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.
Allocation: Non-Randomized, Primary Purpose: Treatment
Feasibility of using fludarabine phosphate and cyclophosphamide to decrease neutralizing antibodies
Robert Kreitman, MD
National Cancer Institute (NCI)
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|