Metastatic Breast CancerPhase 1/2MBCNCT02018419
Increased Frequency of AlloStim(TM) Dosing in Combination With Cryoablation in Metastatic Breast Cancer Patients
A Phase 1/2 study testing AlloStim and Cryoablation in people with Metastatic Breast Cancer, run by Mirror Biologics, Inc. at 1 site in United States.
Trial summary
This phase I/II study is designed to compare different treatment schedules of a personalized anti-cancer vaccine protocol which combines the cryoablation of a selected metastatic lesion with intra-tumor immunotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- AlloStim and Cryoablation
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2014
- Phase
- Phase 1/2
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women w/ histologically/cytologically confirmed breast carcinoma
- Documented progressive metastatic disease not amenable to curative surgery/radiotherapy
- Age ≥18 and ≤70 years
- Prior treatments that included capecitabine and both an anthracycline and a taxane drug and resistant to taxane therapy
- ER+ patients: minimum cumulative dose of anthracycline (≥ 180 mg/m² of doxorubicin or ≥ 300 mg/m² of epirubicin) or resistance to anthracycline, capecitabine and anti-hormonal therapy
- Resistance is defined as tumor progression while receiving treatment or progression within 4 months of the last dose in the metastatic setting, or recurrence within 12 months in the neoadjuvant/adjuvant setting
Show all 26Show fewer
- Post-menopausal ER+ and/or PR+ must have received at least 2 lines of prior anti-estrogen therapy, which includes an aromatase inhibitor
- Her2+ patients: at least 1 Her2+ targeted regimen containing trastuzumab alone or with pertuzumab/lapatinib. Trastuzumab/pertuzumab must have been discontinued at least 4 weeks before treatment
- Prior radiation therapy completed >4 weeks before treatment
- Measurable disease according to revised RECIST v.1.1 guidelines with at least 1 lesion deemed to be safely accessible for serial biopsy
- ECOG <2
- Adequate hematological function
- Absolute granulocyte count ≥ 1,500/mm3
- Platelet count ≥ 100,000/mm3
- PT/INR ≤ 1.5
- INR correctable to ≤ 1.5 or a PT/PTT correctable to normal limits. Patients receiving anti-coagulation treatment with agent such as warfarin/heparin may participate. For patients on warfarin, INR should be monitored weekly prior to any intervention to assure INR is stable. Heparin/warfarin must be withheld before biopsy
- Hemoglobin ≥ 9 g/dL (may be corrected by transfusion)
- Adequate organ function
- Creatinine ≤ 1.5 mg/dL
- Total bilirubin ≤ 1.5 times ULN
- Alkaline phosphatase≤2.5 times ULN (≤5 times normal if liver involvement)
- Aspartate aminotransferase (AST/SGOT) ≤ 5.0 times ULN
- Alanine aminotransferase (ALT/SGPT) ≤ 5.0 times ULN
- EKG without clinically relevant abnormalities
- Pre-menopausal with child bearing potential subjects must use adequate contraception
- Informed consent in the native language of the subject
Who cannot join
- Peritoneal carcinomatosis
- Moderate-large ascites accumulation requiring/likely to require paracentesis
- Clinical/radiological evidence of brain metastasis/leptomeningeal involvement
- Pulmonary lymphangitis/symptomatic pleural effusion (grade ≥ 2) that results in pulmonary dysfunction requiring active treatment
- History of 2nd primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non-melanomatous carcinoma of the skin, and other malignancy treated at least 5 years with no evidence of recurrence
- >3 prior chemotherapy regimens for metastatic disease
Show all 26Show fewer
- History of severe hypersensitivity to monoclonal antibody drugs/any contraindication to study drugs
- Pregnant or breast feeding
- Any serious, concurrent uncontrolled medical disorder
- Prior hepatectomy, liver chemoembolization, liver cryoablation/ radiofrequency ablated
- Symptomatic pulmonary disease
- Bevacizumab (Avastin®) within 3 weeks of accrual
- Prior allogeneic bone marrow/stem cell or solid organ transplant
- Chronic use (> 2 weeks) of greater than physiologic doses of corticosteroid agent (dose equivalent to > 10 mg/day of prednisone) within 30 days of the first day of study treatment. Topical and inhaled corticosteroids are permitted
- Concomitant active autoimmune disease
- Prior experimental therapy/cancer vaccine treatment
- Current immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 1 month of study entry
- History of blood transfusion reactions
- Known allergy to bovine products
- Know allergy to murine products
- Progressive viral/bacterial infection. All infections must be resolved and the patient must remain afebrile for 7days without antibiotics prior to enrollment
- Cardiac disease of symptomatic nature or cardiac ejection fraction < 45%
- History of HIV positivity or AIDS
- Psychiatric/addictive disorders or other condition that, in the opinion of the investigator, would preclude study participation
- Concurrent medication known to interfere with platelet function or coagulation (e.g., aspirin, ibuprofen, clopidogrel, or warfarin) unless can be discontinued for an appropriate time period based on the drug half-life and known activity (e.g., aspirin for 7 days) prior to cryoablation procedure
- Use of low molecular weight heparin preparations unless can be discontinued 8 hours prior to cryoablation
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Oncology Associates of San Diego
San Diego, California, 92123
About this study
Official title: In-Situ Cancer Vaccine: Phase I/IIb, Open-Label Study to Assess Safety of AllostimTM in Combination With Cryoablation in Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane and Capecitabine
This phase I/II study is designed to compare different treatment schedules of a personalized anti-cancer vaccine protocol which combines the cryoablation of a selected metastatic lesion with intra-tumor immunotherapy. The cryoablation causes the tumor to release tumor-specific antigens into the surrounding environment. The injection of bioengineered allogeneic immune cells, AlloStim(TM), into the lesion is designed to modulate the immune response and educate the immune system to kill other tumor cells.
Read the detailed description
The study will assess three different dosing schedules. A standard 3 plus 3 study design will be used. The starting dose for each dosing schedule will be escalated in subsequent groups of patients. The study will evaluate safety of increased frequency of AlloStim (TM) dosing and anti-tumor effect of the new proposed dose and frequency schedule.
- Conditions
- Metastatic Breast Cancer
- Being tested
- AlloStim, Cryoablation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlloStimBiological
Also called InSituVax, Personalized anti-tumor vaccine
AlloStim is derived from the blood of normal blood donors and is intentionally mismatched to the recipient.
CryoablationProcedure or surgery
Percutaneous ablation of a single metastatic tumor lesion usually in liver or bone. The procedure is conducted under CT or ultrasound image-guidance.
| Study group | Role | What they receive |
|---|---|---|
| Dosing Schedule A | Experimental | 1. the priming step with ID injection of AlloStim on Days 0, 7, and 14;
2. the ablation step with cryoablation and intra-tumor injection of AlloStim on Day 21;
3. the activation step with an IV infusion of AlloStim on Day 28;
4. the booster step with intravenous booster infusion of AlloStim on Days 56 and 84;
Protocol follow-up procedures continue until day 168 and at investigator discretion thereafter. Receives: Biological: AlloStim; Procedure: Cryoablation |
| Dosing Schedule B | Experimental | 1. the priming step with ID injection of AlloStim on Days 0 and 3 and an additional ID injection of AlloStim on Days 7 and 10;
2. the ablation step with cryoablation and intra-tumor injection of AlloStim on Day 14;
3. the activation step with an IV infusion of AlloStim on Day 21;
4. the booster step with intravenous booster infusion of AlloStim on Days 49 and 77.
Protocol follow-up procedures continue until day 168 and at investigator discretion thereafter. Receives: Biological: AlloStim; Procedure: Cryoablation |
| Dosing Schedule C | Experimental | 1. the priming step with ID injection of AlloStim on Days 0 and 3 and an additional ID injection of AlloStim on Days 7 and 10;
2. the ablation step with cryoablation and intra-tumor injection of AlloStim on Day 14, and intra-tumor injection of AlloStim again into the same cryoablated lesion on Day 17;
3. the activation step with an IV infusion of AlloStim on Day 21;
4. the booster step with intravenous infusion of AlloStim on days 49 and 77.
Protocol follow-up procedures continue until day 168 and at investigator discretion thereafter. Receives: Biological: AlloStim; Procedure: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of increased frequency of dosing
Three patients are enrolled at each frequency schedule in the absence of dose limiting toxicity (DLT). A DLT is defined as any allergic or autoimmune toxicity or other study drug related toxicity Grade 3 or higher during the DLT assessment window.
Measured: Window is defined as the time required receiving two doses of AlloStim IV push plus 28 days follow-up
Secondary outcomes (2)
Health-Related Quality of Life
Health-Related Quality of life will be measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) and its supplementary breast cancer questionnaire (QLQ-BR23).
Measured: From enrollment to 90 days after last dose administration.
Evaluate the anti-tumor effect of Allostim combined with cryoablation at the new proposed dose and frequency schedule.
Each treatment schedule will be monitored for radiological, pathological, and immunological response. These assessments will be compared between three treatment schedules.
Measured: 90 days after last dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startMar 2014
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: changing indication from breast cancer to metastatic colorectal cancer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Metastatic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirror Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zivile Katiliene, Ph.D., Study director, Immunovative Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018419
- Sponsor's protocol ID
- ITL-014-TACT-MBC
- Acronym
- MBC
- Status last verified
- Apr 2015
- First submitted
- 17 Dec 2013
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Har-Noy M, Slavin S. The anti-tumor effect of allogeneic bone marrow/stem cell transplant without graft vs. host disease toxicity and without a matched donor requirement? Med Hypotheses. 2008;70(6):1186-92. doi: 10.1016/j.mehy.2007.10.008. Epub 2007 Dec 3.
PubMed 18054441Har-Noy M, Zeira M, Weiss L, Slavin S. Completely mismatched allogeneic CD3/CD28 cross-linked Th1 memory cells elicit anti-leukemia effects in unconditioned hosts without GVHD toxicity. Leuk Res. 2008 Dec;32(12):1903-13. doi: 10.1016/j.leukres.2008.05.007. Epub 2008 Jun 18.
PubMed 18565579Har-Noy M, Zeira M, Weiss L, Fingerut E, Or R, Slavin S. Allogeneic CD3/CD28 cross-linked Th1 memory cells provide potent adjuvant effects for active immunotherapy of leukemia/lymphoma. Leuk Res. 2009 Apr;33(4):525-38. doi: 10.1016/j.leukres.2008.08.017. Epub 2008 Oct 1.
PubMed 18834631Janikashvili N, LaCasse CJ, Larmonier C, Trad M, Herrell A, Bustamante S, Bonnotte B, Har-Noy M, Larmonier N, Katsanis E. Allogeneic effector/memory Th-1 cells impair FoxP3+ regulatory T lymphocytes and synergize with chaperone-rich cell lysate vaccine to treat leukemia. Blood. 2011 Feb 3;117(5):1555-64. doi: 10.1182/blood-2010-06-288621. Epub 2010 Dec 1.
PubMed 21123824LaCasse CJ, Janikashvili N, Larmonier CB, Alizadeh D, Hanke N, Kartchner J, Situ E, Centuori S, Har-Noy M, Bonnotte B, Katsanis E, Larmonier N. Th-1 lymphocytes induce dendritic cell tumor killing activity by an IFN-gamma-dependent mechanism. J Immunol. 2011 Dec 15;187(12):6310-7. doi: 10.4049/jimmunol.1101812. Epub 2011 Nov 9.
PubMed 22075702
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Situ Cancer Vaccine: Phase I/IIb, Open-Label Study to Assess Safety of AllostimTM in Combination With Cryoablation in Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane and Capecitabine
- ClinicalTrials.gov ID
- NCT02018419
- Acronym / sponsor ID
- MBC / ITL-014-TACT-MBC
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: changing indication from breast cancer to metastatic colorectal cancer
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mirror Biologics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 23 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 phase I/II study is designed to compare different treatment schedules of a personalized anti-cancer vaccine protocol which combines the cryoablation of a selected metastatic lesion with intra-tumor immunotherapy. The cryoablation causes the tumor to release tumor-specific antigens into the surrounding environment. The injection of bioengineered allogeneic immune cells, AlloStim(TM), into the lesion is designed to modulate the immune response and educate the immune system to kill other tumor cells.
Detailed description
The study will assess three different dosing schedules. A standard 3 plus 3 study design will be used. The starting dose for each dosing schedule will be escalated in subsequent groups of patients. The study will evaluate safety of increased frequency of AlloStim (TM) dosing and anti-tumor effect of the new proposed dose and frequency schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dosing Schedule A | Experimental | Biological: AlloStim, Procedure: Cryoablation1. the priming step with ID injection of AlloStim on Days 0, 7, and 14; 2. the ablation step with cryoablation and intra-tumor injection of AlloStim on Day 21; 3. the activation step with an IV infusion of AlloStim on Day 28; 4. the booster step with intravenous booster infusion of AlloStim on Days 56 and 84; Protocol follow-up procedures continue until day 168 and at investigator discretion thereafter. |
| Dosing Schedule B | Experimental | Biological: AlloStim, Procedure: Cryoablation1. the priming step with ID injection of AlloStim on Days 0 and 3 and an additional ID injection of AlloStim on Days 7 and 10; 2. the ablation step with cryoablation and intra-tumor injection of AlloStim on Day 14; 3. the activation step with an IV infusion of AlloStim on Day 21; 4. the booster step with intravenous booster infusion of AlloStim on Days 49 and 77. Protocol follow-up procedures continue until day 168 and at investigator discretion thereafter. |
| Dosing Schedule C | Experimental | Biological: AlloStim, Procedure: Cryoablation1. the priming step with ID injection of AlloStim on Days 0 and 3 and an additional ID injection of AlloStim on Days 7 and 10; 2. the ablation step with cryoablation and intra-tumor injection of AlloStim on Day 14, and intra-tumor injection of AlloStim again into the same cryoablated lesion on Day 17; 3. the activation step with an IV infusion of AlloStim on Day 21; 4. the booster step with intravenous infusion of AlloStim on days 49 and 77. Protocol follow-up procedures continue until day 168 and at investigator discretion thereafter. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Women w/ histologically/cytologically confirmed breast carcinoma
- Documented progressive metastatic disease not amenable to curative surgery/radiotherapy
- Age ≥18 and ≤70 years
- Prior treatments that included capecitabine and both an anthracycline and a taxane drug and resistant to taxane therapy
- Post-menopausal ER+ and/or PR+ must have received at least 2 lines of prior anti-estrogen therapy, which includes an aromatase inhibitor
Key exclusion criteria (26 listed)
- Peritoneal carcinomatosis
- Moderate-large ascites accumulation requiring/likely to require paracentesis
- Clinical/radiological evidence of brain metastasis/leptomeningeal involvement
- Pulmonary lymphangitis/symptomatic pleural effusion (grade ≥ 2) that results in pulmonary dysfunction requiring active treatment
- History of 2nd primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non-melanomatous carcinoma of the skin, and other malignancy treated at least 5 years with no evidence of recurrence
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 |
|---|---|---|
| AlloStimAlso: InSituVax, Personalized anti-tumor vaccineAlloStim is derived from the blood of normal blood donors and is intentionally mismatched to the recipient. | Biological | Dosing Schedule A, Dosing Schedule B, Dosing Schedule C |
| CryoablationPercutaneous ablation of a single metastatic tumor lesion usually in liver or bone. The procedure is conducted under CT or ultrasound image-guidance. | Procedure or surgery | Dosing Schedule A, Dosing Schedule B, Dosing Schedule C |
Primary outcome
To determine the safety of increased frequency of dosing
Time frame: Window is defined as the time required receiving two doses of AlloStim IV push plus 28 days follow-up
Three patients are enrolled at each frequency schedule in the absence of dose limiting toxicity (DLT). A DLT is defined as any allergic or autoimmune toxicity or other study drug related toxicity Grade 3 or higher during the DLT assessment window.
2 secondary outcomes
Health-Related Quality of Life
Time frame: From enrollment to 90 days after last dose administration.
Evaluate the anti-tumor effect of Allostim combined with cryoablation at the new proposed dose and frequency schedule.
Time frame: 90 days after last dose administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Results publication: PubMed 18054441Har-Noy M, Slavin S. The anti-tumor effect of allogeneic bone marrow/stem cell transplant without graft vs. host disease toxicity and without a matched donor requirement? Med Hypotheses. 2008;70(6):1186-92. doi: 10.1016/j.mehy.2007.10.008. Epub 2007 Dec 3.
- Results publication: PubMed 18565579Har-Noy M, Zeira M, Weiss L, Slavin S. Completely mismatched allogeneic CD3/CD28 cross-linked Th1 memory cells elicit anti-leukemia effects in unconditioned hosts without GVHD toxicity. Leuk Res. 2008 Dec;32(12):1903-13. doi: 10.1016/j.leukres.2008.05.007. Epub 2008 Jun 18.
- Results publication: PubMed 18834631Har-Noy M, Zeira M, Weiss L, Fingerut E, Or R, Slavin S. Allogeneic CD3/CD28 cross-linked Th1 memory cells provide potent adjuvant effects for active immunotherapy of leukemia/lymphoma. Leuk Res. 2009 Apr;33(4):525-38. doi: 10.1016/j.leukres.2008.08.017. Epub 2008 Oct 1.
- Results publication: PubMed 21123824Janikashvili N, LaCasse CJ, Larmonier C, Trad M, Herrell A, Bustamante S, Bonnotte B, Har-Noy M, Larmonier N, Katsanis E. Allogeneic effector/memory Th-1 cells impair FoxP3+ regulatory T lymphocytes and synergize with chaperone-rich cell lysate vaccine to treat leukemia. Blood. 2011 Feb 3;117(5):1555-64. doi: 10.1182/blood-2010-06-288621. Epub 2010 Dec 1.
- Results publication: PubMed 22075702LaCasse CJ, Janikashvili N, Larmonier CB, Alizadeh D, Hanke N, Kartchner J, Situ E, Centuori S, Har-Noy M, Bonnotte B, Katsanis E, Larmonier N. Th-1 lymphocytes induce dendritic cell tumor killing activity by an IFN-gamma-dependent mechanism. J Immunol. 2011 Dec 15;187(12):6310-7. doi: 10.4049/jimmunol.1101812. Epub 2011 Nov 9.
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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.
Zivile Katiliene, Ph.D. study director
Immunovative Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AlloStim and Cryoablation in people with Metastatic Breast Cancer, run by Mirror Biologics, Inc. 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 26 inclusion and 26 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: withdrawn, as of the sponsor's last update on 22 Jan 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 combined 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
To determine the safety of increased frequency of dosing (time frame: Window is defined as the time required receiving two doses of AlloStim IV push plus 28 days follow-up). 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 NCT02018419, which also lists 5 linked publications.
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 22 Jan 2020.