NCT00004858

Brief Summary

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have recurrent acute lymphoblastic leukemia or non-Hodgkin's lymphoma.

Trial Health

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Trial Health Score

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

Geographic Reach
1 country

3 active sites

Status
unknown

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

March 1, 2000

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
4.1 years until next milestone

First Posted

Study publicly available on registry

April 28, 2004

Completed
Last Updated

September 20, 2013

Status Verified

July 1, 2007

First QC Date

March 7, 2000

Last Update Submit

September 19, 2013

Conditions

LeukemiaLymphoma

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent childhood lymphoblastic lymphomarecurrent adult acute lymphoblastic leukemiarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular 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 Burkitt lymphomarecurrent childhood small noncleaved cell lymphomarecurrent childhood large cell lymphomarecurrent small lymphocytic lymphoma

Interventions

B43-genistein immunoconjugateBIOLOGICAL

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Immunophenotypically proven B-cell acute lymphoblastic leukemia Relapsed at least once following standard induction chemotherapy M1, M2, M3 No CNS disease (including clinical signs of CNS disease) OR Immunophenotypically proven B-cell non-Hodgkin's lymphoma Refractory or resistant disease following up to 3 prior courses of combination chemotherapy Relapsed following bone marrow transplantation No CNS disease No AIDS-related or HTLV-1 associated lymphomas NHL must be one of the following types: Small lymphocytic lymphoma (consistent with chronic lymphoblastic leukemia) Follicular small cleaved cell lymphoma Follicular mixed cell lymphoma Follicular large cell lymphoma Diffuse small cleaved cell lymphoma Diffuse mixed cell lymphoma Diffuse large cell lymphoma Immunoblastic large cell lymphoma Diffuse small noncleaved cell lymphoma Must have greater than 20% CD19 antigen positive blasts in the bone marrow, peripheral blood, or biopsy (for NHL) at first diagnosis or relapse (non-T cell ALL with CD19 positivity pending allowed) Patients who have relapsed after bone marrow transplantation are eligible (no active acute or chronic graft versus host disease involving more than the skin) PATIENT CHARACTERISTICS: Age: 80 and under Performance status: Karnofsky 60-100% Zubrod 0-2 Life expectancy: At least 2 months Hematopoietic: Granulocytopenia, anemia, and/or thrombocytopenia allowed Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT less than 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance or radioisotope GFR at least 70 mL/min Cardiovascular: Shortening fraction at least 27% by echocardiogram OR Cardiac ejection fraction greater than 50% by echocardiogram or gaited radionuclide Pulmonary: No dyspnea at rest No exercise intolerance No clinical evidence of significant restrictive pulmonary disease Pulse oximetry greater than 94% FEV1 or FVC greater than 60% DLCO at least 65 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study HIV negative No uncontrolled diabetes mellitus No other serious uncontrolled medical condition No active uncontrolled infection requiring systemic antibiotics or antifungal medications Prior CNS toxicity no greater than grade 1 PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Recovered from prior biologic therapy Chemotherapy: See Disease Charactertistics At least 2 weeks since prior chemotherapy (4 weeks since nitrosoureas) and recovered Endocrine therapy: At least 1 week since prior high dose steroid therapy and recovered Radiotherapy: Not specified Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (3)

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Parker Hughes Institute

Saint Paul, Minnesota, 55113, United States

Location

Related Publications (1)

  • Uckun FM, Messinger Y, Chen CL, O'Neill K, Myers DE, Goldman F, Hurvitz C, Casper JT, Levine A. Treatment of therapy-refractory B-lineage acute lymphoblastic leukemia with an apoptosis-inducing CD19-directed tyrosine kinase inhibitor. Clin Cancer Res. 1999 Dec;5(12):3906-13.

    PMID: 10632319RESULT

MeSH Terms

Conditions

LeukemiaLymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaDendritic Cell Sarcoma, InterdigitatingLeukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, LymphoidLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsHistiocytic Disorders, MalignantHistiocytosisLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fatih M. Uckun, MD

    Parker Hughes Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2000

First Posted

April 28, 2004

Study Start

March 1, 2000

Last Updated

September 20, 2013

Record last verified: 2007-07

Locations

US(3)