Fludarabine and Cyclophosphamide Followed By LMB-2 Immunotoxin in Treating Patients With Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. LMB-2 immunotoxin can find cancer cells and kill them without harming normal cells. Giving fludarabine and cyclophosphamide followed by LMB-2 immunotoxin may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving fludarabine and cyclophosphamide followed by LMB-2 immunotoxin works in treating patients with Hodgkin's lymphoma.
Biological: LMB-2 immunotoxin
Drug: fludarabine phosphate
Other: pharmacological study
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Hodgkin's Disease After Fludarabine and Cyclophosphamide|
- Feasibility of using fludarabine phosphate and cyclophosphamide to decrease neutralizing antibodies [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
- Response duration [ Designated as safety issue: No ]
- Correlation of serum levels of LMB-2 immunotoxin with toxicity and response [ Designated as safety issue: Yes ]
- Development of neutralizing antibodies and its effect on blood level of LMB-2 immunotoxin and toxicity [ Designated as safety issue: Yes ]
- Correlation of soluble Tac-peptide with treatment response [ Designated as safety issue: No ]
|Study Start Date:||September 2006|
|Study Completion Date:||May 2008|
- 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 patients.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389506
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Robert Kreitman, MD||National Cancer Institute (NCI)|