Breast CancerPhase 1J65NCT02019524
Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
A Phase 1 study testing E39 peptide vaccine, E39 vaccine then J65 vaccine and J65 vaccine then E39 vaccine in people with Breast Cancer and Ovarian Cancer, run by COL George Peoples, MD, FACS at 1 site in United States.
Trial summary
This is a single-center, randomized, single-blinded, three-arm phase Ib study of the folate binding protein vaccines E39 and J65. The study target population are patients with breast or ovarian cancer diagnosis who have been treated and are without evidence of disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Ovarian Cancer
- What is being tested?
- E39 peptide vaccine, E39 vaccine then J65 vaccine and J65 vaccine then E39 vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2013to 6 Dec 2016
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have breast or ovarian cancer
- Patients must have completed primary breast or ovarian cancer therapy (i.e., surgery, chemotherapy, immunotherapy and/or radiation therapy as appropriate per standard of care for patient's specific cancer)
- Patients must be without evidence of residual disease as assessed by their treatment team
- Patients must be either post-menopausal or surgically post-menopausal
- Patients must be HLA-A2 positive
- Patients must have a good performance status (ECOG<2)
Who cannot join
- HLA-A2 negative patients
- Currently receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
- In poor health (Karnofsky <60%, ECOG >2)
- Total bilirubin >1.5, creatinine >2, hemoglobin <10, platelets <50,000, WBC <2,000
- Active pulmonary disease requiring medication to include multiple inhalers
- Of child-bearing age with intact reproductive organs
- Involved in other experimental protocols (except with permission of the other study PI)
- History of autoimmune disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase Ib Trial of Two Folate Binding Protein (FBP) Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
This is a single-center, randomized, single-blinded, three-arm phase Ib study of the folate binding protein vaccines E39 and J65. The study target population are patients with breast or ovarian cancer diagnosis who have been treated and are without evidence of disease. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA typed. E39 and J65 are cytotoxic T-lymphocyte-eliciting peptide vaccines that are restricted to HLA-A2+ patients (approximately 50% of the U.S. population).
Read the detailed description
The study is a prospective, randomized, non-blinded, single-center Phase Ib trial. Patients will be identified that have a diagnosis of breast or ovarian cancer, have completed their standard courses of therapy and are disease-free. They will be properly screened, counseled and consented prior to enrollment. Once enrolled, each patient's blood will be tested for HLA-A2 status (approximately 50% will be HLA-A2+). Additionally, their tumors will be tested for FBP-expression and this information will be tracked for purposes of correlative science.
Patients who are HLA-A2+ will be stratified based on cancer diagnosis (breast versus ovarian), then randomized by computer tables to one of three arms for the PVS. Each arm will receive 6 monthly injections of peptide + GM-CSF. Arm A will receive six inoculations with E39 peptide; arm B will receive three inoculations with E39 followed by three with J65; and arm C will receive three inoculations with J65, followed by three of E39. Since J65 has not been previously used in humans, a two week waiting period will be instituted between the first and second patients enrolled in either Arm B or C. Immunologic data will be assessed at 1 month and 6 months (±2 wks) after the PVS, specifically ex vivo immunologic recognition of E39 and J65 will be assessed by clonal expansion using a dextramer assay and the in vivo response will be assessed by Delayed Type Hypersensitivity (DTH). Immunologic recognition of E39 will be the primary endpoint, with recognition of J65 serving as an additional data point. The 6 month post-PVS immunologic data will then be used to assess each patient for significant residual immunity (SRI), defined as ≥2-fold increase in E39-specific CD8+ T-cells from the pre-vaccination level. Patients will then be sorted into two groups: those with SRI and those without. Patients within each group will then be randomized to receive one booster of either J65 or E39. Each patient will return to clinic within 1-2 weeks of their 6mo post-PVS visit to receive their single booster inoculation. This second randomization will result in four groups: 1) patients with SRI receiving E39; 2) patients with SRI receiving J65; 3) patients without SRI receiving E39; 4) patients without SRI receiving J65. Immunologic data will then again be gathered at 1 month (±2 wks) and 6 months (±2 wks) post-booster. This final immunologic data will be analyzed for differences between the four groups. Additionally, toxicity data will be gathered.
Patients will be monitored closely for one hour after each inoculation with questioning, serial exams, and vital signs every 15 minutes. Patients will then be asked to return to the vaccine clinic 48-72 hours after each inoculation for questioning regarding any local or systemic toxicity and to examine and measure the local reaction at the vaccination sites. The graded toxicity scale (NCI Common Terminology Criteria for Adverse Events, v4.03) will be utilized to assess local and systemic toxicity. GM-CSF dose reduction may be required if >10cm of erythema and induration is seen at the injection site after any given inoculation.
- Conditions
- Breast Cancer, Ovarian Cancer
- Being tested
- E39 peptide vaccine, E39 vaccine then J65 vaccine, J65 vaccine then E39 vaccine
- Keywords
- Stage I breast cancer, Stage II breast cancer, Stage IIIA, IIIB, and IIIC breast cancer, Male breast cancer, Ovarian cancer
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E39 peptide vaccineBiological
Also called E39 peptide (EIWTHSYKV, Folate Binding Protein, 191-199), GM-CSF (Sargramostim)
500mcg of lyophilized E39 peptide is suspended in bacteriostatic saline for injection and then frozen. At the time of vaccine administration, one vial of frozen suspended peptide is thawed and mixed with 250mcg GM-CSF in the syringe. This constitutes the E39 peptide vaccine. For patients randomized to the E39 vaccine arm, the primary vaccine series (PVS) consists of E39 vaccine administered intradermally every three to four weeks for six total vaccinations. After completion of the PVS, patients are assessed for significant residual immunity (SRI). Patients with SRI will be randomized to receive one inoculation of either the E39 vaccine or the J65 vaccine. Patients without SRI will be randomized to receive one inoculation of either the E39 vaccine or the J65 vaccine.
E39 vaccine then J65 vaccineBiological
Also called J65 peptide (EIWTFSTKV, Folate Binding Protein), GM-CSF (Sargramostim), E39 peptide (EIWTHSYKV, Folate Binding Protein, 191-199)
The E39 vaccine is prepared as noted above. For the J65 vaccine, 500mcg J65 peptide is suspended in bacteriostatic saline for injection and then frozen. At the time of vaccine administration, one vial of frozen suspended E39 peptide is thawed and mixed with 250mcg GM-CSF in the syringe. This constitutes the J65 vaccine. For patients randomized to this arm, the primary vaccine series (PVS) consists of the E39 vaccine administered intradermally every 3-4 weeks for 3 total vaccinations. Patients are then administered the J65 vaccine every 3-4 weeks for a total of 3 vaccinations. After completion of the PVS, patients are assessed for significant residual immunity (SRI). Patients with SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine. Patients without SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine.
J65 vaccine then E39 vaccineBiological
Also called J65 peptide (EIWTFSTKV, Folate Binding Protein), GM-CSF (Sargramostim), E39 peptide (EIWTHSYKV, Folate Binding Protein, 191-199)
The E39 and J65 vaccines are prepared as noted above. For patients randomized to this arm, the primary vaccine series (PVS) consists of the J65 vaccine administered intradermally every 3-4 weeks for 3 total vaccinations. Patients are then administered the E39 vaccine every 3-4 weeks for a total of 3 vaccinations. After completion of the PVS, patients are assessed for significant residual immunity (SRI). Patients with SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine. Patients without SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine.
| Study group | Role | What they receive |
|---|---|---|
| E39 peptide vaccine | Experimental | Patients receive 6 monthly injections of E39 peptide + GM-CSF. Immunologic data is assessed at 1 month and 6 months (+/- 2 weeks) after the primary vaccine series (PVS), specifically ex vivo immunologic recognition of E39 and J65 is assessed by clonal expansion using a dextramer assay and the in vivo response is assessed by delayed type hypersensitivity. The 6-month post-PVS immunologic data is then used to assess each patient for significant residual immunity. Patients are then sorted into two groups: those with SRI and those without. Patients within each group will be randomized to receive 1 booster inoculation of the J65 vaccine or the E39 vaccine. Patients return to the clinic within 1-2 weeks of their 6-month post-PVS visit to receive their booster inoculation. Receives: Biological: E39 peptide vaccine |
| E39 vaccine then J65 vaccine | Experimental | Patients receive 3 inoculations with the E39 vaccine followed by 3 inoculations with the J65 vaccine. Immunologic data is assessed at 1 month and 6 months (+/- 2 weeks) after the primary vaccine series (PVS), specifically ex vivo immunologic recognition of E39 and J65 is assessed by clonal expansion using a dextramer assay and the in vivo response is assessed by delayed type hypersensitivity. The 6-month post-PVS immunologic data is then used to assess each patient for significant residual immunity. Patients are then sorted into two groups: those with SRI and those without. Patients within each group will be randomized to receive 1 booster inoculation of the J65 vaccine or the E39 vaccine. Patients return to the clinic within 1-2 weeks of their 6-month post-PVS visit to receive their booster inoculation. Receives: Biological: E39 vaccine then J65 vaccine |
| J65 vaccine then E39 vaccine | Experimental | Patients receive 3 inoculations with the J65 vaccine followed by 3 inoculations with the E39 vaccine. Immunologic data is assessed at 1 month and 6 months (+/- 2 weeks) after the primary vaccine series (PVS), specifically ex vivo immunologic recognition of E39 and J65 is assessed by clonal expansion using a dextramer assay and the in vivo response is assessed by delayed type hypersensitivity. The 6-month post-PVS immunologic data is then used to assess each patient for significant residual immunity. Patients are then sorted into two groups: those with SRI and those without. Patients within each group will be randomized to receive 1 booster inoculation of the J65 vaccine or the E39 vaccine. Patients return to the clinic within 1-2 weeks of their 6-month post-PVS visit to receive their booster inoculation. Receives: Biological: J65 vaccine then E39 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary vaccination strategy
Determine which of the following primary vaccination strategy maximizes long-term specific immunity defined as E39-specific cytotoxic T lymphocytes (CTLs) six months following completion of the primary vaccination series.
Measured: Six months after completion of primary vaccination series (month 12 of trial)
Secondary outcomes (3)
Short-term immunity
To determine the most effective vaccination strategy to maximize short-term immunity defined as E39-specific CTLs one month following completion of the primary vaccination series.
Measured: One month after completion of primary vaccination series (month 7 of trial)
Optimal booster inoculation strategy
To determine the most effective booster inoculations (i.e., E39 or J65 peptides) to maximize long-lasting immunity defined as E39-specific cytotoxic T lymphocytes six months following administration of the booster inoculations.
Measured: Twelve months after completion of primary vaccination series (month 18 of trial)
Delayed Type Hypersensitivity evaluation
Mean change in size of Delayed Type Hypersensitivity (DTH) reactions from baseline to 12 months post-completion of the primary vaccination series. Measurements of DTH reactions will be taken at baseline, then at month 7, 12, 17 and 18.
Measured: Baseline to six months after completion of primary vaccination series (month 18 of trial)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study start30 Sep 2013
- Primary completion6 Dec 2016
- Study completion6 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- COL George Peoples, MD, FACS
- Sponsor type
- US federal agency
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor-investigator, COL George Peoples, MD, FACS, San Antonio Military Medical Center
- Investigators
- Elizabeth Mittendorf, MD, Principal investigator, Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019524
- Sponsor's protocol ID
- 2013-0139
- Acronym
- J65
- Status last verified
- Mar 2020
- First submitted
- 25 Nov 2013
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vreeland TJ, Litton JK, Qiao N, Philips AV, Alatrash G, Hale DF, Jackson DO, Peace KM, Greene JM, Berry JS, Clifton GT, Peoples GE, Mittendorf EA. Phase Ib trial of folate binding protein (FBP)-derived peptide vaccines, E39 and an attenuated version, E39': An analysis of safety and immune response. Clin Immunol. 2018 Jul;192:6-13. doi: 10.1016/j.clim.2018.03.010. Epub 2018 Mar 21.
PubMed 29574039
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Trial of Two Folate Binding Protein (FBP) Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
- ClinicalTrials.gov ID
- NCT02019524
- Acronym / sponsor ID
- J65 / 2013-0139
- Conditions
- Breast Cancer, Ovarian Cancer
- Keywords
- Stage I breast cancer, Stage II breast cancer, Stage IIIA, IIIB, and IIIC breast cancer, Male breast cancer, Ovarian cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- COL George Peoples, MD, FACSUS federal agency
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 30 Sep 2013
- Primary completion
- 6 Dec 2016 (actual)
- Study completion
- 6 Dec 2016 (actual)
- First posted
- 24 Dec 2013 (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 single-center, randomized, single-blinded, three-arm phase Ib study of the folate binding protein vaccines E39 and J65. The study target population are patients with breast or ovarian cancer diagnosis who have been treated and are without evidence of disease. Disease-free subjects after standard of care multi-modality therapy will be screened and HLA typed. E39 and J65 are cytotoxic T-lymphocyte-eliciting peptide vaccines that are restricted to HLA-A2+ patients (approximately 50% of the U.S. population).
Detailed description
The study is a prospective, randomized, non-blinded, single-center Phase Ib trial. Patients will be identified that have a diagnosis of breast or ovarian cancer, have completed their standard courses of therapy and are disease-free. They will be properly screened, counseled and consented prior to enrollment. Once enrolled, each patient's blood will be tested for HLA-A2 status (approximately 50% will be HLA-A2+). Additionally, their tumors will be tested for FBP-expression and this information will be tracked for purposes of correlative science.
Patients who are HLA-A2+ will be stratified based on cancer diagnosis (breast versus ovarian), then randomized by computer tables to one of three arms for the PVS. Each arm will receive 6 monthly injections of peptide + GM-CSF. Arm A will receive six inoculations with E39 peptide; arm B will receive three inoculations with E39 followed by three with J65; and arm C will receive three inoculations with J65, followed by three of E39. Since J65 has not been previously used in humans, a two week waiting period will be instituted between the first and second patients enrolled in either Arm B or C. Immunologic data will be assessed at 1 month and 6 months (±2 wks) after the PVS, specifically ex vivo immunologic recognition of E39 and J65 will be assessed by clonal expansion using a dextramer assay and the in vivo response will be assessed by Delayed Type Hypersensitivity (DTH). Immunologic recognition of E39 will be the primary endpoint, with recognition of J65 serving as an additional data point. The 6 month post-PVS immunologic data will then be used to assess each patient for significant residual immunity (SRI), defined as ≥2-fold increase in E39-specific CD8+ T-cells from the pre-vaccination level. Patients will then be sorted into two groups: those with SRI and those without. Patients within each group will then be randomized to receive one booster of either J65 or E39. Each patient will return to clinic within 1-2 weeks of their 6mo post-PVS visit to receive their single booster inoculation. This second randomization will result in four groups: 1) patients with SRI receiving E39; 2) patients with SRI receiving J65; 3) patients without SRI receiving E39; 4) patients without SRI receiving J65. Immunologic data will then again be gathered at 1 month (±2 wks) and 6 months (±2 wks) post-booster. This final immunologic data will be analyzed for differences between the four groups. Additionally, toxicity data will be gathered.
Patients will be monitored closely for one hour after each inoculation with questioning, serial exams, and vital signs every 15 minutes. Patients will then be asked to return to the vaccine clinic 48-72 hours after each inoculation for questioning regarding any local or systemic toxicity and to examine and measure the local reaction at the vaccination sites. The graded toxicity scale (NCI Common Terminology Criteria for Adverse Events, v4.03) will be utilized to assess local and systemic toxicity. GM-CSF dose reduction may be required if >10cm of erythema and induration is seen at the injection site after any given inoculation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| E39 peptide vaccine | Experimental | Biological: E39 peptide vaccinePatients receive 6 monthly injections of E39 peptide + GM-CSF. Immunologic data is assessed at 1 month and 6 months (+/- 2 weeks) after the primary vaccine series (PVS), specifically ex vivo immunologic recognition of E39 and J65 is assessed by clonal expansion using a dextramer assay and the in vivo response is assessed by delayed type hypersensitivity. The 6-month post-PVS immunologic data is then used to assess each patient for significant residual immunity. Patients are then sorted into two groups: those with SRI and those without. Patients within each group will be randomized to receive 1 booster inoculation of the J65 vaccine or the E39 vaccine. Patients return to the clinic within 1-2 weeks of their 6-month post-PVS visit to receive their booster inoculation. |
| E39 vaccine then J65 vaccine | Experimental | Biological: E39 vaccine then J65 vaccinePatients receive 3 inoculations with the E39 vaccine followed by 3 inoculations with the J65 vaccine. Immunologic data is assessed at 1 month and 6 months (+/- 2 weeks) after the primary vaccine series (PVS), specifically ex vivo immunologic recognition of E39 and J65 is assessed by clonal expansion using a dextramer assay and the in vivo response is assessed by delayed type hypersensitivity. The 6-month post-PVS immunologic data is then used to assess each patient for significant residual immunity. Patients are then sorted into two groups: those with SRI and those without. Patients within each group will be randomized to receive 1 booster inoculation of the J65 vaccine or the E39 vaccine. Patients return to the clinic within 1-2 weeks of their 6-month post-PVS visit to receive their booster inoculation. |
| J65 vaccine then E39 vaccine | Experimental | Biological: J65 vaccine then E39 vaccinePatients receive 3 inoculations with the J65 vaccine followed by 3 inoculations with the E39 vaccine. Immunologic data is assessed at 1 month and 6 months (+/- 2 weeks) after the primary vaccine series (PVS), specifically ex vivo immunologic recognition of E39 and J65 is assessed by clonal expansion using a dextramer assay and the in vivo response is assessed by delayed type hypersensitivity. The 6-month post-PVS immunologic data is then used to assess each patient for significant residual immunity. Patients are then sorted into two groups: those with SRI and those without. Patients within each group will be randomized to receive 1 booster inoculation of the J65 vaccine or the E39 vaccine. Patients return to the clinic within 1-2 weeks of their 6-month post-PVS visit to receive their booster inoculation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must have breast or ovarian cancer
- Patients must have completed primary breast or ovarian cancer therapy (i.e., surgery, chemotherapy, immunotherapy and/or radiation therapy as appropriate per standard of care for patient's specific cancer)
- Patients must be without evidence of residual disease as assessed by their treatment team
- Patients must be either post-menopausal or surgically post-menopausal
- Patients must be HLA-A2 positive
Key exclusion criteria (8 listed)
- HLA-A2 negative patients
- Currently receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
- In poor health (Karnofsky <60%, ECOG >2)
- Total bilirubin >1.5, creatinine >2, hemoglobin <10, platelets <50,000, WBC <2,000
- Active pulmonary disease requiring medication to include multiple inhalers
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 |
|---|---|---|
| E39 peptide vaccineAlso: E39 peptide (EIWTHSYKV, Folate Binding Protein, 191-199), GM-CSF (Sargramostim)500mcg of lyophilized E39 peptide is suspended in bacteriostatic saline for injection and then frozen. At the time of vaccine administration, one vial of frozen suspended peptide is thawed and mixed with 250mcg GM-CSF in the syringe. This constitutes the E39 peptide vaccine. For patients randomized to the E39 vaccine arm, the primary vaccine series (PVS) consists of E39 vaccine administered intradermally every three to four weeks for six total vaccinations. After completion of the PVS, patients are assessed for significant residual immunity (SRI). Patients with SRI will be randomized to receive one inoculation of either the E39 vaccine or the J65 vaccine. Patients without SRI will be randomized to receive one inoculation of either the E39 vaccine or the J65 vaccine. | Biological | E39 peptide vaccine |
| E39 vaccine then J65 vaccineAlso: J65 peptide (EIWTFSTKV, Folate Binding Protein), GM-CSF (Sargramostim), E39 peptide (EIWTHSYKV, Folate Binding Protein, 191-199)The E39 vaccine is prepared as noted above. For the J65 vaccine, 500mcg J65 peptide is suspended in bacteriostatic saline for injection and then frozen. At the time of vaccine administration, one vial of frozen suspended E39 peptide is thawed and mixed with 250mcg GM-CSF in the syringe. This constitutes the J65 vaccine. For patients randomized to this arm, the primary vaccine series (PVS) consists of the E39 vaccine administered intradermally every 3-4 weeks for 3 total vaccinations. Patients are then administered the J65 vaccine every 3-4 weeks for a total of 3 vaccinations. After completion of the PVS, patients are assessed for significant residual immunity (SRI). Patients with SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine. Patients without SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine. | Biological | E39 vaccine then J65 vaccine |
| J65 vaccine then E39 vaccineAlso: J65 peptide (EIWTFSTKV, Folate Binding Protein), GM-CSF (Sargramostim), E39 peptide (EIWTHSYKV, Folate Binding Protein, 191-199)The E39 and J65 vaccines are prepared as noted above. For patients randomized to this arm, the primary vaccine series (PVS) consists of the J65 vaccine administered intradermally every 3-4 weeks for 3 total vaccinations. Patients are then administered the E39 vaccine every 3-4 weeks for a total of 3 vaccinations. After completion of the PVS, patients are assessed for significant residual immunity (SRI). Patients with SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine. Patients without SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine. | Biological | J65 vaccine then E39 vaccine |
Primary outcome
Primary vaccination strategy
Time frame: Six months after completion of primary vaccination series (month 12 of trial)
Determine which of the following primary vaccination strategy maximizes long-term specific immunity defined as E39-specific cytotoxic T lymphocytes (CTLs) six months following completion of the primary vaccination series.
3 secondary outcomes
Short-term immunity
Time frame: One month after completion of primary vaccination series (month 7 of trial)
Optimal booster inoculation strategy
Time frame: Twelve months after completion of primary vaccination series (month 18 of trial)
Delayed Type Hypersensitivity evaluation
Time frame: Baseline to six months after completion of primary vaccination series (month 18 of trial)
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 18 Mar 2020.
- Derived from this study: PubMed 29574039Vreeland TJ, Litton JK, Qiao N, Philips AV, Alatrash G, Hale DF, Jackson DO, Peace KM, Greene JM, Berry JS, Clifton GT, Peoples GE, Mittendorf EA. Phase Ib trial of folate binding protein (FBP)-derived peptide vaccines, E39 and an attenuated version, E39': An analysis of safety and immune response. Clin Immunol. 2018 Jul;192:6-13. doi: 10.1016/j.clim.2018.03.010. Epub 2018 Mar 21.
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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.
Elizabeth Mittendorf, MD principal investigator
Department of Breast Surgical Oncology, The University of Texas MD Anderson 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 E39 peptide vaccine, E39 vaccine then J65 vaccine and J65 vaccine then E39 vaccine in people with Breast Cancer and Ovarian Cancer, run by COL George Peoples, MD, FACS 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 6 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 18 Mar 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.
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?
Primary vaccination strategy (time frame: Six months after completion of primary vaccination series (month 12 of trial)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02019524, which also lists 1 linked publication.
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 Mar 2020.