NCT00024115

Brief Summary

RATIONALE: The BL22 immunotoxin can locate tumor cells and kill them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of the BL22 immunotoxin in treating patients who have non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Trial Health

35
At Risk

Trial Health Score

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

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withdrawn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

First Submitted

Initial submission to the registry

September 13, 2001

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

April 28, 2015

Status Verified

December 1, 2006

First QC Date

September 13, 2001

Last Update Submit

April 27, 2015

Conditions

LeukemiaLymphoma

Keywords

refractory chronic lymphocytic leukemiaB-cell chronic lymphocytic leukemiastage III grade I follicular small cleaved cell lymphomastage III grade II follicular mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage IV grade I follicular small cleaved cell lymphomastage IV grade II follicular mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomarecurrent grade I follicular small cleaved cell lymphomarecurrent grade II follicular mixed cell lymphomarecurrent grade III follicular large cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent adult diffuse small noncleaved cell/Burkitt's lymphomaprolymphocytic leukemiacontiguous stage II grade I follicular small cleaved cell lymphomacontiguous stage II grade II follicular mixed cell lymphomacontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II grade I follicular small cleaved cell lymphomanoncontiguous stage II grade II follicular mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomastage III diffuse small lymphocytic/marginal zone lymphomacontiguous stage II diffuse small lymphocytic/marginal zone lymphomanoncontiguous stage II diffuse small lymphocytic/marginal zone lymphomastage IV diffuse small lymphocytic/marginal zone lymphomarecurrent diffuse small lymphocytic/marginal zone lymphomarecurrent mantle cell lymphoma

Interventions

BL22 immunotoxinDRUG
antibody therapyPROCEDURE
biological response modifier therapyPROCEDURE
immunotoxin therapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed chronic lymphocytic leukemia or prolymphocytic leukemia: * Failed prior standard chemotherapy and treatment is medically indicated as evidenced by the following: * Progressive disease-related symptoms * Progressive cytopenias due to marrow involvement * Progressive or painful splenomegaly or adenopathy * Rapidly increasing lymphocytosis * Autoimmune hemolytic anemia or thrombocytopenia * Increased frequency of infections OR * Confirmed CD22+ B-cell indolent non-Hodgkin's lymphoma * Stages II-IV that have failed at least 1 prior standard therapy and treatment is medically indicated * No patients whose serum neutralizes BL22 or PE38 in tissue culture, due to antitoxin or antimouse-IgG antibodies * No central nervous system disease requiring treatment * If the patient is non-leukemic, the absolute neutrophil count must be greater than 1,000/mm3 and the platelet count greater than 40,000/mm3 PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * More than 6 months Hematopoietic: * See Disease Characteristics Hepatic: * ALT and AST less than 5 times upper limit of normal Renal: * Adequate renal function Pulmonary: * Adequate pulmonary function Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior bone marrow transplantation allowed * At least 3 weeks since prior interferon for malignancy Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior cytotoxic chemotherapy for malignancy Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy for malignancy Surgery: * Not specified Other: * At least 3 weeks since prior retinoids * At least 3 weeks since prior systemic therapy for cancer

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 Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, ProlymphocyticLymphoma, B-Cell, Marginal ZoneLymphoma, Mantle-Cell

Interventions

RFB4(dsFv)-PE38 recombinant immunotoxinImmunization, PassiveAdjuvants, Immunologic

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-Cell

Intervention Hierarchy (Ancestors)

ImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesImmunologic FactorsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Robert Kreitman, MD

    National Cancer Institute (NCI)

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 13, 2001

First Posted

January 27, 2003

Last Updated

April 28, 2015

Record last verified: 2006-12

Locations

US(1)