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Phase I Study of Recombinant BL22 Immunotoxin in Patients With CD22-Positive B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma

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Trial Information

Phase I Study of Recombinant BL22 Immunotoxin in Patients With CD22-Positive B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert Kreitman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000068892

NCT ID:

NCT00024115

Start Date:

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • 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
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Follicular

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182