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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 an Allogeneic Sargramostim Plasmid DNA Pancreatic Tumor Cell Vaccine in Patients With Surgically Resected Pancreatic Adenocarcinoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Natural history/Epidemiology, Treatment	Closed	18 and over	Other	JHOC-J0619 J0619, JHOC-SKCCC-J0619, JHOC-00002731, JHOC-GT0604170201, JHOC-0607-799, NCT00389610

Trial Description

Purpose:

Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of pancreatic cancer.

This phase II trial is studying the side effects and how well vaccine therapy works in treating patients with pancreatic cancer that has been removed by surgery.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Stage I, stage II, or stage III pancreatic cancer
• No recurrent cancer
• At least 4 weeks since treatment for cancer or steroid therapy
• At least 6 months since tumor cell vaccine while enrolled on clinical trial SKCC-J9617 or SKCC-J9988
• 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:

Some patients will receive an injection of a booster vaccine every 6 months for as long as benefit is shown. Other patients will receive an injection of a vaccine once a month for 3 months. They will then receive an injection of a booster vaccine every 6 months for as long as benefit is shown.

Patients will complete questionnaires about quality of life, hope, trust, pain, fatigue, anorexia, and mood in weeks 1 and 5.

After finishing treatment, patients will be evaluated in week 5 and once a year for 15 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

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Daniel Laheru, MD, Principal investigator		Ph: 410-955-8974

Registry Information
Official Title		A Safety and Efficacy Trial of Vaccine Boosting with Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected with the GM-CSF Gene for the Treatment of Pancreatic Adenocarcinoma
Trial Start Date		2006-09-08
Trial Completion Date		2009-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00389610
Date Submitted to PDQ		2006-09-08
Information Last Verified		2009-03-11
NCI Grant/Contract Number		CA06973

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