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

Inclusion 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