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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 Monoclonal Antibody 105AD7 Anti-Idiotype Vaccine and ONYCR1, ONYCR2, and ONYCR3 Allogeneic Adenocarcinoma Cell-Based Vaccines in Patients With Locally Advanced or Metastatic Adenocarcinoma of the Colon or Rectum

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	Pharmaceutical / Industry	ONYVAX-SGCRO01 NCI-V00-1599, NCT00007826

Trial Description

Purpose:

Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from cancer cells may make the body build an immune response to kill colorectal tumor cells.

Phase I/II trial to study the effectiveness of monoclonal antibody therapy and/or vaccine therapy in treating patients who have locally advanced or metastatic colorectal cancer.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Received previous chemotherapy for metastatic cancer
• At least 1 month since biological therapy, chemotherapy, or steroid therapy
• At least 6 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 be assigned to one of three groups. Patients in group one will receive injections of the monoclonal antibody alone. Patients in group two will receive vaccine therapy alone. Patients in group three will receive monoclonal antibody therapy combined with vaccine therapy. In all groups, patients will receive injections once a week in weeks 1, 2, 4, and 6, and then once a month for up to 1 year. Patients will be evaluated every 3 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

Onyvax Limited at St. George's Hospital Medical School

Fiona Lofts, MD, Protocol chair		Ph: 44-20-8725-0231

Registry Information
Official Title		A Phase I/II Trial of an Allogeneic Cell Based Vaccine and an Anti-Idiotypic Antibody Vaccine Approach for Metastatic Adenocarcinoma of the Colon or Rectum
Trial Start Date		2000-04-25
Registered in ClinicalTrials.gov		NCT00007826
Date Submitted to PDQ		2000-06-09
Information Last Verified		2005-02-09

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