Breast CancerPhase 1NCT01502592
Pre-Operative, Single-Dose Ipilimumab and/or Cryoablation in Early Stage/Resectable Breast Cancer
A Phase 1 study testing Cryoablation and Ipilimumab in people with Breast Cancer and Invasive Adenocarcinoma of the Breast, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study is being done to evaluate the safety of two strategies called "cryoablation" and "immune therapy" in women with curable early stage breast cancer. "Cryoablation" is a procedure performed by an expert doctor called a radiologist. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Invasive Adenocarcinoma of the Breast
- What is being tested?
- Cryoablation and Ipilimumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age 18 years or older
- Confirmed histologic diagnosis of invasive adenocarcinoma of the breast, including MSKCC pathology confirmation
- ER, PR and HER2 testing in progress(i.e. on outside or MSKCC biopsy report)
- HER2-positive pathology is permitted
- Operable tumor measuring ≥1.5 cm in maximal diameter
- Any nodal status
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- Multifocal and multicentric disease is permitted.
- Synchronous bilateral invasive breast cancer is permitted
- No indication of distant metastases
- Total mastectomy planned
- Tumor amenable to cryoablation as determined by radiologist
- ECOG performance status score of 0 or 1
- Screening laboratory values must meet the following criteria:
- White blood cells (WBCs) ≥ 2000/μL
- Absolute neutrophil count (ANC) ≥ 1500/μL
- Platelets ≥ 100 x 103/μL
- Hemoglobin ≥ 11.0 g/dL
- Serum creatinine ≤ 2 mg/dL (or glomerular filtration rate ≥ 40 ml/min)
- AST ≤ 2.5 x upper limit of normal (ULN)
- ALT ≤ 2.5 x ULN
- Bilirubin within normal limits (except subjects with Gilbert's syndrome, who must have total bilirubin < 3.0 mg/dL)
- Negative HIV screening test
- Negative screening tests for Hepatitis B and Hepatitis C.
- Patients with positive results that do not indicate true active or chronic infection may enroll after discussion and consensus agreement by the treating physician and principal investigator.
- Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study and for at least 3 months after the last dose of ipilimumab in such a manner that the risk of pregnancy is minimized. See below for the definition of WOCBP.
- WOCBP must have a negative serum pregnancy test within 14 days of the first study intervention.
- Women must not be breastfeeding.
- Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
- Definition of WOCBP
- Women of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined as:
- Amenorrhea ≥ 12 consecutive months without another cause and a documented serum follicle stimulating hormone (FSH) level >35 mIU/mL
- Women with irregular menstrual periods and a documented FSH level > 35 mIU/mL
- Women on hormone replacement therapy (HRT) Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential.
Who cannot join
- Inflammatory breast cancer
- Medical history and concurrent diseases
- Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study as are subjects with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]). Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome) are excluded from this study.
- Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs, such as a condition associated with frequent or poorly controlled diarrhea.
- Prohibited Treatments and/or Therapies
- Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses). However, use of corticosteroids is allowed for the treatment of immune related Adverse Events (irAEs), or adrenal insufficiency.
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- Any non-oncology vaccine therapy used for prevention of infectious diseases within 4 weeks prior to first dose of ipilimumab.
- Prior treatment with a CD137 agonist, ipilimumab or other CTLA4 inhibitor;
- Prior investigational agents within 4 weeks prior to first dose of ipilimumab;
- Prior therapy with any anti-cancer agents including chemotherapy, adjuvant chemotherapy, immunosuppressive agents, surgery or radiotherapy within 4 weeks prior to first dose of ipilimumab.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: A Pilot Study of Pre-Operative, Single-Dose Ipilimumab and/or Cryoablation in Early Stage/Resectable Breast Cancer
This study is being done to evaluate the safety of two strategies called "cryoablation" and "immune therapy" in women with curable early stage breast cancer. "Cryoablation" is a procedure performed by an expert doctor called a radiologist. The radiologist uses (magnetic resonance imaging (MRI) to insert a needle directly into a cancer. Very cold temperatures are then applied through the needle to kill the cancer cells. Some of the killed cancer cells will be broken into pieces that can be recognized by a person's immune system.
The "immune therapy" in this study is a drug called ipilimumab. Normally the immune system makes "T cells" that can kill cancer cells when turned on. The cancer-killing T cell activity is controlled by a molecule called CTLA4. Ipilimumab works by turning off CTLA4. Turning off CTLA4 allows the cancer-fighting T cells to remain active Ipilimumab is an antibody drug has been made in a laboratory for patient use and was recently approved by the United States Food and Drug Administration (FDA) for the treatment of patients with a type of skin cancer called melanoma. An antibody is a normal protein that the immune system uses to find and kill germs like bacteria and viruses. This study is being done because the researchers believe that when cryoablation is combined with immune therapy, a person's immune system can be trained to recognize that person's cancer. This may prevent that cancer from coming back in the future. In other words, it is hoped that by adding cryoablation with ipilimumab before the mastectomy, the body will remain cancer free long after the mastectomy is performed. The first step in determining whether cryoablation and immune therapy can be used to cure breast cancer is to evaluate the safety of each strategy alone and then in combination in a small group of patients.
- Being tested
- Cryoablation, Ipilimumab
- Keywords
- MDX-010 (Ipilimumab), Cryoablation, Total mastectomy planned, 11-202
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
OncCore Biopsy (+ Cryo) Date*
- Pre- and post- cryo MRI
- Core biopsy x ≥3
- Cryoablation Optional pre-surgery MRI day prior or day of Mastectomy Date* Safety assessment 30 (+/-10) days after surgery research bloods 30 (+/-10) days after surgery.*
IpilimumabBiological
Ipilimumab Appt. with Med Onc Ipilimumab administered Core Biopsy Date*
- MRI
- Core biopsy x ≥3 Optional pre-surgery MRI biopsy prior or day of Mastectomy Date* Safety assessment 2-3 weeks post-mastectomy (co-ordinated with off-study surgery follow-up appt if feasible) and then every 2-3 weeks thereafter until at least 12 weeks post ipilimumab date. # Research bloods 30 (+/-10) days after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation alone | Experimental | This is a pilot study evaluating the safety and tolerability of pre-operative, single-dose ipilimumab and/or cryoablation in patients with early stage/resectable breast cancer. Receives: Procedure: Cryoablation |
| Ipilimumab alone | Experimental | This is a pilot study evaluating the safety and tolerability of pre-operative, single-dose ipilimumab and/or cryoablation in patients with early stage/resectable breast cancer. Receives: Biological: Ipilimumab |
| Ipilimumab & Cryoablation | Experimental | This is a pilot study evaluating the safety and tolerability of pre-operative, single-dose ipilimumab and/or cryoablation in patients with early stage/resectable breast cancer. Receives: Procedure: Cryoablation; Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
of pre-operative ipilimumab administration and intratumoral cryoablation administered either alone or in combination in patients with early stage breast cancer. Safety will be evaluated for all treated subjects using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Measured: 1 year
tolerability
If 5 of the 6 patients in study arm A and 5 of the 6 patients in study arm B are without an AE necessitating delay in surgery, we will enroll 6 additional patients into study arm C. If 5 or 6 of these 6 patients in study arm C are without an AE necessitating delay in surgery, the regimen will be considered safe/tolerable for further study. Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Measured: 1 year
Secondary outcomes (1)
Efficacy
exploratory correlative studies will be performed to evaluate anti-tumor and immunological response pre- and post-treatment in individuals. Comparisons with other study participants will also be conducted. Breast cancer tissue specimens, axillary lymph nodes specimens where available, and peripheral blood samples will be studied.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather McArthur, MD, MPH, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502592
- Sponsor's protocol ID
- 11-202
- Status last verified
- Jan 2016
- First submitted
- 29 Dec 2011
- Last updated
- 5 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Pre-Operative, Single-Dose Ipilimumab and/or Cryoablation in Early Stage/Resectable Breast Cancer
- ClinicalTrials.gov ID
- NCT01502592
- Acronym / sponsor ID
- 11-202
- Keywords
- MDX-010 (Ipilimumab), Cryoablation, Total mastectomy planned, 11-202
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Dec 2011 (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 study is being done to evaluate the safety of two strategies called "cryoablation" and "immune therapy" in women with curable early stage breast cancer. "Cryoablation" is a procedure performed by an expert doctor called a radiologist. The radiologist uses (magnetic resonance imaging (MRI) to insert a needle directly into a cancer. Very cold temperatures are then applied through the needle to kill the cancer cells. Some of the killed cancer cells will be broken into pieces that can be recognized by a person's immune system.
The "immune therapy" in this study is a drug called ipilimumab. Normally the immune system makes "T cells" that can kill cancer cells when turned on. The cancer-killing T cell activity is controlled by a molecule called CTLA4. Ipilimumab works by turning off CTLA4. Turning off CTLA4 allows the cancer-fighting T cells to remain active Ipilimumab is an antibody drug has been made in a laboratory for patient use and was recently approved by the United States Food and Drug Administration (FDA) for the treatment of patients with a type of skin cancer called melanoma. An antibody is a normal protein that the immune system uses to find and kill germs like bacteria and viruses. This study is being done because the researchers believe that when cryoablation is combined with immune therapy, a person's immune system can be trained to recognize that person's cancer. This may prevent that cancer from coming back in the future. In other words, it is hoped that by adding cryoablation with ipilimumab before the mastectomy, the body will remain cancer free long after the mastectomy is performed. The first step in determining whether cryoablation and immune therapy can be used to cure breast cancer is to evaluate the safety of each strategy alone and then in combination in a small group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cryoablation alone | Experimental | Procedure: CryoablationThis is a pilot study evaluating the safety and tolerability of pre-operative, single-dose ipilimumab and/or cryoablation in patients with early stage/resectable breast cancer. |
| Ipilimumab alone | Experimental | Biological: IpilimumabThis is a pilot study evaluating the safety and tolerability of pre-operative, single-dose ipilimumab and/or cryoablation in patients with early stage/resectable breast cancer. |
| Ipilimumab & Cryoablation | Experimental | Procedure: Cryoablation, Biological: IpilimumabThis is a pilot study evaluating the safety and tolerability of pre-operative, single-dose ipilimumab and/or cryoablation in patients with early stage/resectable breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Women age 18 years or older
- Confirmed histologic diagnosis of invasive adenocarcinoma of the breast, including MSKCC pathology confirmation
- ER, PR and HER2 testing in progress(i.e. on outside or MSKCC biopsy report)
- HER2-positive pathology is permitted
- Operable tumor measuring ≥1.5 cm in maximal diameter
Key exclusion criteria (10 listed)
- Inflammatory breast cancer
- Medical history and concurrent diseases
- Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study as are subjects with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]). Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome) are excluded from this study.
- Any underlying medical or psychiatric condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of AEs, such as a condition associated with frequent or poorly controlled diarrhea.
- Prohibited Treatments and/or Therapies
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 |
|---|---|---|
| CryoablationOncCore Biopsy (+ Cryo) Date* * Pre- and post- cryo MRI * Core biopsy x ≥3 * Cryoablation Optional pre-surgery MRI day prior or day of Mastectomy Date* Safety assessment 30 (+/-10) days after surgery research bloods 30 (+/-10) days after surgery.* | Procedure or surgery | Cryoablation alone, Ipilimumab & Cryoablation |
| IpilimumabIpilimumab Appt. with Med Onc Ipilimumab administered Core Biopsy Date* * MRI * Core biopsy x ≥3 Optional pre-surgery MRI biopsy prior or day of Mastectomy Date* Safety assessment 2-3 weeks post-mastectomy (co-ordinated with off-study surgery follow-up appt if feasible) and then every 2-3 weeks thereafter until at least 12 weeks post ipilimumab date. # Research bloods 30 (+/-10) days after surgery. | Biological | Ipilimumab & Cryoablation, Ipilimumab alone |
Primary outcome
safety
Time frame: 1 year
of pre-operative ipilimumab administration and intratumoral cryoablation administered either alone or in combination in patients with early stage breast cancer. Safety will be evaluated for all treated subjects using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
tolerability
Time frame: 1 year
If 5 of the 6 patients in study arm A and 5 of the 6 patients in study arm B are without an AE necessitating delay in surgery, we will enroll 6 additional patients into study arm C. If 5 or 6 of these 6 patients in study arm C are without an AE necessitating delay in surgery, the regimen will be considered safe/tolerable for further study. Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
1 secondary outcome
Efficacy
Time frame: 1 year
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 5 Jan 2016.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather McArthur, MD, MPH principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cryoablation and Ipilimumab in people with Breast Cancer and Invasive Adenocarcinoma of the Breast, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 33 inclusion and 10 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 5 Jan 2016. 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?
safety (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.