Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

Lymphoma Clinical Trial

Official title:

Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004101
• Other study ID #: CDR0000067318
• Secondary ID: UIHC-UICC-LW-02N
• Status: Completed
• Phase: Phase 1
• First received: December 10, 1999
• Last updated: February 8, 2013
• Start date: November 1999

Study information

• Verified date: May 2001
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

I. Assess the safety and tolerability of monoclonal antibody Hu1D10 in patients with previously treated non-Hodgkin's lymphoma expressing the antigen recognized by Hu1D10.

II. Determine the maximum tolerated dose of monoclonal antibody Hu1D10 in these patients.

III. Evaluate the pharmacokinetics, compare the pharmacology at different dose levels, and determine the optimal biological dose of this drug in these patients.

IV. Evaluate any antilymphoma effects of this drug in these patients.

OUTLINE: This is a dose escalation, multicenter study.

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.

Patients are followed at 4 weeks, 50 days, and periodically thereafter until disease progression.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• apolizumab

Locations

Country	Name	City	State
United States	Johns Hopkins Oncology Center	Baltimore	Maryland
United States	Biologics Evaluation Section	Bethesda	Maryland
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	New York Presbyterian Hospital - Cornell Campus	New York	New York
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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.