NCT00389506WithdrawnNot Applicable
A Pilot Study of Anti-Tac(Fv)-PE38 (LMB-2) Immunotoxin for Treatment of CD25 Positive Hodgkin's Disease After Fludarabine and Cyclophosphamide
National Institutes of Health Clinical Center (CC)1 site in 1 countryStarted: September 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Feasibility of using fludarabine phosphate and cyclophosphamide to decrease neutralizing antibodies
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility of using fludarabine phosphate and cyclophosphamide to decrease neutralizing antibodies
Secondary Outcomes
- Response rate
- Development of neutralizing antibodies and its effect on blood level of LMB-2 immunotoxin and toxicity
- Correlation of soluble Tac-peptide with treatment response
- Correlation of serum levels of LMB-2 immunotoxin with toxicity and response
- Response duration
Investigators
Study Sites (1)
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