Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed refractory or recurrent hairy cell leukemia - Relapsed after less than 2 years of complete remission after purine analog therapy - Must have at least one of the following indications for therapy: - Progressive or massive splenomegaly - Cytopenia defined by the following: - Absolute neutrophil count less than 1,000/mm^3 OR - Platelet count less than 100,000/mm^3 OR - Hemoglobin less than 12 g/dL - More than 20,000 hairy cells/mm^3 - Symptomatic adenopathy - Constitutional symptoms including tumor-related fever or bone pain - Evidence of CD22 positivity by 1 of the following: - More than 15% of malignant cells from a site must react with anti-CD22 by immunohistochemistry - More than 30% of malignant cells from a site CD22+ by fluorescent-activated cell sorter - More than 400 CD22 sites/cell (average) on malignant cells as assessed by radiolabeled anti-CD22 binding - No CNS disease requiring treatment - No patients whose serum neutralizes BL22 immunotoxin in tissue culture, due to either antitoxin or antimouse-IgG antibodies - No patients whose serum neutralizes more than 75% of the activity of 1 microgram/mL of BL22 immunotoxin PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - More than 6 months Hematopoietic: - See Disease Characteristics - Pancytopenia due to disease allowed Hepatic: - ALT and AST less than 2.5 times upper limit of normal (ULN) - Bilirubin less than 1.5 times ULN Renal: - Creatinine no greater than 2.0 mg/dL Pulmonary: - FEV1 at least 60% of predicted - DLCO at least 55% of predicted Other: - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior bone marrow transplantation allowed - At least 3 weeks since prior interferon for the malignancy - More than 3 months since prior monoclonal antibody therapy (e.g., rituximab) Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior cytotoxic chemotherapy for the malignancy Endocrine therapy: - Not specified Radiotherapy: - At least 3 weeks since prior whole body electron beam radiotherapy for the malignancy - Radiotherapy within the past 3 weeks allowed provided less than 10% of total bone marrow was treated and patient has measurable disease outside the radiation port Surgery: - Not specified Other: - At least 3 weeks since prior retinoids for the malignancy - At least 3 weeks since any other prior systemic therapy for the malignancy - No concurrent therapeutic warfarin


NCT ID:

NCT00021983


Primary Contact:

Study Chair
Robert Kreitman, MD
National Cancer Institute (NCI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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