Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)
apolizumab
Chronic Disease+29
+ DNA Virus Infections
+ Hematologic Diseases
Treatment Study
Summary
Study start date: November 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.35 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Walter Reed Army Medical Center
Washington D.C., United StatesOpen Walter Reed Army Medical Center in Google MapsUniversity of Iowa Hospitals and Clinics
Iowa City, United StatesJohns Hopkins Oncology Center
Baltimore, United StatesBiologics Evaluation Section
Bethesda, United States