Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma
Summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-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 advanced or recurrent lymphoma.
Description
OBJECTIVES:
- Determine the safety and tolerability of monoclonal antibody HuM291 in patients with advanced or recurrent CD3+ T-cell lymphomas.
- Evaluate the pharmacokinetics and pharmacodynamics of this treatment regimen in this patient population.
- Determine the response in these patients treated with this regimen.
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody HuM291 IV over 3 hours on days 1-4 in the absence of unacceptable toxicity. Patients achieving a partial response, complete response with recurrence, or stable disease may receive further therapy.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuM291 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed weekly for 1 month and then monthly for 3 months.
PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study.
Study Design
Primary Purpose: Treatment
Conditions
Lymphoma
Intervention
monoclonal antibody HuM291
Location
Stanford University Medical Center
Stanford
California
United States
94305-5408
Status
Completed
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00006009
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:57:32-0400
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Medical and Biotech [MESH] Definitions
Alemtuzumab
An anti-CD52 ANTIGEN monoclonal antibody used for the treatment of certain types of CD52-positive lymphomas (e.g., CHRONIC LYMPHOCYTIC LEUKEMIA; CUTANEOUS T-CELL LYMPHOMA; and T-CELL LYMPHOMA). Its mode of actions include ANTIBODY-DEPENDENT CELL CYTOTOXICITY.
Rituximab
A murine-derived monoclonal antibody and ANTINEOPLASTIC AGENT that binds specifically to the CD20 ANTIGEN and is used in the treatment of LEUKEMIA; LYMPHOMA and RHEUMATOID ARTHRITIS.
Bevacizumab
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Ustekinumab
A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies.
Palivizumab
A humanized monoclonal antibody and ANTIVIRAL AGENT that is used to prevent RESPIRATORY SYNCYTIAL VIRUS INFECTIONS in high risk pediatric patients.
