Pre-Operative, Single-Dose Ipilimumab and/or Cryoablation in Early Stage/Resectable Breast Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT01502592
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cryoablation — PROCEDURE
    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.\*
  • Ipilimumab — BIOLOGICAL
    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 Details

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.

Key Dates

Start date
Dec 31, 2011
Status verified
Jan 2016
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
19 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cryoablation alone
    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.
  • Experimental: Ipilimumab alone
    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.
  • Experimental: Ipilimumab & Cryoablation
    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.

Primary Outcome Measure

safety [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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