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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00024115 |
Purpose
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 |
| 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.
Eligibility| 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:
Contacts and Locations| 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) |
More Information
| Study ID Numbers: | CDR0000068892, NCI-01-C-0213, NCI-5336 |
| Study First Received: | September 13, 2001 |
| Last Updated: | January 11, 2007 |
| ClinicalTrials.gov Identifier: | NCT00024115 History of Changes |
| Health Authority: | United States: Federal Government |
|
refractory chronic lymphocytic leukemia B-cell chronic lymphocytic leukemia stage III grade I follicular small cleaved cell lymphoma stage III grade II follicular mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV grade I follicular small cleaved cell lymphoma stage IV grade II follicular mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma recurrent grade I follicular small cleaved cell lymphoma recurrent grade II follicular mixed cell lymphoma recurrent grade III follicular large cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
recurrent adult lymphoblastic lymphoma recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma prolymphocytic leukemia contiguous stage II grade I follicular small cleaved cell lymphoma contiguous stage II grade II follicular mixed cell lymphoma contiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II grade I follicular small cleaved cell lymphoma noncontiguous stage II grade II follicular mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma stage III diffuse small lymphocytic/marginal zone lymphoma contiguous stage II diffuse small lymphocytic/marginal zone lymphoma noncontiguous stage II diffuse small lymphocytic/marginal zone lymphoma stage IV diffuse small lymphocytic/marginal zone lymphoma recurrent diffuse small lymphocytic/marginal zone lymphoma recurrent mantle cell lymphoma |
|
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Physiological Effects of Drugs Lymphoma, Follicular Pharmacologic Actions Immunotoxins |
Leukemia Lymphatic Diseases Antibodies Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |