NCT00007956

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 or refractory lymphoma.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
completed

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

November 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

April 30, 2015

Status Verified

February 1, 2002

First QC Date

January 6, 2001

Last Update Submit

April 29, 2015

Conditions

Lymphoma

Keywords

recurrent 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 Burkitt lymphomarecurrent mantle cell lymphomarecurrent small lymphocytic lymphoma

Interventions

monoclonal antibody mono-dgA-RFB4BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent or refractory B-cell lymphoma after at least 1 standard chemotherapy regimen * Low, intermediate, or high grade * CD22 antigen on at least 30% of tumor cells by flow cytometry * No lymphoblastic lymphoma, B-cell chronic lymphocytic leukemia, B-cell or pre-B-cell acute lymphocytic leukemia, or hairy cell leukemia * Measurable disease * Positive bone marrow not considered measurable * Circulating tumor cells in peripheral blood considered measurable * No CNS disease (leptomeningeal or parenchymal) * No lymphomatous or infectious pulmonary parenchymal disease * No baseline/pleural effusion * Ineligible for or refused autologous or allogeneic bone marrow transplantation NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Platelet count greater than 50,000/mm\^3 * Absolute granulocyte count greater than 750/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL * SGPT less than 2 times upper limit of normal * Albumin greater than 75% lower limit of normal Renal: * Creatinine no greater than 1.4 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * Ejection fraction greater than 40% by MUGA or echocardiogram Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No human anti-mouse antibody (HAMA) levels greater than 1 microgram/mL * No condition that may require stenting of ureters, stabilization of impending pathological fractures, or relief of airway, bowel, or biliary tract obstruction * No other concurrent illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics * At least 2 weeks since prior chemotherapy and recovered * No concurrent chemotherapy Endocrine therapy: * No concurrent corticosteroids unless receiving stable maintenance dose prior to therapy Radiotherapy: * No prior radiotherapy * No concurrent radiotherapy Surgery: * Not specified Other: * No other concurrent investigational agents

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

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Edward A. Sausville, MD, PhD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

January 6, 2001

First Posted

January 27, 2003

Study Start

November 1, 2000

Last Updated

April 30, 2015

Record last verified: 2002-02

Locations

US(2)