NCT00389506

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2006

Shorter than P25 for not_applicable lymphoma

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2006

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

First QC Date

October 18, 2006

Last Update Submit

March 14, 2012

Conditions

Lymphoma

Keywords

stage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

  • Feasibility of using fludarabine phosphate and cyclophosphamide to decrease neutralizing antibodies

Secondary Outcomes (5)

  • 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

Interventions

LMB-2 immunotoxinBIOLOGICAL
cyclophosphamideDRUG
fludarabine phosphateDRUG
pharmacological studyOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

LymphomaHodgkin Disease

Interventions

B3(Fv)-PE38KDEL recombinant immunotoxinCyclophosphamidefludarabine phosphate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Robert Kreitman, MD

    National Cancer Institute (NCI)

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 2006

First Posted

October 19, 2006

Study Start

September 1, 2006

Study Completion

May 1, 2008

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

US(1)