BL22 Immunotoxin In Treating Young Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
NCT ID: NCT00077493
Last Updated: 2007-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE1
95 participants
INTERVENTIONAL
2004-01-31
2008-10-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
BL22 immunotoxin
BL22 immunotoxin
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.
2
antibody therapy
antibody-drug conjugate therapy
CD22 antibody, RFB4 on day 7
3
immunotoxin therapy
immunotoxin therapy
tested for immunogenicity to CAT-8015 before each cycle and at end of study.
4
monoclonal antibody therapy
monoclonal antibody therapy
administered intravenously over 30 minutes.
Interventions
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BL22 immunotoxin
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.
antibody-drug conjugate therapy
CD22 antibody, RFB4 on day 7
immunotoxin therapy
tested for immunogenicity to CAT-8015 before each cycle and at end of study.
monoclonal antibody therapy
administered intravenously over 30 minutes.
Eligibility Criteria
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Inclusion Criteria
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
6 Months
24 Years
ALL
No
Sponsors
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Cambridge Antibody Technology
OTHER
MedImmune LLC
INDUSTRY
Responsible Party
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MedImmune Inc.
Principal Investigators
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Alan S. Wayne, MD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States
Countries
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Other Identifiers
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NCI-04-C-0079H
Identifier Type: -
Identifier Source: secondary_id
NCI-5643
Identifier Type: -
Identifier Source: secondary_id
CDR0000352020
Identifier Type: -
Identifier Source: org_study_id
NCT00075309
Identifier Type: -
Identifier Source: nct_alias