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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00021983 |
RATIONALE: An immunotoxin can locate cancer cells and kill them without harming normal cells. This may be an effective treatment for hairy cell leukemia.
PURPOSE: Phase I trial to study the effectiveness of BL22 immunotoxin in treating patients who have refractory or recurrent hairy cell leukemia.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: BL22 immunotoxin |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of BL22, a Recombinant Immunotoxin for Treatment of CD22+ Leukemias and Lymphomas |
Study Start Date: | December 1998 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive recombinant BL22 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats at least every 42 days for up to 4 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 at which no more than 1 of 6 patients experiences dose-limiting toxicity.
PROJECTED ACCRUAL: A maximum of 46 patients will be accrued for this study within 3 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed refractory or recurrent hairy cell leukemia
Must have at least one of the following indications for therapy:
Cytopenia defined by the following:
Evidence of CD22 positivity by 1 of the following:
No patients whose serum neutralizes BL22 immunotoxin in tissue culture, due to either antitoxin or antimouse-IgG antibodies
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: | CDR0000066835, NCI-99-C-0014, NCI-T98-0063 |
Study First Received: | August 10, 2001 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00021983 |
Health Authority: | United States: Federal Government |
refractory hairy cell leukemia |
Lymphatic Diseases Leukemia Leukemia, Hairy Cell Immunoproliferative Disorders |
Lymphoproliferative Disorders Hairy cell leukemia Lymphoma Immunotoxins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |