Status:
WITHDRAWN
Fludarabine and Cyclophosphamide Followed By LMB-2 Immunotoxin in Treating Patients With Hodgkin's Lymphoma
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 dividin...
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 ly...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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 immunotoxin
- PATIENT CHARACTERISTICS:
- 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 following:
- 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 lamivudine
- LVEF ≥ 45%
- DLCO ≥ 50% of normal OR FEV\_1 ≥ 60% of normal
- No active second malignancy requiring treatment
- PRIOR CONCURRENT THERAPY:
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00389506
Start Date
September 1 2006
End Date
May 1 2008
Last Update
March 16 2012
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182