Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

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

Alternate Title

Phase I/II Study of Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab With and Without Filgrastim (G-CSF) and Interleukin-11 in Patients With Relapsed or Refractory Low-Grade or Follicular CD20+ Non-Hodgkin's Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	NCI	MAYO-MC998C NCI-312, NCT00012298

Trial Description

Purpose:

Radiolabeled monoclonal antibodies can locate cancer cells and deliver cancer-killing substances to them without harming normal cells. Biological therapies such as filgrastim and interleukin-11 use different ways to stimulate the immune system and stop cancer cells from growing.

Phase I/II trial to study the effectiveness of combining radiolabeled monoclonal antibody therapy and rituximab with and without filgrastim and interleukin-11 in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• No CNS lymphoma or HIV - or AIDS -related lymphoma
• More than 4 weeks since surgery (other than diagnostic surgery)
• 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 have their stem cells collected. Patients will then receive an infusion of a radiolabeled monoclonal antibody on day 1, rituximab on days 1 and 8, and a second radiolabeled monoclonal antibody on day 8. Treatment may be repeated 6-9 months later. Patients will also receive injections of filgrastim and interleukin-11 once a day until blood counts return to normal. Patients may then undergo stem cell transplantation. 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

Mayo Clinic Cancer Center

Thomas Witzig, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Gregory Wiseman, MD, Protocol co-chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		Phase I Study of Two Sequential Doses of IDEC-Y2B8 in Patients with Relapsed Low Grade and Follicular Non-Hodgkin's Lymphoma
Trial Start Date		2001-04-20
Trial Completion Date		2011-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00012298
Date Submitted to PDQ		2001-01-29
Information Last Verified		2009-08-02
NCI Grant/Contract Number		CA15083

Back to Top