ProstatePhase 2NCT00579423
Multivalent Conjugate Vaccine Trial for Patients With Biochem. Relapsed Prostate Cancer
A Phase 2 study testing QS21 in people with Prostate and Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This is a pilot trial designed to assess safety and immunogenicity of a multivalent conjugate vaccine for use in patients with biochemically relapsed prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- What is being tested?
- QS21
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2000to Mar 2009
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with prostate cancer that is histologically confirmed.
- Patients must show biochemical progression after primary therapy, including surgery or radiation (with or without neo-adjuvant androgen ablation). This detection of PSA following treatment must occur within two years.
- Patients who have had intermittent hormonal treatment, following primary therapy, who have non-castrate levels of testosterone (>50 ng/ml) are eligible. Hormonal status will be recorded on the basis of serum testosterone levels.
- Karnofsky performance status >60%.
- Patients must have adequate organ function as defined by:
- WBC > or = to 3500/mm3, platelet count > or = to 100,000 mm3.
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- Bilirubin <2.0 mg/100 ml or SGOT <3.0 X's the upper limit of normal.
- Creatinine < or = to 2.0 mg/100 ml or creatinine clearance > or = to 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 with history of melanoma in situ will be permitted since these lesions behave in a manner similar to compound nevi.
- Patients must be at least 18 years of age.
- Patients must sign informed consent.
Who cannot join
- Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
- Radiographic evidence of metastatic disease.
- 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.
- Prior vaccine therapy at outside institution except for phase I monovalent trial performed at MSKCC.
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: A Pilot Multivalent Conjugate Vaccine Trial for Patients With Biochemically Relapsed Prostate Cancer
This is a pilot trial designed to assess safety and immunogenicity of a multivalent conjugate vaccine for use in patients with biochemically relapsed prostate cancer.
Read the detailed description
This is a pilot trial designed to assess safety and immunogenicity of a multivalent conjugate vaccine for use in patients with biochemically relapsed prostate cancer. This trial is based on the results of eight dose-seeking phase I monovalent glycoprotein and carbohydrate conjugate vaccine trials in a patient population with minimal tumor burden despite a rising biomarker, PSA, who have failed primary therapy such as surgery or radiation. We know that a rising PSA is indicative of micrometastatic disease - a state to which the immune system may maximally respond. Based on these trials, we have identified three glycolipid antigens, Globo H, Lewisy and GM2 and three mucin antigens, glycosylated MUC-1, Tn(c), and TF(c) for inclusion into a multivalent trial. As a result of these vaccinations, most patients generated specific high titer IgM and IgG antibodies against the respective antigen-KLH conjugates. Our previous work has shown the monovalent vaccines to be safe with local erythema and edema but minimal systemic toxicities. Our data from approximately 160 men who participated in our earlier monovalent vaccine trials against the aforementioned antigens have shown that a treatment effect in the form of a decline in PSA log slopes compared with pretreatment values could be seen in patients with minimal tumor burden. The multivalent vaccine will consist of the lowest dose of synthetic glycoprotein and carbohydrate antigens shown to elicit high titer IgM and IgG antibodies in patients with biochemically relapsed prostate cancer. A phase III double blind randomized trial with two hundred forty patients is planned based on the safety and immunogenicity data accrued from this pilot trial.
The primary endpoints of this study will be the safety of the vaccine and the humoral response to each of the antigens. The secondary endpoint will be to evaluate post-therapy changes in PSA.
- Being tested
- QS21
- Keywords
- prostate, cancer, vaccine
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QS21Biological
- Treatment schedule and dose: Thirty patients will be treated with specified doses of each carbohydrate or peptide constituent as has been determined. QS21 will be administered at the standard dose of 100 ug.
- Sites: The vaccine conjugate will be administered subcutaneously on a rotating basis to random sites on the upper arms and upper legs.
- Dose modifications: If a patient experiences a Grade III or greater local or Grade II or greater systemic toxicity at any time a decrease by 50% in all components of future vaccinations will be administered for that patient. Any evidence of autoimmunity, however, will result in a cessation of immunization in that patient.
| Study group | Role | What they receive |
|---|---|---|
| vaccine | Experimental | Patients will be treated with specified doses of each carbohydrate or peptide constituent as has been determined. QS21 will be administrated at the standard dose of 100ug. Receives: Biological: QS21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall antitumor assessment performed during weeks 19 and 31. If no progression of disease continue on protocol. After week 31, will be monitored every 3 months with history, physical, performance status and bloodwork. Imaging studies every 6 mo.
Measured: 11/2000-12/2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startNov 2000
- Primary completionMay 2003
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstateStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Capcure
- Investigators
- Susan Slovin, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00579423
- Sponsor's protocol ID
- 00-064
- Status last verified
- Oct 2023
- First submitted
- 20 Dec 2007
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Multivalent Conjugate Vaccine Trial for Patients With Biochemically Relapsed Prostate Cancer
- ClinicalTrials.gov ID
- NCT00579423
- Acronym / sponsor ID
- 00-064
- Keywords
- prostate, cancer, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Capcure
- Study start
- Nov 2000
- Primary completion
- May 2003 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Dec 2007 (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.
This is a pilot trial designed to assess safety and immunogenicity of a multivalent conjugate vaccine for use in patients with biochemically relapsed prostate cancer.
Detailed description
This is a pilot trial designed to assess safety and immunogenicity of a multivalent conjugate vaccine for use in patients with biochemically relapsed prostate cancer. This trial is based on the results of eight dose-seeking phase I monovalent glycoprotein and carbohydrate conjugate vaccine trials in a patient population with minimal tumor burden despite a rising biomarker, PSA, who have failed primary therapy such as surgery or radiation. We know that a rising PSA is indicative of micrometastatic disease - a state to which the immune system may maximally respond. Based on these trials, we have identified three glycolipid antigens, Globo H, Lewisy and GM2 and three mucin antigens, glycosylated MUC-1, Tn(c), and TF(c) for inclusion into a multivalent trial. As a result of these vaccinations, most patients generated specific high titer IgM and IgG antibodies against the respective antigen-KLH conjugates. Our previous work has shown the monovalent vaccines to be safe with local erythema and edema but minimal systemic toxicities. Our data from approximately 160 men who participated in our earlier monovalent vaccine trials against the aforementioned antigens have shown that a treatment effect in the form of a decline in PSA log slopes compared with pretreatment values could be seen in patients with minimal tumor burden. The multivalent vaccine will consist of the lowest dose of synthetic glycoprotein and carbohydrate antigens shown to elicit high titer IgM and IgG antibodies in patients with biochemically relapsed prostate cancer. A phase III double blind randomized trial with two hundred forty patients is planned based on the safety and immunogenicity data accrued from this pilot trial.
The primary endpoints of this study will be the safety of the vaccine and the humoral response to each of the antigens. The secondary endpoint will be to evaluate post-therapy changes in PSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccine | Experimental | Biological: QS21Patients will be treated with specified doses of each carbohydrate or peptide constituent as has been determined. QS21 will be administrated at the standard dose of 100ug. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with prostate cancer that is histologically confirmed.
- Patients must show biochemical progression after primary therapy, including surgery or radiation (with or without neo-adjuvant androgen ablation). This detection of PSA following treatment must occur within two years.
- Patients who have had intermittent hormonal treatment, following primary therapy, who have non-castrate levels of testosterone (>50 ng/ml) are eligible. Hormonal status will be recorded on the basis of serum testosterone levels.
- Karnofsky performance status >60%.
- Patients must have adequate organ function as defined by:
Key exclusion criteria (8 listed)
- Clinically significant cardiac disease (New York Heart Association Class III/IV), or severe debilitating pulmonary disease.
- Radiographic evidence of metastatic disease.
- 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 |
|---|---|---|
| QS21* Treatment schedule and dose: Thirty patients will be treated with specified doses of each carbohydrate or peptide constituent as has been determined. QS21 will be administered at the standard dose of 100 ug. * Sites: The vaccine conjugate will be administered subcutaneously on a rotating basis to random sites on the upper arms and upper legs. * Dose modifications: If a patient experiences a Grade III or greater local or Grade II or greater systemic toxicity at any time a decrease by 50% in all components of future vaccinations will be administered for that patient. Any evidence of autoimmunity, however, will result in a cessation of immunization in that patient. | Biological | vaccine |
Primary outcome
Overall antitumor assessment performed during weeks 19 and 31. If no progression of disease continue on protocol. After week 31, will be monitored every 3 months with history, physical, performance status and bloodwork. Imaging studies every 6 mo.
Time frame: 11/2000-12/2008
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 5 Oct 2023.
- 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 2 study testing QS21 in people with Prostate and 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 12 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 5 Oct 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Overall antitumor assessment performed during weeks 19 and 31. If no progression of disease continue on protocol. After week 31, will be monitored every 3 months with history, physical, performance status and bloodwork. Imaging studies every 6 mo. (time frame: 11/2000-12/2008). 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 5 Oct 2023.