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

Alternate Title

Phase I/II Study of Autologous Dendritic Cell-Adenovirus p53 Vaccine After Standard Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	Other	MCC-13427 MCC-6260, MCC-IRB-0147/NE, MCC-0205538, MCC-12614, NCT00049218

Trial Description

Purpose:

Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Combining vaccine therapy with chemotherapy may kill more tumor cells.

Phase I/II trial to study the effectiveness of chemotherapy followed by adenovirus p53 vaccine therapy in treating patients who have extensive-stage small cell lung cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• At least 4 weeks since steroid therapy
• At least 2 weeks since 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 have white blood cells collected and the dendritic cells will be treated with the adenovirus p 53 in the laboratory to make the vaccine. They will then receive combination chemotherapy over 3 days, and this will be repeated every 3 weeks for up to six courses. Beginning 9 weeks after completing chemotherapy, some patients will receive an injection of the vaccine on days 1, 14, and 28. Three weeks later, some patients will undergo a second collection of white blood cells. Beginning 1 week later, they will receive injections of the vaccine once a month for 3 months. Patients will be evaluated at approximately 4.5 months and every 3 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

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Scott Antonia, MD, PhD, Protocol chair		Ph: 813-972-8400, ext. 2677; 888-663-3488

Registry Information
Official Title		A Phase I-II Trial Using Dendritic Cells Transduced With An Adenoviral Vector Containing The p53 Gene To Immunize Patients With Extensive Stage Small Cell Lung Cancer After Standard Chemotherapy
Trial Start Date		2002-07-30
Registered in ClinicalTrials.gov		NCT00049218
Date Submitted to PDQ		2002-09-03
Information Last Verified		2007-10-11

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