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

Alternate Title

Phase I Study of Intratumoral PV701 in Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	UCCRC-12157B 1614, NCI-1614, NCT00081211

Trial Description

Purpose:

Vaccines made from a specially-modified virus such as PV701 may make the body build an immune response to kill tumor cells while leaving normal cells undamaged. Injecting PV701 directly into the tumor may cause a stronger immune response and kill more tumor cells.

Phase I trial to study the effectiveness of intratumoral (in the tumor) PV701 in treating patients who have advanced or recurrent unresectable squamous cell carcinoma (cancer) of the head and neck.

Eligibility:

• At least 18 years old
• No brain metastases
• More than 4 weeks since chemotherapy, radiation therapy, or 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 receive an injection of PV701 directly into the tumor once a week for 3 weeks. Treatment may be repeated every 6 weeks for as long as benefit is shown.

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

University of Chicago Cancer Research Center

David Gustin, MD, Protocol chair(Contact information may not be current)		Ph: 773-834-8634; 888-824-0200

Registry Information
Official Title		A Phase I Study Of PV701 In Patients With Head And Neck Squamous Cell Carcinoma
Registered in ClinicalTrials.gov		NCT00081211
Date Submitted to PDQ		2004-02-27
Information Last Verified		2004-05-25
NCI Grant/Contract Number		P30-CA14599, N01-CM17102

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