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

Alternate Title

Phase II Study of CCI-779 and Rituximab in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	NCCTG-N038H N038H, NCT00109967

Trial Description

Purpose:

Drugs used in chemotherapy, such as CCI-779, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving CCI-779 together with rituximab may kill more cancer cells.

This phase II trial is studying how well giving CCI-779 together with rituximab works in treating patients with relapsed or refractory mantle cell lymphoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• No CNS 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 CCI-779 once a week for 4 weeks. They will also receive an infusion of rituximab once a week for 4 weeks during course 1 and once in week 1 (a course is 4 weeks long) during courses 3, 5, 7, 9, and 11. Treatment may repeat every 4 weeks for up to 12 courses depending on the tumor's response to treatment.

Patients will be evaluated every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and once a year for 2 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
Scott Kaufmann, MD, PhD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Radha Rao, MD, Protocol co-chair		Ph: 712-252-0088

Registry Information
Official Title		A Phase II Study of CCI-779 in Combination with Rituximab in Patients with Relapsed or Refractory Mantle Cell Lymphoma
Trial Start Date		2005-05-06
Trial Completion Date		2008-05-05 (estimated)
Registered in ClinicalTrials.gov		NCT00109967
Date Submitted to PDQ		2005-03-07
Information Last Verified		2009-03-06
NCI Grant/Contract Number		CA25224

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