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NCT00000105 · ClinicalTrials.gov registry record
Vaccination With Tetanus and KLH to Assess Immune Responses.
A clinical trial, sponsored by Masonic Cancer Center, University of Minnesota.
- Terminated
- Registry status
- 112
- Enrollment target
NCT00000105: Clinical Trial study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT00000105 is a clinical trial that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 112 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000105 was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.
- TERMINATED
- Registry status
- 112 participants
- Enrollment target
Study Summary
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.
Interventions
- BIOLOGICAL Tetanus toxoid
- BIOLOGICAL Intracel KLH Vaccine
- BIOLOGICAL Biosyn KLH
- DRUG Montanide ISA51
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2002-07 |
| Est. Completion | 2012-03 |
Why NCT00000105 stopped before completion
NCT00000105 is an observational study that tracks outcomes without assigning an intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 4 interventions - of which Tetanus toxoid is the first listed.
NCT00000105 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000105 about?
NCT00000105 is a clinical study titled "Vaccination With Tetanus and KLH to Assess Immune Responses.". 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...
What is the current status of trial NCT00000105?
This trial is currently terminated. The enrollment target is 112 participants. The study started on 2002-07. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00000105?
The interventions under investigation include: Tetanus toxoid (BIOLOGICAL), Intracel KLH Vaccine (BIOLOGICAL), Biosyn KLH (BIOLOGICAL), Montanide ISA51 (DRUG).
Who is sponsoring clinical trial NCT00000105?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
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