Current Clinical Trials in Non-Hodgkin’s Lymphoma

Current Clinical Trials in Non-Hodgkin’s Lymphoma

The non-Hodgkin’s lymphomas (NHL) are the fifth most
common cause of cancer in men and women in the United States, and the fifth and
sixth leading causes of cancer deaths, respectively. Approximately 54,000 new
cases are projected to be diagnosed in the United States this year,[1] 25% to
30% of which are indolent histologies, with the remainder being aggressive

After decades of limited progress in the therapy of these disorders,
therapeutic paradigms have undergone a revolution. This monumental change is
clearly the result of the availability of rituximab (Rituxan), the first
monoclonal antibody approved for the treatment of a human malignancy.[2,3]
However, fewer than half of patients with follicular NHL respond to rituximab,
and the median response duration is about 1 year. Potential means of improving
on this level of activity may be afforded by the new generation of
radioimmunoconjugates, notably ibritumomab tiuxetan (Zevalin), recently approved
by the Food and Drug Administration (FDA), and tositumomab/iodine-131
tositumomab (Bexxar).[4,5]

Other cytokines, such as interleukin-12 (IL-12), may augment the effector
cell mechanisms activated when rituximab binds to the lymphoma cells.[6]
Additional data suggest that bcl-2 antisense can potentiate the activity of

Focus on Targeted Therapies

This month’s Patient Referral Resource in B-cell non-Hodgkin’s lymphomas
makes a resounding point that the current direction of clinical research has
moved beyond minor modifications of the dose and schedule of standard,
nonspecific cytotoxic approaches. The current focus is on specific, targeted
therapies. The rational development of new strategies that integrate multiple
antibodies directed against different antigens, cytokines that enhance the
activity of those antibodies, antisense compounds, and new chemotherapy drugs
with unique mechanisms of action will hopefully increase our ability to cure
these patients.

The Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment
and Diagnosis (DCTD) at the National Cancer Institute (NCI) sponsors a variety
of trials for patients with newly diagnosed non-Hodgkin’s lymphoma using a
wide range of agents and schedules. The list below includes approved and/or
active clinical trials that are currently being sponsored by the CTEP for the
treatment of non-Hodgkin’s lymphoma. Information about these studies can be
obtained from the principal investigator or contacts listed for each trial or
from Bruce Cheson, MD, at CTEP (,

Phase III

Title: Randomized Trial of Patient-Specific Vaccination with
Conjugated Follicular Lymphoma-Derived Idiotype with Local GM-CSF in First
Complete Remission
Protocol Number: NCI-00-C-0050, NCI-9900.v6
Participating Institutions: National Cancer Institute Medicine Branch,
Moffitt Cancer Center and Research Institute, Northwestern University, Duke
University Medical Center, University of Pennsylvania Cancer Center, Bellevue
Hospital Center
Contact: Larry W. Kwak, MD, Bethesda, Maryland, (301) 846-1607; for a complete listing of
study contacts, click here
Latest Information:

Title: Randomized Phase III Study in Low-Grade Lymphoma Comparing
Cyclophosphamide-Fludarabine to Standard Therapy Followed by Maintenance
Anti-CD20 Antibody
Protocol Number: E1496
Participating Institutions: Eastern Cooperative Oncology Group, Cancer
and Leukemia Group B
Contact: Jean McDonald, Coordinator, Brookline, Massachusetts, (617)


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