Status:
COMPLETED
LMB-2 Immunotoxin in Treating Young Patients With Relapsed or Refractory Leukemia or Lymphoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
RATIONALE: LMB-2 immunotoxin can locate cancer cells and kill them without harming normal cells. PURPOSE: This phase I trial is studying the side effects and best dose of LMB-2 immunotoxin in treatin...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of LMB-2 immunotoxin in pediatric patients with CD-25 positive relapsed or refractory leukemia or lymphoma. * Determine the toxic effects o...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following:
- Non-Hodgkin's lymphoma, including the following subtypes:
- Lymphoblastic lymphoma
- Burkitt's lymphoma
- Large cell lymphoma
- Adult T-cell leukemia/lymphoma
- Cutaneous T-cell lymphoma
- Peripheral T-cell lymphoma
- Hodgkin's disease
- Acute myeloid leukemia
- Chronic myelogenous leukemia
- Acute lymphoblastic leukemia (ALL)
- More than 5% blasts in the bone marrow (i.e., M2 marrow classification)
- Acute hybrid leukemia, including the following subtypes:
- Mixed lineage leukemia
- Biphenotypic leukemia
- Undifferentiated leukemia
- CD25-positive (CD25+) disease, meeting 1 of the following criteria:
- More than 15% of malignant cells are CD25+ by immunohistochemistry with anti-CD25 antibody
- More than 30% of malignant cells from a site are CD25+ by fluorescence-activated cell sorting analysis
- Measurable or evaluable disease
- Relapsed or refractory disease after at least 1 standard chemotherapy regimen AND 1 salvage regimen
- No available alternative curative therapies
- Ineligible for or refused hematopoietic stem cell transplantation OR disease activity that prohibits the required time to identify a suitable stem cell donor
- No CNS leukemia or lymphoma, as evidenced by any of the following criteria:
- Cerebrospinal fluid (CSF) WBC \> 5/µl AND confirmation of CSF blasts
- Cranial neuropathies secondary to underlying malignancy
- CNS lymphoma detected by radiological imaging
- Prior CNS involvement with no current evidence of CNS malignancy allowed
- No isolated testicular ALL
- PATIENT CHARACTERISTICS:
- Age
- 6 months to 21 years
- Performance status
- ECOG 0-3 (≥ 12 years of age)
- Lansky 40-100% (\< 12 years of age)
- Life expectancy
- Not specified
- Hematopoietic
- Pancytopenia due to disease allowed
- For patients without bone marrow involvement:
- Absolute neutrophil count \> 1,000/mm\^3
- Platelet count \> 50,000/mm\^3 (transfusion independent)
- Hepatic
- Bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 5 times upper limit of normal
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
- Renal
- Creatinine clearance ≥ 60 mL/min OR
- Creatinine, meeting the following age-related criteria:
- ≤ 0.8 mg/dL (≤ 5 years of age)
- ≤ 1.0 mg/dL (6 to 10 years of age)
- ≤ 1.2 mg/dL (11 to 15 years of age)
- ≤ 1.5 mg/dL (\> 15 years of age)
- Calcium 2.0-2.9 mmol/L
- Cardiovascular
- Ejection fraction ≥ 45% by MUGA OR
- Shortening fraction ≥ 28% by echocardiogram
- Pulmonary
- Oxygen saturation ≥ 90%
- Other
- Sodium 130-150 mmol/L
- Potassium 3.0-5.5 mmol/L
- Magnesium 0.5-1.23 mmol/L
- HIV negative
- 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 conditions that would preclude study compliance
- No serum that neutralizes \> 75% of the activity of 1 μg/mL of LMB-2 immunotoxin in tissue culture (due to either anti-toxin or anti-mouse immunoglobulin G antibodies)
- No active graft-vs-host disease (i.e., off immunosuppression)
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Prior autologous bone marrow transplantation (BMT) allowed
- At least 100 days since prior allogeneic BMT
- At least 1 week since prior colony-stimulating factors (e.g., filgrastim \[G-CSF\], sargramostim \[GM-CSF\], or epoetin alfa)
- Chemotherapy
- At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) except intrathecal chemotherapy
- No other concurrent chemotherapy
- Endocrine therapy
- Concurrent corticosteroids allowed provided the dose has been stable for the past week and does not increase during study treatment
- Tapering or discontinuation of steroids allowed
- Radiotherapy
- At least 3 weeks since prior radiotherapy unless \< 10% of marrow is irradiated and measurable disease exists outside the radiation port
- Surgery
- Not specified
- Other
- Recovered from all prior therapy
- At least 30 days since prior investigational agents
- Concurrent oral supplementation to maintain normal electrolyte levels allowed
- No concurrent anticoagulation therapy for disease-related conditions
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00085150
Start Date
April 1 2004
Last Update
April 30 2015
Active Locations (5)
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1
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
2
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
3
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
4
Doernbecher Children's Hospital at Oregon Health & Science University
Portland, Oregon, United States, 97239-3098