CancerNCT00000105
Vaccination With Tetanus and KLH to Assess Immune Responses.
An observational study of Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Intracel KLH Vaccine, Biosyn KLH and Montanide ISA51
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Normal volunteers * Patients with Cancer (breast, melanoma, hematologic) * Transplant patients (umbilical cord blood transplant, autologous transplant) * Patients receiving other cancer vaccines
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Hematology, Oncology, and Transplantation 420 Delaware St., SE, Box 806 Mayo
Minneapolis, Minnesota, 55455
About this study
Official title: Vaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific 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 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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Intracel KLH Vaccine, Biosyn KLH, Montanide ISA51, Tetanus toxoid
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracel KLH VaccineBiological
Also called KLH BCI-ImmuneActivator(TM), IntraCel
Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly.
Biosyn KLHBiological
Also called Immunocyanin, IMMUCOTHEL®, VACMUNE®
Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly.
Montanide ISA51Drug
Also called Montanide ISA 51 VG
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.
Tetanus toxoidBiological
Also called PUROGENATED®
Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Intracel KLH | Intracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02). Receives: Biological: Intracel KLH Vaccine; Biological: Tetanus toxoid | |
| Arm B: Biosyn KLH | Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/18/03). Receives: Biological: Biosyn KLH; Biological: Tetanus toxoid | |
| Arm C: Biosyn KLH with Montanide ISA51 | 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. Receives: Biological: Biosyn KLH; Drug: Montanide ISA51; Biological: Tetanus toxoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether patients can mediate an appropriate immune response KLH
Measured: Week 4 post vaccination
Secondary outcomes (1)
Tetanus Response
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJul 2002
- Primary completionMar 2012
- Study completionMar 2012
Why it stopped: Replaced by another study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Miller, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000105
- Sponsor's protocol ID
- 2002LS032
- Other IDs
- MT1999-06
- Status last verified
- Nov 2017
- First submitted
- 3 Nov 1999
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination With Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses
- ClinicalTrials.gov ID
- NCT00000105
- Acronym / sponsor ID
- 2002LS032
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Replaced by another study.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2002
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Intracel KLH | – | Biological: Intracel KLH Vaccine, Biological: Tetanus toxoidIntracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly (this arm closed 1/2/02). |
| Arm B: Biosyn KLH | – | Biological: Biosyn KLH, Biological: Tetanus toxoidBiosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly (this arm closed 3/18/03). |
| Arm C: Biosyn KLH with Montanide ISA51 | – | Biological: Biosyn KLH, Drug: Montanide ISA51, Biological: Tetanus toxoidBiosyn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Normal volunteers * Patients with Cancer (breast, melanoma, hematologic) * Transplant patients (umbilical cord blood transplant, autologous transplant) * Patients receiving other cancer vaccines
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracel KLH VaccineAlso: KLH BCI-ImmuneActivator(TM), IntraCelIntracel KLH 1000 mcg (1 mg) without adjuvant, subcutaneous Tetanus Toxoid 0.5 ml intramuscularly. | Biological | Arm A: Intracel KLH |
| Biosyn KLHAlso: Immunocyanin, IMMUCOTHEL®, VACMUNE®Biosyn KLH 1000 mcg (1 mg) without adjuvant, subcutaneous tetanus toxoid 0.5 ml intramuscularly. | Biological | Arm B: Biosyn KLH, Arm C: Biosyn KLH with Montanide ISA51 |
| Montanide ISA51Also: Montanide ISA 51 VGEmulsify 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. | Drug | Arm C: Biosyn KLH with Montanide ISA51 |
| Tetanus toxoidAlso: PUROGENATED®Tetanus Toxoid Adsorbed, Aluminum Phosphate Adsorbed, PUROGENATED® (TT), is a sterile preparation of refined tetanus toxoid for intramuscular use only. | Biological | Arm A: Intracel KLH, Arm B: Biosyn KLH, Arm C: Biosyn KLH with Montanide ISA51 |
Primary outcome
To assess whether patients can mediate an appropriate immune response KLH
Time frame: Week 4 post vaccination
1 secondary outcome
Tetanus Response
Time frame: Throughout study
Results and safety
The study was stopped early (reason given: Replaced by another study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Miller, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Replaced by another study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess whether patients can mediate an appropriate immune response KLH (time frame: Week 4 post vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.