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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085150 |
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 treating young patients with relapsed or refractory leukemia or lymphoma.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma |
Drug: LMB-2 immunotoxin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pediatric Phase I Trial of LMB-2 for Refractory CD25-Positive Leukemias and Lymphomas |
Estimated Enrollment: | 40 |
Study Start Date: | April 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive LMB-2 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression, neutralizing antibodies (i.e., > 75% of the activity of 1 µg/mL of LMB-2 immunotoxin), or unacceptable toxicity. Patients achieving complete remission (CR) receive 2 additional courses beyond CR. Patients with acute lymphoblastic leukemia also receive cytarabine and hydrocortisone intrathecally once monthly concurrent with restaging lumbar punctures.
Cohorts of 3-6 patients receive escalating doses of LMB-2 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, a total of 12 patients are treated at that dose level.
Patients are followed weekly for 1 month and then monthly thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 2-4 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Non-Hodgkin's lymphoma, including the following subtypes:
Acute lymphoblastic leukemia (ALL)
Acute hybrid leukemia, including the following subtypes:
CD25-positive (CD25+) disease, meeting 1 of the following criteria:
No CNS leukemia or lymphoma, as evidenced by any of the following criteria:
CNS lymphoma detected by radiological imaging
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
For patients without bone marrow involvement:
Hepatic
Renal
Creatinine, meeting the following age-related criteria:
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Concurrent corticosteroids allowed provided the dose has been stable for the past week and does not increase during study treatment
Radiotherapy
Surgery
Other
United States, Georgia | |
Winship Cancer Institute of Emory University | |
Atlanta, Georgia, United States, 30322 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 | |
United States, Oregon | |
Doernbecher Children's Hospital at Oregon Health & Science University | |
Portland, Oregon, United States, 97239-3098 | |
United States, Tennessee | |
St. Jude Children's Research Hospital | |
Memphis, Tennessee, United States, 38105 |
Principal Investigator: | Alan S. Wayne, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000367333, NCI-04-C-0168, NCI-5903 |
Study First Received: | June 10, 2004 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00085150 |
Health Authority: | United States: Food and Drug Administration |
recurrent adult T-cell leukemia/lymphoma recurrent childhood acute lymphoblastic leukemia Burkitt lymphoma recurrent childhood acute myeloid leukemia recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma |
recurrent mycosis fungoides/Sezary syndrome recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma relapsing chronic myelogenous leukemia acute undifferentiated leukemia |
Sezary syndrome Leukemia, Lymphoid Hodgkin's disease Chronic myelogenous leukemia Cutaneous T-cell lymphoma Lymphoma, small cleaved-cell, diffuse Sezary Syndrome Mycosis Fungoides Leukemia, Myeloid, Acute Antibodies, Monoclonal Lymphoma, large-cell Burkitt's lymphoma Leukemia Mycoses Lymphoma, T-Cell |
Acute myelocytic leukemia Hodgkin Disease Lymphoma Immunoglobulins Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Leukemia-Lymphoma, Adult T-Cell Acute myelogenous leukemia Lymphoblastic lymphoma Leukemia, Myeloid Immunotoxins Recurrence Lymphatic Diseases Antibodies |
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |