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Vaccination With Tetanus and KLH to Assess Immune Responses.
This study is currently recruiting participants.
Verified by Masonic Cancer Center, University of Minnesota, April 2009
First Received: November 3, 1999   Last Updated: April 21, 2009   History of Changes
Sponsored by: Masonic Cancer Center, University of Minnesota
Information provided by: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00000105
  Purpose

The purpose of this study is to learn how the immune system works in response to vaccines. We will give the vaccines to subjects who have cancer but have not had treatment, and to patients who have had chemotherapy or stem cell transplant. Some patients will get vaccines while they are on treatments which boost the immune system (like the immune stimulating drug interleukin-2 or IL-2). Although we have safely treated many patients with immune boosting drugs, we do not yet know if they improve the body's immune system to respond better to a vaccine. Some healthy volunteers will also be given the vaccines in order to serve as control subjects to get a good measure of the normal immune response. We will compare the patients and the healthy volunteers to study how their immune systems respond to the vaccines.

There are several different types of white cells in the blood. We are interested in immune cells in the blood called T-cells. These T-cells detect foreign substances in the body (like viruses and cancer cells). We are trying to learn more about how the body fights these foreign substances.

Our goal is to develop cancer vaccines which would teach T-cells to detect and kill cancer cells better. We know that in healthy people the immune system effectively protects against recurrent virus infection. For example, that is why people only get "mono" (mononucleosis) once under normal circumstances. When the body is infected with the "mono" virus, the immune system remembers and prevents further infection. We are trying to use the immune system to prevent cancer relapse. To test this, we will give two vaccines which have been used to measure these immune responses. Blood samples will be studied from cancer patients and will be compared to similar samples from normal subjects.


Condition Intervention
Cancer
Biological: Tetanus and KLH

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Vaccination With Tetanus Toxoid and Keyhold Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Estimated Enrollment: 150
Study Start Date: July 2002
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients must have a diagnosis of cancer of any histologic type.
  • Patients must have a Karnofsky performance status great or equal to 70%.
  • Patients must have an expected survival for at least four months.
  • Normal healthy volunteers to serve as control for this study.
  • All patients must sign informed consent approved by the Committee on the Use of Human Subjects at the University of Minnesota
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000105

Contacts
Contact: Dr. Jeffrey Miller 1-612-625-3636

Locations
United States, Minnesota
Division of Hematology, Oncology, and Transplantation 420 Delaware St., SE, Box 806 Mayo Recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, Blood and Marrow Transplantation ( Jeffrey Miller, M.D. )
Study ID Numbers: MT1999-06, M01RR00400, NCRR-M01RR00400-0626
Study First Received: November 3, 1999
Last Updated: April 21, 2009
ClinicalTrials.gov Identifier: NCT00000105     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Tetanus

ClinicalTrials.gov processed this record on July 02, 2009