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

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.


Condition Intervention Phase
Lymphoma
Biological: apolizumab
Phase I

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Apolizumab Immunoglobulins Globulin, Immune
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1999
Detailed 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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004101

Locations
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
Biologics Evaluation Section
Bethesda, Maryland, United States, 20892-9903
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21231
United States, New York
New York Presbyterian Hospital - Cornell Campus
New York, New York, United States, 10021
Sponsors and Collaborators
Holden Comprehensive Cancer Center
Investigators
Study Chair: Brian Link, MD Holden Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
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.

Study ID Numbers: CDR0000067318, UIHC-UICC-LW-02, NCI-T99-0019
Study First Received: December 10, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004101     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult Burkitt lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
splenic marginal zone lymphoma

Study placed in the following topic categories:
Immunologic Factors
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Mantle Cell Lymphoma
Follicular Lymphoma
Lymphoblastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
Antibodies, Monoclonal
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Immunoblastic
Leukemia, B-cell, Chronic
Lymphoma, Large-cell
Lymphoma
Immunoglobulins
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Recurrence
Lymphatic Diseases
Burkitt's Lymphoma
Chronic Lymphocytic Leukemia
Antibodies
B-cell Lymphomas
Burkitt Lymphoma
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin

Additional relevant MeSH terms:
Antibodies, Monoclonal
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009