Breast CancerPhase 2NCT00784524
Phase II Study of Allo LMI Vaccine With IL-2 for Stable Metastatic Breast Ca
A Phase 2 study testing allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving vaccine therapy together with aldesleukin may be a more effective treatment for metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jul 2014
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IV, metastatic breast cancer, confirmed by histology or cytology.
- Disease must be refractory to hormone therapy for tumors that estrogen and/or progesterone receptor positive
- Disease must be refractory to trastuzumab for tumors that are HER2 positive
- Disease must be responsive to chemotherapy such that regression or at least stabilization occurs
- Stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease
- Measurement of regressed or stable disease must be confirmed by repeat evaluation no less than 4 weeks after the initial determination.
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- Prior systemic chemotherapy, immunotherapy, biological therapy, or investigational drug therapy is allowed if at least 4 weeks since last treatment.
- Patient must recover from the acute toxic effects of the treatment prior to study enrollment.
- There is no limit as to the number of previous chemotherapy regimens received.
- Disease status may be measurable or non-measurable
- Karnofsky performance status >70%
- Women, age 18 years or older
- Adequate organ function within 14 days of study registration including the following:
- Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 10^9/L, platelets ≥75 x 10^9/L, and hemoglobin ≥ 8.0 g/dL
- Hepatic: bilirubin ≤ 3 times the upper limit of normal (× ULN) for patients without tumor involvement of the liver and ≤ 5 X ULN for patients with tumor involvement of the liver; aspartate transaminase (AST) ≤ 2.5 × ULN for patients without tumor involvement of the liver and ≤ 5 X ULN for patients with tumor involvement of the liver
- Renal: creatinine ≤ 2.0 mg/dL
- Must share at least one class I HLA allele with the HLA-type SKBR3 cell (class I alleles A2, A3, B14, B40, C3, C8)
- Meets eligibility criteria for and agrees to enroll in "MT1999-06: Vaccination with Tetanus Toxoid and Keyhole Limpet Hemocyanin (KLH) to Assess Antigen-Specific Immune Responses" (IRB # 9904M01581, CPRC #2002LS032). Patients who have had tetanus toxoid within the last 7 years will not receive the tetanus vaccine component. For patients who do not know the year of their last tetanus vaccine, tetanus toxoid will be given per protocol. Subjects allergic to seafood will not be co-enrolled into MT1996-06.
- Women of childbearing potential and their partners are required to use an effective method of contraception (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 3 months after the last dose of study drug.
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Who cannot join
- History of untreated or active brain metastases or positive brain scan at enrollment. Patients with previously treated brain metastases are eligible if stable by CT or MRI for at least 3 months.
- Concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
- Active infection
- Solid organ transplantation or autoimmune diseases requiring systemic immunosuppressive therapy; however, topical or inhalational steroids are allowed.
- Symptomatic pulmonary disease (symptoms of dyspnea or rales, wheezes or rhonchi on physical exam) will require pulmonary function testing (PFTs). Those with FEV1 <50% of predicted or corrected DLCO <50% are not eligible.
- Patients with cardiac disease such as recent myocardial infarction (< 3 months prior), unstable angina, or heart failure requiring medical intervention will undergo cardiac evaluation. Cardiac testing may include ECG, MUGA or echocardiogram, and/or thallium stress test as indicated to evaluate cardiac risks. Those patients with exercise-induced ischemia or an ejection fraction by MUGA or echocardiogram < 40% are not eligible.
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- Hypersensitivity to any component of the vaccine, including Thimerosal, a mercury derivative, is a contraindication (taken from tetanus toxoid package insert).
- The occurrence of any type of neurologic symptoms to tetanus vaccine in the past is a contraindication to further use (taken from tetanus toxoid package insert).
- Pregnant (positive pregnancy test) or lactating women. Use of LMI vaccine during pregnancy is not approved for use by the FDA during pregnancy. IL-2 is pregnancy category C - risk in pregnancy cannot be ruled out.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: A Phase II Study of Allogeneic Large Multivalent Immunogen (LMI) Vaccine and IL-2 for the Treatment of Stable Metastatic Breast Cancer
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving vaccine therapy together with aldesleukin may be a more effective treatment for metastatic breast cancer.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with aldesleukin works in treating women with metastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the efficacy of allogeneic large multivalent immunogen (LMI) vaccine and aldesleukin, as defined by clinical benefit rate (percentage of patients demonstrating a complete response, partial response, or disease stabilization as assessed by RECIST criteria), in women with stable metastatic breast cancer.
Secondary
- To measure the immune response in patients treated with this regimen.
- To determine the progression-free survival of patients treated with this regimen.
- To determine the 1- and 2-year overall survival rates in patients treated with this regimen.
- To determine the safety profile and toxicity of this regimen in these patients.
OUTLINE: Patients receive allogeneic large multivalent immunogen (LMI) vaccine intradermally on day 1 and aldesleukin subcutaneously on days 7 and 8. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 courses of vaccine therapy resume the chemotherapy regimen for which prior disease stabilization was achieved. Beginning 2-4 days after completion of chemotherapy, patients receive one dose of LMI vaccine followed by aldesleukin on days 7 and 8. Patients achieving at least stable disease continue to receive LMI vaccine and aldesleukin as above. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Peripheral blood mononuclear cell samples are collected periodically for research studies. Samples are analyzed to assess the frequency of leukocyte subsets (including B cells, T cells, NK cells, and monocytes) via flow cytometry; frequency of T-regs (T cells that express CD4, CD25, and FoxP3); and responses to keyhole limpet hemocyanin and tetanus toxoid via ELISA assay. Other immunological studies are also performed.
After completion of study therapy, patients are followed every 3 months.
- Conditions
- Breast Cancer
- Being tested
- allogeneic large multivalent immunogen breast cancer vaccine, aldesleukin
- Keywords
- stage IV breast cancer, recurrent breast cancer, metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic large multivalent immunogen breast cancer vaccineBiological
Also called LMI
Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.
aldesleukinBiological
Also called Interleukin-2, IL-2, Proleukin
Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection.
| Study group | Role | What they receive |
|---|---|---|
| LMI Vaccination + IL-2 | Experimental | Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin. Receives: Biological: allogeneic large multivalent immunogen breast cancer vaccine; Biological: aldesleukin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Response
Percentage of patients achieving complete response, partial response, or disease stabilization as assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) criteria for measurable target lesions and non-measurable non-target lesions assessed by CT, PET-CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions or persistence of one or more non-target lesions; Disease Stabilization (SD), Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease; Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Measured: Up to 2 years
Secondary outcomes (4)
Immune Response
Immune responses will be assessed by DTH responses to LMI, IFN-gamma production by CD8+ T cells using the ELISPOT assay, and CD8+ T cell binding to HLA-A2 multimers complexed with breast cancer-derived peptides (multimer analysis).
Measured: 48 hours
Progression-free Survival
Progression free survival will be measured in months from time of response to time of disease progression as defined by RECIST (appendix II), "at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s)."
Measured: Up to 1 year
Overall Survival
Number of participants alive at one year
Measured: 1 Year
Overall Survival
Number of participants alive at 2 years
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 posted4 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Slow accrual
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 Masonic Cancer Center, University of MinnesotaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Yee, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784524
- Sponsor's protocol ID
- 2007LS094
- Other IDs
- 0802M25946
- Status last verified
- May 2019
- First submitted
- 1 Nov 2008
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Allogeneic Large Multivalent Immunogen (LMI) Vaccine and IL-2 for the Treatment of Stable Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00784524
- Acronym / sponsor ID
- 2007LS094
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer, metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Nov 2008 (estimated)
- Results
- Posted 6 Jun 2019
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. Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving vaccine therapy together with aldesleukin may be a more effective treatment for metastatic breast cancer.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with aldesleukin works in treating women with metastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the efficacy of allogeneic large multivalent immunogen (LMI) vaccine and aldesleukin, as defined by clinical benefit rate (percentage of patients demonstrating a complete response, partial response, or disease stabilization as assessed by RECIST criteria), in women with stable metastatic breast cancer.
Secondary
- To measure the immune response in patients treated with this regimen.
- To determine the progression-free survival of patients treated with this regimen.
- To determine the 1- and 2-year overall survival rates in patients treated with this regimen.
- To determine the safety profile and toxicity of this regimen in these patients.
OUTLINE: Patients receive allogeneic large multivalent immunogen (LMI) vaccine intradermally on day 1 and aldesleukin subcutaneously on days 7 and 8. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 courses of vaccine therapy resume the chemotherapy regimen for which prior disease stabilization was achieved. Beginning 2-4 days after completion of chemotherapy, patients receive one dose of LMI vaccine followed by aldesleukin on days 7 and 8. Patients achieving at least stable disease continue to receive LMI vaccine and aldesleukin as above. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Peripheral blood mononuclear cell samples are collected periodically for research studies. Samples are analyzed to assess the frequency of leukocyte subsets (including B cells, T cells, NK cells, and monocytes) via flow cytometry; frequency of T-regs (T cells that express CD4, CD25, and FoxP3); and responses to keyhole limpet hemocyanin and tetanus toxoid via ELISA assay. Other immunological studies are also performed.
After completion of study therapy, 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 |
|---|---|---|
| LMI Vaccination + IL-2 | Experimental | Biological: allogeneic large multivalent immunogen breast cancer vaccine, Biological: aldesleukinPatients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Stage IV, metastatic breast cancer, confirmed by histology or cytology.
- Prior systemic chemotherapy, immunotherapy, biological therapy, or investigational drug therapy is allowed if at least 4 weeks since last treatment.
- Disease status may be measurable or non-measurable
- Karnofsky performance status >70%
- Women, age 18 years or older
Key exclusion criteria (9 listed)
- History of untreated or active brain metastases or positive brain scan at enrollment. Patients with previously treated brain metastases are eligible if stable by CT or MRI for at least 3 months.
- Concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
- Active infection
- Solid organ transplantation or autoimmune diseases requiring systemic immunosuppressive therapy; however, topical or inhalational steroids are allowed.
- Symptomatic pulmonary disease (symptoms of dyspnea or rales, wheezes or rhonchi on physical exam) will require pulmonary function testing (PFTs). Those with FEV1 <50% of predicted or corrected DLCO <50% are not eligible.
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 |
|---|---|---|
| allogeneic large multivalent immunogen breast cancer vaccineAlso: LMIAllogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml. | Biological | LMI Vaccination + IL-2 |
| aldesleukinAlso: Interleukin-2, IL-2, ProleukinSubcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection. | Biological | LMI Vaccination + IL-2 |
Primary outcome
Disease Response
Time frame: Up to 2 years
Percentage of patients achieving complete response, partial response, or disease stabilization as assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) criteria for measurable target lesions and non-measurable non-target lesions assessed by CT, PET-CT or MRI: Complete Response (CR), Disappearance of all target and non-target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions or persistence of one or more non-target lesions; Disease Stabilization (SD), Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease; Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
4 secondary outcomes
Immune Response
Time frame: 48 hours
Progression-free Survival
Time frame: Up to 1 year
Overall Survival
Time frame: 1 Year
Overall Survival
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 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Douglas Yee, MD principal investigator
Masonic Cancer Center, University of Minnesota
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 allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota 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 20 inclusion and 9 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: stopped early, as of the sponsor's last update on 6 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2019). 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?
Disease Response (time frame: Up to 2 years). 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 6 Jun 2019.