Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. BL22 immunotoxin may be effective in treating relapsed or refractory acute lymphoblastic leukemia and non-Hodgkin's lymphoma. PURPOSE: This phase I trial is studying the side effects and best dose of BL22 immunotoxin in treating young patients with relapsed or refractory acute lymphoblastic leukemia or non-Hodgkin's lymphoma.


Study summary:

OBJECTIVES: Primary - Determine the toxic effects of BL22 immunotoxin in pediatric patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia or non-Hodgkin's lymphoma. - Determine the maximum tolerated dose of this drug in these patients. - Determine the immunogenicity of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. Secondary - Determine the in vitro cytotoxicity of this drug against lymphoblasts from patients with acute lymphoblastic leukemia. - Determine the therapeutic efficacy of this drug in inducing remissions in these patients. - Determine changes in lymphocyte subsets, immunoglobulin levels, serum cytokines, and soluble cytokine receptor levels in patients treated with this drug. OUTLINE: This is a non-randomized, dose-escalation study. Patients receive BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5 OR on days 1, 3, 5, 7, 9, and 11. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) or unconfirmed CR (CRu) receive 2 additional courses beyond CR or CRu for a maximum of 6 courses. Cohorts of 3-6 patients receive escalating doses of BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, the cohort is expanded and a total of 12 patients are treated at that dose. Patients are followed weekly for at least 1 month and then every 1-3 months thereafter. PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed acute lymphoblastic leukemia (ALL) or non-Hodgkin's lymphoma (including lymphoblastic lymphoma, Burkitt's lymphoma, and large cell lymphoma) - Not amenable to available curative therapies - Relapsed or refractory disease after at least 1 standard chemotherapy and 1 salvage regimen - CD22 positive according to at least 1 of the following criteria: - More than 15% CD22-positive malignant cells by immunohistochemistry - More than 30% CD22-positive malignant cells by fluorescent-activated cell sorter analysis - Measurable or evaluable disease - Prior CNS involvement allowed provided there is no current evidence of CNS malignancy - No CNS leukemia or lymphoma as manifested by any of the following: - Cerebrospinal fluid (CSF) WBC ≥ 5/mm^3 and confirmation of CSF blasts - Cranial neuropathies secondary to underlying malignancy - Radiologically detected CNS lymphoma - No isolated testicular ALL - Ineligible for or refused hematopoietic stem cell transplantation OR has disease activity that prohibits the time required to identify a suitable stem cell donor PATIENT CHARACTERISTICS: Age - 6 months to 24 years Performance status - ECOG 0-3 (12 to 24 years of age) - Lansky 40-100% (under 12 years of age) Life expectancy - Not specified Hematopoietic - See Disease Characteristics - Absolute neutrophil count > 1,000/mm^3 * - Platelet count > 50,000/mm^3 * NOTE: *Non-leukemic patients only Hepatic - Bilirubin ≤ 2.0 mg/dL - AST and ALT ≤ 5 times upper limit of normal - No active hepatitis B or C infection Renal - Creatinine normal for age OR - Creatinine clearance ≥ 60 mL/min Immunologic - No serum neutralization of more than 75% of the activity of 1 µg/mL of study drug - HIV negative Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No clinically significant unrelated systemic illness that would preclude study participation - No other significant organ dysfunction that would preclude study participation - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - At least 1 week since prior colony-stimulating factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or epoetin alfa) - Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT) allowed - More than 100 days since prior allogeneic HSCT Chemotherapy - See Disease Characteristics - At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy - Concurrent corticosteroids allowed provided there has been no increase in the dose 1 week prior to and after study entry - Steroid taper allowed Radiotherapy - At least 3 weeks since prior radiotherapy - Allowed in the past 3 weeks provided the volume of the bone marrow treated is < 10% AND the patients has measurable disease outside of the radiation port Surgery - Not specified Other - Recovered from prior therapy - At least 30 days since prior investigational drugs - No other concurrent investigational drugs


NCT ID:

NCT00077493


Primary Contact:

Principal Investigator
Alan S. Wayne, MD
NCI - Pediatric Oncology Branch


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: June 25, 2018

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