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A Pilot Study of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Hodgkin's Disease After Fludarabine and Cyclophosphamide

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Trial Information

A Pilot Study of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Hodgkin's Disease After Fludarabine and Cyclophosphamide



- Determine the feasibility of pretreatment with fludarabine phosphate and
cyclophosphamide in preventing neutralization of antibodies in patients with
CD25-positive Hodgkin's lymphoma.


- Determine the response rate in patients treated with LMB-2 immunotoxin.

- Determine the response duration in patients receiving this treatment.

- Correlate serum levels of LMB-2 immunotoxin with toxicity and response in these

- Assess the development of neutralizing antibodies and the effect of these antibodies on
blood levels of LMB-2 immunotoxin and toxicity.

- Correlate soluble Tac-peptide levels with treatment response in these patients.

OUTLINE: This is a nonrandomized, pilot study.

Patients receive fludarabine phosphate IV over 30 minutes and cyclophosphamide IV over 60
minutes on days 1-4 and filgrastim (G-CSF) subcutaneously once daily beginning on day 5 and
continuing until blood counts recover.

Beginning 4 weeks after completion of chemotherapy, patients receive LMB-2 immunotoxin IV
over 30 minutes on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses in
the absence of disease progression.

Blood is obtained prior to and after chemotherapy and then periodically during LMB-2
immunotoxin therapy for pharmacokinetic studies to measure lymphocyte subsets.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion Criteria


- Histopathologically confirmed CD25+ Hodgkin's lymphoma

- At least 20% of the malignant cells positive by immunohistochemistry

- Stage II-IV disease

- Meets the following criteria:

- Failed standard chemotherapy

- Not eligible for curative salvage radiotherapy or chemotherapy

- Not eligible for or refused bone marrow transplantation

- Measurable disease

- No patient whose serum neutralizes LMB-2 immunotoxin in tissue culture, due either to
antitoxin or antimouse-IgG antibodies

- No patient whose serum neutralizes > 75% of the activity of 1 µg/mL of LMB-2


- ECOG performance status 0-2

- Absolute neutrophil count ≥ 1,000/mm³

- Platelet count ≥ 50,000/mm³

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- ALT and AST ≤ 2.5 times upper limit of normal

- Albumin ≥ 3.0 g/dL

- Bilirubin ≤ 2.2 mg/dL (< 5 mg/dL if Gilbert's syndrome is present)

- Creatinine ≤ 1.4 mg/dL OR creatinine clearance ≥ 50 mL/min

- No uncontrolled intercurrent illness including, but not limited to, any of the

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness or social situations that would limit study compliance

- No HIV or hepatitis C positivity

- Hepatitis B surface antigen positivity allowed provided patient is receiving

- LVEF ≥ 45%

- DLCO ≥ 50% of normal OR FEV_1 ≥ 60% of normal

- No active second malignancy requiring treatment


- See Disease Characteristics

- No systemic cytotoxic chemotherapy within the past 4 weeks

- No systemic steroids (except stable doses of prednisone ≤ 20 mg/day) within the past
4 weeks

- No monoclonal antibody therapy within the past 12 weeks

- No prior LMB-2 immunotoxin

- No concurrent warfarin

Type of Study:


Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Feasibility of using fludarabine phosphate and cyclophosphamide to decrease neutralizing antibodies

Safety Issue:


Principal Investigator

Robert Kreitman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

May 2008

Related Keywords:

  • Lymphoma
  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma



Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182