An immunotoxin can locate cancer cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia. PURPOSE: Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients who have refractory or recurrent hairy cell leukemia.

Detailed Description: OBJECTIVES: * Assess the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with refractory or recurrent CD22+ hairy cell leukemia. * Define the pharmacokinetics of this drug, including the terminal elimination serum half-life area under the curve and volume of distribution, in these patients. * Evaluate the immunogenicity of this drug in these patients. * Determine the effect of this drug on various components of the circulating cellular immune system in these patients. OUTLINE: This is a dose-escalation study. Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats at least every 42 days for up to 4 courses in the absence of disease progression and sufficient neutralizing antibodies. Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. PROJECTED ACCRUAL: A maximum of 46 patients will be accrued for this study within 3 years.