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Sponsored by: |
National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00024115 |
RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of the BL22 immunotoxin in treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Condition | Intervention | Phase |
Leukemia Lymphoma |
Drug: BL22 immunotoxin Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: immunotoxin therapy |
Phase I |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Recombinant BL22 Immunotoxin in Patients With CD22-Positive B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Patients may be retreated at least every 20 days for up to 25 courses in the absence of disease progression and sufficient neutralizing antibodies.
Cohorts of 3-6 patients receive escalating doses of recombinant BL22 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |||||
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |||||
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Robert Kreitman, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000068892, NCI-01-C-0213, NCI-5336 |
First Received: | September 13, 2001 |
Last Updated: | January 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00024115 |
Health Authority: | United States: Federal Government |
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