Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Rituximab and Denileukin Diftitox in Patients With Previously Untreated Stage III or IV Follicular B-Cell Non-Hodgkin's Lymphoma

Basic Trial Information

Trial Description

Purpose:

Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Combinations of biological substances in denileukin diftitox may be able to carry cancer-killing substances directly to cancer cells. Giving rituximab together with denileukin diftitox may kill more cancer cells.

This phase II trial is studying how well giving rituximab together with denileukin diftitox works in treating patients with previously untreated stage III or stage IV follicular B-cell non-Hodgkin's lymphoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Grade 1 or grade 2 follicular lymphoma
• Measurable disease
• No CNS lymphoma
• No previous chemotherapy, biological therapy, vaccine therapy, or radiation therapy for non-Hodgkin’s lymphoma
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will receive an infusion of rituximab once a week for 4 weeks. They will also receive a 15- to 60-minute infusion of denileukin diftitox on days 1-5. Treatment with denileukin diftitox may repeat every three weeks for up to four courses.

Patients will undergo blood sample collection for laboratory studies at the beginning of the study; on day 1 of courses two, three, and four; and 1 month and 4 months after finishing treatment.

After finishing treatment, patients will be evaluated periodically for up to 5 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Stephen Ansell, MD, PhD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Thomas Witzig, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Peter Silberstein, MD, Protocol co-chair		Ph: 402-280-4364 Email: psilberstein@creighton.edu

Registry Information
Official Title		A Phase II Clinical Trial of Denileukin Diftitox in Combination with Rituximab in Previously Untreated Follicular B-Cell Non-Hodgkin's Lymphoma
Trial Start Date		2008-04-04
Trial Completion Date		2011-03-15
Registered in ClinicalTrials.gov		NCT00460109
Date Submitted to PDQ		2007-03-13
Information Last Verified		2010-04-10
NCI Grant/Contract Number		CA25224

Back to Top