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

Alternate Title

Pilot Study of Regulatory T-Cell Inhibition With Daclizumab During Antitumor Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly Diagnosed Glioblastoma Multiforme and Therapeutic Temozolomide-Induced Lymphopenia

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic, Treatment	Closed	18 and over	NCI	DUMC-PRO00000581 Pro00000581, SPORE Project 3, NCT00626483

Special Category: SPORE trial

Trial Description

Purpose:

Monoclonal antibodies, such as daclizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Giving these treatments together may kill more tumor cells.

This clinical trial is studying how well daclizumab works in treating patients with newly diagnosed glioblastoma multiforme and temozolomide-caused lymphopenia who are undergoing targeted immunotherapy.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No more than 4 weeks since surgery
• No leptomeningeal cancer
• No previous daclizumab
• No previous surgery to remove lymph nodes in the groin, radiosurgery, implant radiation therapy, or radiolabeled monoclonal antibodies
• No previous donor organ transplant
• 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:

Within 4 weeks after surgery, patient’s blood will be collected and treated in the laboratory. Patients will then undergo stereotactic radiation therapy 5 days a week and receive an infusion of temozolomide 7 days a week for up to 6½ weeks.

Beginning 3 weeks later, patients will receive an infusion of temozolomide on days 1-5. Treatment may repeat every 4 weeks for up to six courses. Beginning in week 3 of course one, patients will receive a vaccination with treated dendritic cells every 2 weeks for three vaccinations. They will also receive infusions of treated white blood cells and daclizumab with the first vaccination.

In week 3 of the second course of temozolomide after finishing radiation therapy, patients will receive radiolabeled dendritic cells. They will also be randomly assigned (have an equal chance) to receive dendritic cells or imiquimod cream applied to the vaccination site 6-24 hours before vaccination. They will also undergo single-photon emission computed tomography.

After finishing treatment, patients will be evaluated every 2 months.

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

Duke Comprehensive Cancer Center

Duane Mitchell, MD, PhD, Protocol chair		Ph: 919-684-9041

Registry Information
Official Title		REGULATory T-Cell Inhibition with Daclizumab (Zenapax®) during Recovery from Therapeutic Temozolomide-induced Lymphopenia during Antitumor Immunotherapy Targeted Against Cytomegalovirus in Patients with Newly-Diagnosed Glioblastoma Multiforme [REGULATe]
Trial Start Date		2007-03-21
Trial Completion Date		2009-03-21 (estimated)
Registered in ClinicalTrials.gov		NCT00626483
Date Submitted to PDQ		2008-02-22
Information Last Verified		2008-12-21
NCI Grant/Contract Number		CA108786, CA14236

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