NCT00004101

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 lymphoma

Geographic Reach
1 country

5 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1999

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

May 3, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Last Updated

February 11, 2013

Status Verified

May 1, 2001

Enrollment Period

5.6 years

First QC Date

December 10, 1999

Last Update Submit

February 8, 2013

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 lymphoblastic lymphomarecurrent adult Burkitt lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5.

Biological: apolizumab

Interventions

apolizumabBIOLOGICAL
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed non-Hodgkin's lymphoma in relapse or refractory to prior treatment * At least 50% of malignant cells on biopsy specimen reactive with the 1D10 antibody OR at least 50% of B cells within tumor reactive with 1D10 if extensive T cell infiltrations present * Measurable or evaluable disease * Circulating tumor cells fewer than 5,000/mm3 (in dose escalation phase only) * Not eligible for curative conventional therapy PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0-2 * Life expectancy: At least 3 months * Platelet count at least 75,000/mm3 * Bilirubin less than 2.5 mg/dL * SGOT less than 3 times upper limit of normal * Creatinine less than 2.0 mg/dL * No New York Heart Association class III or IV heart disease * No clinically significant pulmonary disease * No active serious infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior interferon * Concurrent transfusions allowed * At least 4 weeks since prior cytotoxic chemotherapy * No concurrent antineoplastic agents * At least 4 weeks since prior corticosteroids * No concurrent glucocorticoids * At least 4 weeks since prior radiotherapy

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

Sponsors & Collaborators

Study Sites (5)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins Oncology Center

Baltimore, Maryland, 21231, United States

Location

Biologics Evaluation Section

Bethesda, Maryland, 20892-9903, United States

Location

New York Presbyterian Hospital - Cornell Campus

New York, New York, 10021, United States

Location

Related Publications (1)

  • Link BK, Wang H, Byrd JC, et al.: Phase I trial of humanized 1D10 (Hu1D10) monoclonal anitbody class II molecules in patients with relapsed lymphoma. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A86, 2000.

    RESULT

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

apolizumab

Condition Hierarchy (Ancestors)

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

Study Officials

  • Brian Link, MD

    Holden Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

May 3, 2004

Study Start

November 1, 1999

Primary Completion

June 1, 2005

Last Updated

February 11, 2013

Record last verified: 2001-05

Locations

US(5)