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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Antibodies; Immunologic Factors; Immunotoxins

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