Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

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

Alternate Title

Phase I/II Study of Adjuvant Autologous Tumor Cell Vaccine in Patients With Completely Resected Stage II or III Adenocarcinoma of the Colon

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Completed	21 to 85	Pharmaceutical / Industry	INTRACEL-ASI-2002 NCT00016133

Trial Description

Purpose:

Vaccines made from a patient's white blood cells and tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with chemotherapy may kill more tumor cells.

Phase I/II trial to study the effectiveness of vaccine therapy combined with leucovorin and fluorouracil in treating patients who have undergone surgery to completely remove stage II or stage III colon cancer.

Eligibility:

• 21 to 85 years old
• No previous chemotherapy or radiation therapy
• No metastases
• 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:

Beginning within 5 weeks after surgery, patients will receive an injection of vaccine once a week for three injections. Some patients will receive infusions of leucovorin and fluorouracil once a day for 5 days. This chemotherapy will be repeated every 4-5 weeks for up to six courses. All patients will receive a fourth injection of vaccine either 5 months after the third injection or one month after completing chemotherapy. Patients will be evaluated at 3 months and 6 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

Intracel Resources, LLC

Michael G Hanna Jr., PhD, Protocol chair		Ph: 301-668-8400

Registry Information
Official Title		A Non-Randomized Multicenter Phase I/II Study Of Active Specific Immunotherapy In Patients With Stage II and Stage III Colon Cancer
Trial Start Date		2001-03-08
Registered in ClinicalTrials.gov		NCT00016133
Date Submitted to PDQ		2001-03-12
Information Last Verified		2004-07-16

Back to Top