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.
Patients will receive each vaccine once only consisting of:
Arm A: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml
intramuscularly (this arm closed 1/2/02).
Arm B: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml
intramuscularly (this arm closed 3/18/03).
Arm C: Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (now replaced with vegetable (VG)
source after 8/31/06 to increase product safety) subcutaneous Tetanus toxoid 0.5 ml
intramuscularly (this arm open 3/18/03).
Subjects ineligible for tetanus may still receive KLH on this protocol. This is especially
true given the national shortage of tetanus vaccines. Subjects will be eligible for tetanus
when it becomes available if there has been no significant change in treatment interventions
or overall health status and it is within 3 months of the KLH vaccine.
- 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
- Pregnant or lactating women. Females of child-bearing potential will be asked to take
a pregnancy test before receiving vaccines.
- Serious intercurrent medical illnesses which would interfere with the ability of the
patient to carry out the follow-up monitoring program.
- Immunization should not be administered during the course of any febrile illness or
- Hypersensitivity to any component of the vaccine, including Thimerosal, a mercury
- The occurrence of any type of neurologic symptoms to tetanus vaccine in th past.
- Patients with a history of seafood allergy are excluded from receiving KLH.
- Subjects who have had tetanus toxoid within the last 7 years are not eligible for
tetanus vaccine component of this protocol.