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Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers

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ClinicalTrials.gov Identifier: NCT01856036
Recruitment Status : Terminated (PI left institute and contacted IRB to close study.)
First Posted : May 17, 2013
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
John Wayne Cancer Institute

Tracking Information
First Submitted Date  ICMJE April 18, 2013
First Posted Date  ICMJE May 17, 2013
Last Update Posted Date February 7, 2017
Actual Study Start Date  ICMJE April 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2013)
Characterization of the intra-tumoral and systemic immune response to cryoablation in invasive breast cancers [ Time Frame: 12 Months ]
  1. Determine number (percentage via flow cytometry), phenotype and functionality of tumor infiltrating lymphocytes in ablated breast cancer
  2. Determine number (percentage via flow cytometry)and phenotype of APC in ablated breast cancer
  3. Characterize cytokine and chemokine expression (in IU) in ablated tissue and in pre-ablated and post-ablated serum over time
  4. Quantify T cell response (IUs of IL2 and IFN gamma, and T cell specific cells as measured by number of spots on an elispot assay) to tumor associated antigens using in vitro assays of T cell proliferation and function (cytokine release, elispot, peptide-MHC)
  5. Determine morphology and histology of regional lymph node after cryoablation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2013)
Comparison of the intra-tumoral and systemic response between non-ablated and ablated breast cancer and pre-ablated and post ablated serum [ Time Frame: 24 Months ]
  1. Difference in intra-tumoral lymphocyte populations (percentage via flow cytometry) in ablated and non-ablated breast cancers
  2. Compare serum cytokine and chemokine expression (in IU) between patients undergoing or not undergoing tumor ablation
  3. Compare intra-tumoral lymphocyte populations (percentage via flow cytometry) in ablated tumor tissue with paraffin embedded specimens for tumors that are matched for age, tumor size and histology.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
Official Title  ICMJE CHUM-CRYOABLATION: Anti-Tumor Immunity Induced by Cryoablation of Invasive Breast Cancers
Brief Summary This protocol will study the impact of cryoablation on immune response in patients diagnosed with invasive breast cancers smaller than 1.5 cm. It will profile the immune response to cryoablation of invasive breast cancers. The intra-tumoral and systemic immune response to cryoablation will be determined and compared to pre-ablated breast cancer specimens and historical control specimens.
Detailed Description Patients with small breast cancers will undergo cryoablation of their breast cancer. Approximately six weeks after cryoablation, definitive breast surgery will be performed. Blood will be drawn for research before cryoablation and surgery and at regular follow-up visits. Blood and tissue samples will be used to determine immune responses.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Procedure: Cryoablation
Cryoablation of breast cancer will be performed using a freeze-thaw technique and an IceCure probe. Cryoablation cycles will be determined by IceCure software programmed by the treating surgeon.
Study Arms  ICMJE Experimental: Cryoablation
Cryoablation of breast cancer will be performed using a freeze-thaw technique and an IceCure probe. Cryoablation cycles will be determined by IceCure software programmed by the treating surgeon.
Intervention: Procedure: Cryoablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 10, 2014)
2
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2013)
20
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects with an invasive breast cancer 1.5 cm or less
  2. The breast cancer must be of ductal histology, unifocal, estrogen receptor positive and her2/neu negative.
  3. The tumor must be visible by ultrasound and the subject must not have had prior surgical resection of the primary lesion.
  4. A clip marking the breast cancer must have been placed at the time of initial diagnosis or will be placed prior to cryotherapy.
  5. The breast cancer must be amenable to cryoablation (visible by ultrasound and more than 2 mm from skin or chest wall).
  6. Subjects with metastatic disease at diagnosis who elect to have their primary tumor excised are eligible for enrollment.
  7. For subjects with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion with not contact or jeopardize the implant.
  8. Subjects must be able to provide consent.

Exclusion Criteria:

  1. Subjects with breast cancers of lobular histology, with lymph vascular invasion or extensive intraductal component will be excluded.
  2. Subjects with multi-centric or multi-focal breast cancers
  3. Subjects with breast cancers that have invaded skin or have significant skin tethering (assessed clinically).
  4. Subjects receiving chemotherapy within one year or undergoing neoadjuvant chemotherapy are excluded.
  5. Subjects with metastatic disease at diagnosis will be excluded unless they elect definitive surgical therapy for their primary lesion.
  6. Subjects with breast cancers not amenable to cryoablation (lesions not visible by ultrasound, against the chest wall or within 2 mm of skin) will be excluded.
  7. Subjects diagnosed with another malignancy in the preceding 5 years will be excluded.
  8. Subjects diagnosed with simultaneous bilateral breast cancer.
  9. Subjects receiving immunosuppressive therapy within 6 months including oral steroids will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01856036
Other Study ID Numbers  ICMJE CHUM-CRYOABLATION
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party John Wayne Cancer Institute
Study Sponsor  ICMJE John Wayne Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account John Wayne Cancer Institute
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP