An interventional study of LMB-2 immunotoxin and cyclophosphamide in Lymphoma, sponsored by National Institutes of Health Clinical Center (CC). Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-16.
Sponsored by National Institutes of Health Clinical Center (CC) · Not applicable, Interventional, and Treatment
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.
OBJECTIVES:
Primary
Secondary
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
Browse Lymphoma studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histopathologically confirmed CD25+ Hodgkin's lymphoma
Meets the following criteria:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
No HIV or hepatitis C positivity
PRIOR CONCURRENT THERAPY:
Feasibility of using fludarabine phosphate and cyclophosphamide to decrease neutralizing antibodies
Response rate
Response duration
Correlation of serum levels of LMB-2 immunotoxin with toxicity and response
Development of neutralizing antibodies and its effect on blood level of LMB-2 immunotoxin and toxicity
Correlation of soluble Tac-peptide with treatment response
This study is withdrawn, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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National Institutes of Health Clinical Center (CC)