Pediatric Phase I Trial of BL22 for Refractory CD22-Positive Leukemias and Lymphomas

Date de début de l'étude : 1 janvier 2004

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