Status:
SUSPENDED
BL22 Immunotoxin In Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
Lead Sponsor:
MedImmune LLC
Collaborating Sponsors:
Cambridge Antibody Technology
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
6-24 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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. * Determ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00077493
Start Date
January 1 2004
End Date
October 1 2008
Last Update
December 28 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182