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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 GVAX Pancreatic Cancer Vaccine in Combination With Adjuvant Chemoradiotherapy in Patients With Resected Stage I or II Adenocarcinoma of the Pancreas

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	JHOC-J9988 NCT00084383

Special Category: SPORE trial

Trial Description

Purpose:

Vaccines made from gene-modified pancreatic cancer cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy together with chemotherapy and radiation therapy after surgery may kill any remaining tumor cells.

This phase II trial is studying how well giving vaccine therapy together with adjuvant chemoradiotherapy works in treating patients with resected stage I or stage II adenocarcinoma (cancer) of the pancreas.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No more than 10 weeks since undergoing a Whipple procedure at Johns Hopkins hospital
• No recurrent or metastatic cancer
• More than 1 month since biological therapy, chemotherapy, steroid therapy, or radiation therapy
• 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 the vaccine within 8-10 weeks after undergoing the Whipple procedure. Within 4 weeks after vaccination, patients will receive a 3-week continuous infusion of fluorouracil. One to 2 weeks later, they will undergo radiation therapy once a day and receive a continuous infusion of fluorouracil for 26-28 weeks.

Within 3-5 weeks after completing chemoradiotherapy, patients will receive a 4-week continuous infusion of fluorouracil every 6 weeks for two courses. Within 4-8 weeks after completing chemoradiotherapy, patients will receive an injection of the vaccine in weeks 1, 5, 8, and 29.

Patients will be evaluated every 3 months for 1 year and every 6 months thereafter.

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 Lethally Irradiated Allogeneic Pancreatic Tumor Cells Transfected with the GM-CSF Gene in Combination with Adjuvant Chemoradiotherapy for the Treatment of Adenocarcinoma of the Pancreas
Trial Start Date		2002-01-30
Registered in ClinicalTrials.gov		NCT00084383
Date Submitted to PDQ		2003-10-20
Information Last Verified		2005-06-01
NCI Grant/Contract Number		P30-CA06973, R01-CA88058

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