Breast CancerNCT00470574
Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer
A study testing QS21, sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine and immunoenzyme technique in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- QS21, sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine and immunoenzyme technique
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2007to 24 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed stage IV breast cancer meeting 1 of the following criteria:
- No evidence of disease
- Stable disease on hormonal therapy
- Stable disease must be present for ≥ 2 months and include < 30% decrease or < 20% increase in the sum of the longest diameter of target lesion
- No new target lesions or unequivocal progression of non-target lesions
- Elevation in the CA 153 (BR2729) or CEA values allowed
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female or male
- Menopausal status not specified
- Karnofsky performance status 80-100%
- Lymphocyte count ≥ 500/mm³
- WBC ≥ 3,000/mm³
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 1.5 times ULN
- Alkaline phosphatase ≤ 1.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergy to seafood
- No NYHA class III-IV cardiac disease
- No other active cancers except basal cell or squamous cell carcinoma of the skin
- No active infection requiring antibiotic treatment
- No known history of immunodeficiency or autoimmune disease
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- At least 4 weeks since prior radiotherapy
- At least 4 weeks since prior surgery
- At least 6 weeks since prior immunotherapy
- No prior sialyl Lewisª antigen
- No concurrent immunosuppressive medications (i.e., corticosteroids)
- Concurrent hormonal therapy allowed
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: Pilot Study of Immunization of High Risk Breast Cancer Patients With a Sialyl Lewisª -Keyhole Limpet Hemocyanin Conjugate Plus the Immunological Adjuvant QS-21
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy together with QS21 works in treating patients with metastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the safety of sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine and QS21 immunoadjuvant in patients with metastatic breast cancer.
- Determine the IgG and IgM antibody response to this regimen in these patients.
- Determine the proportion of breast cancer cells expressing this antigen in these patients.
Secondary
- Monitor the presence of circulating tumor cells prior to, during, and after this regimen in these patients.
OUTLINE: Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.
Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.
After completion of study treatment, patients are followed every 3 months.
- Conditions
- Breast Cancer
- Being tested
- QS21, sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine, immunoenzyme technique, immunologic technique, laboratory biomarker analysis
- Keywords
- recurrent breast cancer, stage IV breast cancer, male breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QS21Biological
sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccineBiological
immunoenzyme techniqueOther
immunologic techniqueOther
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Therapy and QS21 | Experimental | Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.
Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.
After completion of study treatment, patients are followed every 3 months Receives: Biological: QS21; Biological: sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine; Other: immunoenzyme technique; Other: immunologic technique; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: 2 years
Immune Response
Measured: 2 years
Secondary outcomes (1)
Presence of Circulating Tumor Cells
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2007 (estimated)
- Study start20 Mar 2007
- Primary completion24 Jan 2020
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Teresa Ann Gilewski, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00470574
- Sponsor's protocol ID
- 06-156
- Other IDs
- P30CA008748, MSKCC-06156
- Status last verified
- Nov 2020
- First submitted
- 3 May 2007
- Last updated
- 18 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Immunization of High Risk Breast Cancer Patients With a Sialyl Lewisª -Keyhole Limpet Hemocyanin Conjugate Plus the Immunological Adjuvant QS-21
- ClinicalTrials.gov ID
- NCT00470574
- Acronym / sponsor ID
- 06-156
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IV breast cancer, male breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Mar 2007 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 7 May 2007 (estimated)
- Results
- Posted 16 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy together with QS21 works in treating patients with metastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the safety of sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine and QS21 immunoadjuvant in patients with metastatic breast cancer.
- Determine the IgG and IgM antibody response to this regimen in these patients.
- Determine the proportion of breast cancer cells expressing this antigen in these patients.
Secondary
- Monitor the presence of circulating tumor cells prior to, during, and after this regimen in these patients.
OUTLINE: Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease.
Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays.
After completion of study treatment, patients are followed every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine Therapy and QS21 | Experimental | Biological: QS21, Biological: sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine, Other: immunoenzyme technique, Other: immunologic technique, Other: laboratory biomarker analysisPatients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease. Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays. After completion of study treatment, patients are followed every 3 months |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 | Biological | Vaccine Therapy and QS21 |
| sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine | Biological | Vaccine Therapy and QS21 |
| immunoenzyme technique | Other | Vaccine Therapy and QS21 |
| immunologic technique | Other | Vaccine Therapy and QS21 |
| laboratory biomarker analysis | Other | Vaccine Therapy and QS21 |
Primary outcome
Safety
Time frame: 2 years
Immune Response
Time frame: 2 years
1 secondary outcome
Presence of Circulating Tumor Cells
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Teresa Ann Gilewski, MD 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 study testing QS21, sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine and immunoenzyme technique in people with Breast 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?
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 18 Nov 2020. 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?
Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety (time frame: 2 years). The study lists 2 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 18 Nov 2020.