Clinical trial NCT03039127: Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer
Official title: Interstitial Laser Thermotherapy (imILT) as a Treatment Option in Breast Cancer Patients Not Suitable for Surgical Excision
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Hyperthermia
Laser Coagulation
Laser Therapy
Induced
Lead sponsor: Clinical Laserthermia Systems AB
Sponsor class: INDUSTRY
Collaborators: name: Nottingham University Hospitals NHS Trust
First posted: 2017-02-01
Enrollment: 3
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size. The immunologic response has previously been characterized in breast cancer patients after receiving imILT treatment , and presumed abscopal effects induced by imILT have also been described in a malignant melanoma patient.

The purpose of this trial is to investigate the functionality and safety of the imILT treatment method in patients diagnosed with breast cancer.

The treatment method has successfully been used for treatment of patients with breast cancer and malignant melanoma. Treatment of breast cancer patients caused an increase of cytotoxic T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border. Regulatory T lymphocytes decreased in the regional lymph nodes.

This trial is explorative, prospective, open and non-randomized. Five breast cancer patients will be treated in this trial, which is estimated to be carried out during a time period of 9 months.


Eligibility criteria: Inclusion Criteria:

1. Have histologically confirmed breast cancer
2. Hormone receptor positive or negative
3. Have assessable tumour by MRI or ultrasound
4. Are patients deemed unfit for surgical excision of tumour under general anaesthetic.
5. Have been given informed verbal and written consent for participation in the trial
6. Have stable hematologic, renal and hepatic functions.

Exclusion Criteria:

1. Are known to be HIV positive
2. Have active autoimmune disease
3. Are on corticosteroid medication
4. Have evidence of bleeding diathesis or coagulopathy.

Primary outcomes:
measure: Treatment effect by radiology
timeFrame: 9 months
Secondary outcomes:
measure: Safety (adverse events)
timeFrame: 9 months
measure: Usability (user evaluation of instrument)
timeFrame: 9 months
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham Breast Cancer Institute
Study officials:
affiliation: Nottingham Breast Institute
name: Kristjan S Asgeirsson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haraldsdottir KH, Ingvar C, Stenram U, Tranberg KG. Long-term Follow-up After Interstitial Laser Thermotherapy of Breast Cancer. Anticancer Res. 2015 Nov;35(11):6147-52.
citation: Haraldsdottir KH, Ivarsson K, Jansner K, Stenram U, Tranberg KG. Changes in immunocompetent cells after interstitial laser thermotherapy of breast cancer. Cancer Immunol Immunother. 2011 Jun;60(6):847-56. doi: 10.1007/s00262-011-0992-8. Epub 2011 Mar 13.
citation: Ivarsson K, Myllymaki L, Jansner K, Stenram U, Tranberg KG. Resistance to tumour challenge after tumour laser thermotherapy is associated with a cellular immune response. Br J Cancer. 2005 Aug 22;93(4):435-40. doi: 10.1038/sj.bjc.6602718.
citation: Tranberg KG, Moller PH, Hannesson P, Stenram U. Interstitial laser treatment of malignant tumours: initial experience. Eur J Surg Oncol. 1996 Feb;22(1):47-54. doi: 10.1016/s0748-7983(96)91451-1.
citation: Tranberg KG, Myllymaki L, Moller PH, Ivarsson K, Sjogren HO, Stenram U. Interstitial laser thermotherapy of a rat liver adenocarcinoma. J Xray Sci Technol. 2002 Jan 1;10(3):177-85.
citation: Ivarsson K, Myllymaki L, Jansner K, Bruun A, Stenram U, Tranberg KG. Heat shock protein 70 (HSP70) after laser thermotherapy of an adenocarcinoma transplanted into rat liver. Anticancer Res. 2003 Sep-Oct;23(5A):3703-12.