BL22 Immunotoxin In Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
Leukemia, Lymphoma
About this trial
This is an interventional treatment trial for Leukemia focused on measuring recurrent childhood acute lymphoblastic leukemia, Burkitt lymphoma, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, childhood non-Hodgkin lymphoma
Eligibility 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
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
1
2
3
4
BL22 immunotoxin
antibody therapy
immunotoxin therapy
monoclonal antibody therapy