Prostate CancerPhase 1NCT00698711
Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21
A Phase 1 study testing MUC-2-KLH in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this research is to help us study a vaccine treatment for patients with prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections and other foreign substances. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MUC-2-KLH
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1997to Mar 2009
- Phase
- Phase 1
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with prostate cancer that is histologically confirmed by the Department of Pathology at MSKCC will be considered if they show progression of disease based on biochemical parameters. Patients with radiographic evidence of disease are not eligible.
- Hormonal status will be recorded on the basis of serum testosterone levels.
- Patients who have progressed after primary therapy to include surgery or radiation (with or without neo-adjuvant androgen ablation), or intermittent hormonal treatment who have non-castrate levels of testosterone (>50 ng/ml). Patients with soft tissue and/or bone disease or patients who are androgen- independent with no evidence of radiographic disease are not eligible. Those patients who are symptomatic or who are anticipated to develop symptoms within 6 months of entry will be excluded.
- Patients should have no change in their hormone therapies (with the exception of therapies needed to maintain castrate levels of testosterone), including prednisone or dexamethasone within two weeks prior to entry into study.
- Patients must have evaluable disease (by serial changes in PSA).
- Karnofsky performance status >60%.
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- Patients must have adequate organ function as defined by:
- WBC > or = to 3500/mm3 platelet count > or = to 100,000 mm3.
- Bilirubin < or = 2.0 rag/100 ml or SGOT <3.0 X's the upper limit of normal.
- Creatinine < or = 2.0 mg/100 ml or creatinine clearance > or = 40 cc/min.
- Patients must have recovered from the toxicity of any prior therapy, and not received chemotherapy or radiation therapy for at least 4 weeks prior to entry into the trial.
- No history of an active secondary malignancy within the prior five years except for nonmelanoma skin cancer.
- Patients must be at least 18 years of age.
- Patients who have previously received suramin, may be treated if they have been off this drug for at least 8 weeks and/or ha ve a documented plasma concentration below 50 mg/ml. For these patients, replacement doses of hydrocortisone are permitted.
- Patients must sign informed consent.
- Registration to IRB Protocol 90-40 (Correlative studies in human prostate cancer).
Who cannot join
- Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
- Active CNS or epidural tumor.
- An infection requiring antibiotic treatment.
- Narcotic dependent pain.
- Anticipated survival of less than 6 months.
- Positive stool guaiac excluding hemorrhoids or history of documented radiation induced proctitis.
- Allergy to seafood.
- Patients with radiographic evidence of metastatic disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Comparing MUC-2-KLH Doses
The purpose of this research is to help us study a vaccine treatment for patients with prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections and other foreign substances. The immune system is made up of many different types of cells, which fight infection and disease in your body. A vaccine may stimulate the immune system to destroy the cancer cells. It may also help to slow the growth of the cancer. The vaccine is a solution given as an injection given into or under the skin. It is made up of several parts. The first part is MUC-2, a protein present in many cancers, especially prostate cancer. MUC-2 is attached to a material called KLH or keyhole limpet hemocyanin. KLH is purified from a snail- like marine mollusk called a keyhole limpet and has been used for many years to boost immune responses in animals and in people. Attaching MUC-2 to KLH helps the immune system react to MUC-2. The mixture of MUC-2 attached to KLH is in turn mixed with a material called QS21, from the bark of a tree, which also helps the immune system to make more cancer- fighting cells. A vaccine like the one you will receive has been given to laboratory animals and been shown to produce an immune response in these animals.
- Conditions
- Prostate Cancer
- Being tested
- MUC-2-KLH
- Keywords
- Prostate cancer, MUC-2-KLH, QS 21
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MUC-2-KLHBiological
The MUC-2-KLH conjugate will be administered subcutaneously to random sites on the upper arm and upper leg at weekly intervals for 3 weeks. This will be followed by a 4 week break and then a fourth vaccination during week 7, and 3 months later during week 19. Booster vaccinations may be given at or after week 50 and 100, and every 6 months thereafter to select patients who show no evidence of radiographic disease progression.
After 5 patients have been enrolled and completed two vaccinations without Grade II or greater toxicity, we will proceed to the next higher dose level. No dose escalations will be performed in the same patient.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Three groups of 5 patients enrolled sequentially comprised from will receive MUC-2-KLH vaccines at the following g amounts of MUC-2-KLH per vaccination.
10 + 100 μg QS21 30 + 100 μg QS21 3 + 100 μg QS21 Receives: Biological: MUC-2-KLH |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine an optimal dose of the MUC-2-KLH conjugate plus the immunological adjuvant QS21 in patient with prostate cancer that Induces an antibody response to MUC-2. and induces helper T and/or cytotoxic T cell response against MUC -2.
Measured: conclusion of study
To determine the safety of immunization with MUC-2-KLH conjugate prepared using an MBS heterobifunctional linker plus QS21.
Measured: conclusion of study
To determine the effect of MUC-2-KLH dose on the T cell response against MUC-2 and by skin testing.
Measured: conclusion of study
Secondary outcomes (3)
To assess post-immunization changes in prostate specific antigen levels and other objective parameters or disease (radionuclide bone scan and/or measurable disease if present).
Measured: conclusion of study
To monitor changes in serum CASA levels prior to and following treatment.
Measured: conclusion of study
To monitor sequentially, the peripheral blood for the presence of PSA mRNA in circulating cells using a PCR based assay.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startNov 1997
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Slovin, MD,PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698711
- Sponsor's protocol ID
- 97-122
- Status last verified
- Jan 2012
- First submitted
- 13 Jun 2008
- Last updated
- 31 Jan 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination of Prostate Cancer Patients With MUC-2-KLH Conjugate Plus the Immunological Adjuvant QS21: A Trial Comparing MUC-2-KLH Doses
- ClinicalTrials.gov ID
- NCT00698711
- Acronym / sponsor ID
- 97-122
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, MUC-2-KLH, QS 21
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Nov 1997
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Jun 2008 (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 research is to help us study a vaccine treatment for patients with prostate cancer. A vaccine is a medicine that teaches the body to destroy harmful infections and other foreign substances. The immune system is made up of many different types of cells, which fight infection and disease in your body. A vaccine may stimulate the immune system to destroy the cancer cells. It may also help to slow the growth of the cancer. The vaccine is a solution given as an injection given into or under the skin. It is made up of several parts. The first part is MUC-2, a protein present in many cancers, especially prostate cancer. MUC-2 is attached to a material called KLH or keyhole limpet hemocyanin. KLH is purified from a snail- like marine mollusk called a keyhole limpet and has been used for many years to boost immune responses in animals and in people. Attaching MUC-2 to KLH helps the immune system react to MUC-2. The mixture of MUC-2 attached to KLH is in turn mixed with a material called QS21, from the bark of a tree, which also helps the immune system to make more cancer- fighting cells. A vaccine like the one you will receive has been given to laboratory animals and been shown to produce an immune response in these animals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: MUC-2-KLHThree groups of 5 patients enrolled sequentially comprised from will receive MUC-2-KLH vaccines at the following g amounts of MUC-2-KLH per vaccination. 10 + 100 μg QS21 30 + 100 μg QS21 3 + 100 μg QS21 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with prostate cancer that is histologically confirmed by the Department of Pathology at MSKCC will be considered if they show progression of disease based on biochemical parameters. Patients with radiographic evidence of disease are not eligible.
- Hormonal status will be recorded on the basis of serum testosterone levels.
- Patients who have progressed after primary therapy to include surgery or radiation (with or without neo-adjuvant androgen ablation), or intermittent hormonal treatment who have non-castrate levels of testosterone (>50 ng/ml). Patients with soft tissue and/or bone disease or patients who are androgen- independent with no evidence of radiographic disease are not eligible. Those patients who are symptomatic or who are anticipated to develop symptoms within 6 months of entry will be excluded.
- Patients should have no change in their hormone therapies (with the exception of therapies needed to maintain castrate levels of testosterone), including prednisone or dexamethasone within two weeks prior to entry into study.
- Patients must have evaluable disease (by serial changes in PSA).
Key exclusion criteria (8 listed)
- Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
- Active CNS or epidural tumor.
- An infection requiring antibiotic treatment.
- Narcotic dependent pain.
- Anticipated survival of less than 6 months.
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 |
|---|---|---|
| MUC-2-KLHThe MUC-2-KLH conjugate will be administered subcutaneously to random sites on the upper arm and upper leg at weekly intervals for 3 weeks. This will be followed by a 4 week break and then a fourth vaccination during week 7, and 3 months later during week 19. Booster vaccinations may be given at or after week 50 and 100, and every 6 months thereafter to select patients who show no evidence of radiographic disease progression. After 5 patients have been enrolled and completed two vaccinations without Grade II or greater toxicity, we will proceed to the next higher dose level. No dose escalations will be performed in the same patient. | Biological | 1 |
Primary outcome
To determine an optimal dose of the MUC-2-KLH conjugate plus the immunological adjuvant QS21 in patient with prostate cancer that Induces an antibody response to MUC-2. and induces helper T and/or cytotoxic T cell response against MUC -2.
Time frame: conclusion of study
To determine the safety of immunization with MUC-2-KLH conjugate prepared using an MBS heterobifunctional linker plus QS21.
Time frame: conclusion of study
To determine the effect of MUC-2-KLH dose on the T cell response against MUC-2 and by skin testing.
Time frame: conclusion of study
3 secondary outcomes
To assess post-immunization changes in prostate specific antigen levels and other objective parameters or disease (radionuclide bone scan and/or measurable disease if present).
Time frame: conclusion of study
To monitor changes in serum CASA levels prior to and following treatment.
Time frame: conclusion of study
To monitor sequentially, the peripheral blood for the presence of PSA mRNA in circulating cells using a PCR based assay.
Time frame: conclusion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2012.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Susan Slovin, MD,PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MUC-2-KLH in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center 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 16 inclusion and 8 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: finished, as of the sponsor's last update on 31 Jan 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 determine an optimal dose of the MUC-2-KLH conjugate plus the immunological adjuvant QS21 in patient with prostate cancer that Induces an antibody response to MUC-2. and induces helper T and/or cytotoxic T cell response against MUC -2. (time frame: conclusion of study). The study lists 3 primary outcomes in all. 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 31 Jan 2012.