Clinical trial NCT00000105: Vaccination With Tetanus and KLH to Assess Immune Responses.
Official title: Vaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 1999-11-04
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Normal volunteers
* Patients with Cancer (breast, melanoma, hematologic)
* Transplant patients (umbilical cord blood transplant, autologous transplant)
* Patients receiving other cancer vaccines

Brief 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.

Detailed description: 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.

Eligibility 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

Exclusion Criteria:

* 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 acute infection.
* Hypersensitivity to any component of the vaccine, including Thimerosal, a mercury derivative.
* 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.

Primary outcomes:
measure: To assess whether patients can mediate an appropriate immune response KLH
timeFrame: Week 4 post vaccination
Secondary outcomes:
measure: Tetanus Response
timeFrame: Throughout study
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Division of Hematology, Oncology, and Transplantation 420 Delaware St., SE, Box 806 Mayo
state: Minnesota
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Jeffrey Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: