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WithdrawnNCT00389506Updated Mar 16, 2012

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

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 Withdrawn at 1 site in United States.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

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lymphoma

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Keywords

  • stage II adult Hodgkin lymphoma
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • recurrent adult Hodgkin lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

Browse Lymphoma studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Enrollment
0 participants (actual)

Interventions

  • BiologicalLMB-2 immunotoxin
  • Drugcyclophosphamide
  • Drugfludarabine phosphate
  • Otherpharmacological study
06

What researchers measure

Primary outcomes

  1. Feasibility of using fludarabine phosphate and cyclophosphamide to decrease neutralizing antibodies

Secondary outcomes

  1. Response rate

  2. Response duration

  3. Correlation of serum levels of LMB-2 immunotoxin with toxicity and response

  4. Development of neutralizing antibodies and its effect on blood level of LMB-2 immunotoxin and toxicity

  5. Correlation of soluble Tac-peptide with treatment response

07

Study locations

1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
    Bethesda, Maryland 20892-1182, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00389506
Lead sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
First posted
Oct 19, 2006
Start date
Sep 2006
Completion
May 2008
Last update
Mar 16, 2012

Study contacts

Robert Kreitman, MD
study chair · National Cancer Institute (NCI)
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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