Fludarabine and Cyclophosphamide Followed By LMB-2 Immunotoxin in Treating Patients With Hodgkin's Lymphoma

Not Applicable

Withdrawn

• Conditions: Lymphoma

• Registration Number: NCT00389506
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

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

Secondary

* 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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-18
• Study First Submitted QC: 2006-10-18
• Study First Posted: 2006-10-19
• Study Completion: 2008-05
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of using fludarabine phosphate and cyclophosphamide to decrease neutralizing antibodies

Secondary Outcome Measures

Name	Time	Method
Development of neutralizing antibodies and its effect on blood level of LMB-2 immunotoxin and toxicity
Correlation of soluble Tac-peptide with treatment response
Response rate
Correlation of serum levels of LMB-2 immunotoxin with toxicity and response
Response duration

Trial Locations

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States