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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, July 2009
First Received: November 3, 1999   Last Updated: July 31, 2009   History of Changes
Sponsor: 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:

Primary Outcome Measures:
  • To assess whether patients can mediate an appropriate immune response KLH [ Time Frame: Week 4 post vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tetanus Response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2002
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm A: No Intervention
Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoic 0.5 ml intramuscularly (this arm closed 1/2/02).
Biological: Tetanus and KLH

A: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02).

B: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/16/03).

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 3/16/03).

Arm B: No Intervention
Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/16/03).
Biological: Tetanus and KLH

A: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02).

B: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/16/03).

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 3/16/03).

Arm C: No Intervention
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 3/16/03).
Biological: Tetanus and KLH

A: Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02).

B: Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/16/03).

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 3/16/03).


Detailed Description:

Patients will receive each vaccines 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 3/16/03).

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 3/16/03).

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

Ages Eligible for Study:   18 Years and older
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

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 Thimersal, 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.
  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
Investigators
Principal Investigator: Jeffrey Miller, MD 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, UMN-2002LS032
Study First Received: November 3, 1999
Last Updated: July 31, 2009
ClinicalTrials.gov Identifier: NCT00000105     History of Changes
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 27, 2009