Non Hodgkin Lymphoma Clinical Trial

BL22 Immunotoxin in Treating Patients With Non-Hodgkin’s Lymphoma or Chronic Lymphocytic Leukemia

Summary

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.

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Full Description

OBJECTIVES:

Determine the toxicity and therapeutic efficacy of recombinant BL22 immunotoxin in patients with CD22-positive B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Determine the pharmacokinetics, including the terminal elimination serum half-life area under the curve and volume of distribution, of recombinant BL22 immunotoxin in these patients.
Determine the immunogenicity of recombinant BL22 immunotoxin in these patients.
Determine the effect of recombinant BL22 immunotoxin on various components of the circulating cellular immune system in these patients.

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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed chronic lymphocytic leukemia or prolymphocytic leukemia:
Failed prior standard chemotherapy and treatment is medically indicated as evidenced by the following:
Progressive disease-related symptoms
Progressive cytopenias due to marrow involvement
Progressive or painful splenomegaly or adenopathy
Rapidly increasing lymphocytosis
Autoimmune hemolytic anemia or thrombocytopenia
Increased frequency of infections OR
Confirmed CD22+ B-cell indolent non-Hodgkin's lymphoma
Stages II-IV that have failed at least 1 prior standard therapy and treatment is medically indicated
No patients whose serum neutralizes BL22 or PE38 in tissue culture, due to antitoxin or antimouse-IgG antibodies
No central nervous system disease requiring treatment
If the patient is non-leukemic, the absolute neutrophil count must be greater than 1,000/mm3 and the platelet count greater than 40,000/mm3

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Karnofsky 60-100%

Life expectancy:

More than 6 months

Hematopoietic:

See Disease Characteristics

Hepatic:

ALT and AST less than 5 times upper limit of normal

Renal:

Adequate renal function

Pulmonary:

Adequate pulmonary function

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Prior bone marrow transplantation allowed
At least 3 weeks since prior interferon for malignancy

Chemotherapy:

See Disease Characteristics
At least 3 weeks since prior cytotoxic chemotherapy for malignancy

Endocrine therapy:

Not specified

Radiotherapy:

At least 3 weeks since prior radiotherapy for malignancy

Surgery:

Not specified

Other:

At least 3 weeks since prior retinoids
At least 3 weeks since prior systemic therapy for cancer

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Study ID:

NCT00024115

Recruitment Status:

Withdrawn

Sponsor:

National Cancer Institute (NCI)

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There is 1 Location for this study

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Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda Maryland, 20892, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Study ID:

NCT00024115

Recruitment Status:

Withdrawn

Sponsor:


National Cancer Institute (NCI)

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