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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00024115
First received: September 13, 2001
Last updated: January 11, 2007
Last verified: December 2006
  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 1

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00024115

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: Robert Kreitman, MD National Cancer Institute (NCI)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00024115     History of Changes
Obsolete Identifiers: NCT00021593
Other Study ID Numbers: CDR0000068892, NCI-01-C-0213, NCI-5336
Study First Received: September 13, 2001
Last Updated: January 11, 2007
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Immunologic Factors
Immunotoxins
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014