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

Primary Purpose

Leukemia, Lymphoma

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BL22 immunotoxin
antibody therapy
biological response modifier therapy
immunotoxin therapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2001
Last Updated
April 27, 2015
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00024115
Brief Title
BL22 Immunotoxin in Treating Patients With Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Official Title
Phase I Study of Recombinant BL22 Immunotoxin in Patients With CD22-Positive B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BL22 immunotoxin
Intervention Type
Procedure
Intervention Name(s)
antibody therapy
Intervention Type
Procedure
Intervention Name(s)
biological response modifier therapy
Intervention Type
Procedure
Intervention Name(s)
immunotoxin therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kreitman, MD
Organizational Affiliation
National Cancer Institute (NCI)
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

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

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