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Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
This study has been completed.
Study NCT00004101   Information provided by National Cancer Institute (NCI)
First Received: December 10, 1999   Last Updated: February 6, 2009   History of Changes

December 10, 1999
February 6, 2009
November 1999
 
 
 
Complete list of historical versions of study NCT00004101 on ClinicalTrials.gov Archive Site
 
 
 
Monoclonal Antibody Therapy in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)

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 non-Hodgkin's lymphoma.

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.

PROJECTED ACCRUAL: A total of 2-35 patients will be accrued for this study over 9-12 months.

Phase I
Interventional
Treatment
Lymphoma
Biological: apolizumab
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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 Hematopoietic: See Disease Characteristics Platelet count at least 75,000/mm3 Hepatic: Bilirubin less than 2.5 mg/dL SGOT less than 3 times upper limit of normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Pulmonary: No clinically significant pulmonary disease Other: No active serious infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior interferon Concurrent transfusions allowed Chemotherapy: At least 4 weeks since prior cytotoxic chemotherapy No concurrent antineoplastic agents Endocrine therapy: At least 4 weeks since prior corticosteroids No concurrent glucocorticoids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: Not specified

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004101
 
CDR0000067318, UIHC-UICC-LW-02, NCI-T99-0019
Holden Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Brian Link, MD Holden Comprehensive Cancer Center
National Cancer Institute (NCI)
May 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP