Minneapolis, Minnesota 55455

  • Cancer

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

2002LS032


NCT ID:

NCT00000105


Secondary ID:

MT1999-06


Study Acronym:


Brief Title:

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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Masonic Cancer Center, University of Minnesota


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Replaced by another study.


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

112


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jeffrey Miller, MD
Principal Investigator
Masonic Cancer Center, University of Minnesota

Study Dates

Start Date:July 2002
Completion Date:March 2012
Completion Type:Actual
Primary Completion Date:March 2012
Primary Completion Type:Actual
Verification Date:November 2017
Last Changed Date:November 27, 2017
First Received Date:November 3, 1999

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Tetanus Response
Time Frame:Throughout study
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To assess whether patients can mediate an appropriate immune response KLH
Time Frame:Week 4 post vaccination
Safety Issues:False

Study Interventions

Intervention Type:Biological
Name:Tetanus toxoid
Description:Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.
Arm Name:Arm A: Intracel KLH
Other Name:PUROGENATED®
Intervention Type:Drug
Name:Montanide ISA51
Description:Emulsify the KLH with Montanide ISA-51. The KLH 1 mg vial will be reconstituted in 0.5 mL sterile water. Once solubilized, add 0.6 mL of Montanide ISA to the vial and administered contents subcutaneously.
Arm Name:Arm C: Biosyn KLH with Montanide ISA51
Other Name:Montanide ISA 51 VG
Intervention Type:Biological
Name:Biosyn KLH
Description:Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.
Arm Name:Arm B: Biosyn KLH
Other Name:Immunocyanin
Intervention Type:Biological
Name:Intracel KLH Vaccine
Description:Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly.
Arm Name:Arm A: Intracel KLH
Other Name:KLH BCI-ImmuneActivator(TM)

Study Arms

Study Arm Type:Other
Arm Name:Arm A: Intracel KLH
Description:Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02).
Study Arm Type:Other
Arm Name:Arm B: Biosyn KLH
Description:Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/18/03).
Study Arm Type:Other
Arm Name:Arm C: Biosyn KLH with Montanide ISA51
Description:Biosyn KLH 1000 mcg (1 mg) with Montanide ISA51 (replaced with vegetable (VG) source after 8/31/06) and subcutaneous Tetanus toxoid 0.5 ml intramuscularly.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Masonic Cancer Center, University of Minnesota

Samples and Retentions

Sample Retention:Samples With DNA
Description: analysis of blood samples before and 4 weeks postvaccination
Study Population: - Normal volunteers - Patients with Cancer (breast, melanoma, hematologic) - Transplant patients (umbilical cord blood transplant, autologous transplant) - Patients receiving other cancer vaccines
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

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