BreastcancerPhase 1NCT03014076
Immunotherapy Vaccine and Herceptin in Breast Cancer
A Phase 1 study testing GP2 peptide + GM-CSF vaccine plus trastuzumab and Trastuzumab in people with Breastcancer, run by Cancer Insight, LLC.
Trial summary
The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2 peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastcancer
- What is being tested?
- GP2 peptide + GM-CSF vaccine plus trastuzumab and Trastuzumab
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jan 2017
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- HER2/neu+ over-expressing breast cancer (IHC 3+ or FISH ≥2.0)
- Patients who are receiving adjuvant trastuzumab as standard of care treatment
- Completion of breast cancer therapy (i.e., surgery, radiation, and chemotherapy as appropriate per standard of care for patients' specific cancer) to exclude trastuzumab (Patients on oral hormonal therapy as part of their adjuvant breast cancer treatment will be maintained on their regimens.)
- Enrollment must occur so that patients' trastuzumab treatment and vaccine schedule overlap for all 6 vaccinations and so that first vaccination occurs after a standard of care Multiple Gated Acquisition Scan (MUGA)
- ECOG performance status (PS) 0-1
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- Clinically cancer-free (no evidence of disease; excluding +CTC)
- If the patient is of childbearing potential, she must be willing to practice adequate contraception through the study treatment period and for 2 months after completion of the injection sites
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Clinical and/or radiographic evidence of residual or persistent breast cancer
- Receiving immunosuppressive therapy to include methotrexate or steroids (note: the use of prednisone, or equivalent, <2.0mg/day, is allowed)
- Tbili >1.8, creatinin >2, hemoglobin <10, platelets <100,000/mm³, WBC <2,000
- Active pulmonary disease requiring medication to include multiple inhalers
- Patients may not be receiving any other investigational agents (except with permission of the Lead Principal Investigator)
- Pregnant or are nursing
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- History of autoimmune disease (patients with vitiligo not excluded)
- HIV positive
- Previous or concomitant malignancies at other sites, except effectively treated non- melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured
- Other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk
- Uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrollment
- Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study or adequate compliance
About this study
Official title: Phase Ib Trial of Combination Immunotherapy With HER2/Neu Peptide GP2 + GM-CSF Vaccine and Trastuzumab in Breast Cancer Patients
The purpose of this trial is to determine if combination immunotherapy with HER2/neu GP2 peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of the study are the following:
- Assess safety and document local and systemic toxicity to combination immunotherapy with GP2 peptide + GM-CSF vaccine and trastuzumab
- Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab
- Determine maximum tolerated dose and optimal biologic dose for the combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab
- Conditions
- Breastcancer
- Being tested
- GP2 peptide + GM-CSF vaccine plus trastuzumab, Trastuzumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP2 peptide + GM-CSF vaccine plus trastuzumabDrug
HLA-A2+/A3+ subjects are given the GP2 peptide vaccine plus trastuzumab
TrastuzumabDrug
Also called Herceptin
HLA-A2-/A3- patients are followed as controls receiving trastuzumab only.
| Study group | Role | What they receive |
|---|---|---|
| GP2 peptide + GM-CSF + trastuzumab | Experimental | HLA-A2+/A3+ subjects receive GP2 + GM-CSF vaccine and trastzumab Receives: Drug: GP2 peptide + GM-CSF vaccine plus trastuzumab |
| Trastuzumab | Active comparator | HLA-A2-/A3- subjects followed as controls receiving trastuzumab. Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Patients receiving treatment will be followed from baseline to completion of study for adverse events using CTCAE v4.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2017 (estimated)
- Study startJan 2008
- Primary completionJan 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastcancerStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Insight, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, George E. Peoples, Cancer Insight, LLC
- Investigators
- George E Peoples, MD, Principal investigator, Cancer Insight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03014076
- Sponsor's protocol ID
- C.2008.146
- Status last verified
- Jan 2017
- First submitted
- 4 Jan 2017
- Last updated
- 9 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Trial of Combination Immunotherapy With HER2/Neu Peptide GP2 + GM-CSF Vaccine and Trastuzumab in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03014076
- Acronym / sponsor ID
- C.2008.146
- Conditions
- Breastcancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cancer Insight, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 9 Jan 2017 (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 trial is to determine if combination immunotherapy with HER2/neu GP2 peptide + GM-CSF vaccine and trastuzumab is safe and immunologically effective in treatment of patients with HER2/neu over-expressing breast cancer in the adjuvant setting. While not a primary endpoint, time to recurrence is measured for enrolled subjects. The objectives of the study are the following:
- Assess safety and document local and systemic toxicity to combination immunotherapy with GP2 peptide + GM-CSF vaccine and trastuzumab
- Evaluate the in vitro and in vivo immunologic responses to combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab
- Determine maximum tolerated dose and optimal biologic dose for the combination immunotherapy of GP2 peptide + GM-CSF vaccine and trastuzumab
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP2 peptide + GM-CSF + trastuzumab | Experimental | Drug: GP2 peptide + GM-CSF vaccine plus trastuzumabHLA-A2+/A3+ subjects receive GP2 + GM-CSF vaccine and trastzumab |
| Trastuzumab | Active comparator | Drug: TrastuzumabHLA-A2-/A3- subjects followed as controls receiving trastuzumab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years
- HER2/neu+ over-expressing breast cancer (IHC 3+ or FISH ≥2.0)
- Patients who are receiving adjuvant trastuzumab as standard of care treatment
- Completion of breast cancer therapy (i.e., surgery, radiation, and chemotherapy as appropriate per standard of care for patients' specific cancer) to exclude trastuzumab (Patients on oral hormonal therapy as part of their adjuvant breast cancer treatment will be maintained on their regimens.)
- Enrollment must occur so that patients' trastuzumab treatment and vaccine schedule overlap for all 6 vaccinations and so that first vaccination occurs after a standard of care Multiple Gated Acquisition Scan (MUGA)
Key exclusion criteria (12 listed)
- Clinical and/or radiographic evidence of residual or persistent breast cancer
- Receiving immunosuppressive therapy to include methotrexate or steroids (note: the use of prednisone, or equivalent, <2.0mg/day, is allowed)
- Tbili >1.8, creatinin >2, hemoglobin <10, platelets <100,000/mm³, WBC <2,000
- Active pulmonary disease requiring medication to include multiple inhalers
- Patients may not be receiving any other investigational agents (except with permission of the Lead Principal Investigator)
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 |
|---|---|---|
| GP2 peptide + GM-CSF vaccine plus trastuzumabHLA-A2+/A3+ subjects are given the GP2 peptide vaccine plus trastuzumab | Drug | GP2 peptide + GM-CSF + trastuzumab |
| TrastuzumabAlso: HerceptinHLA-A2-/A3- patients are followed as controls receiving trastuzumab only. | Drug | Trastuzumab |
Primary outcome
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 12 months
Patients receiving treatment will be followed from baseline to completion of study for adverse events using CTCAE v4.0
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 9 Jan 2017.
- Individual participant dataSharing planned: No
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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.
George E Peoples, MD principal investigator
Cancer Insight
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GP2 peptide + GM-CSF vaccine plus trastuzumab and Trastuzumab in people with Breastcancer, run by Cancer Insight, LLC.
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 9 inclusion and 12 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 9 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Treatment-Related Adverse Events as Assessed by CTCAE v4.0 (time frame: 12 months). 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 9 Jan 2017.