Immunostimulating Interstitial Laser Thermotherapy in Breast Cancer

NCT03039127 | Terminated

• 1 other identifier: CTP-2015-009
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Hyperthermia; Laser Coagulation; Laser Therapy; Induced

Outcome Measures

Primary Outcomes (1)

• Treatment effect by radiology

  Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)

  9 months

Secondary Outcomes (2)

• Safety (adverse events)

  9 months

• Usability (user evaluation of instrument)

  9 months

Study Arms (1)

imILT

EXPERIMENTAL

Immunostimulating Interstitial Laser Thermotherapy (imILT)

Device: Immunostimulating Interstitial Laser Thermotherapy

Interventions

Immunostimulating Interstitial Laser Thermotherapy DEVICE

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.

imILT

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Clinical Laserthermia Systems AB: lead
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

Nottingham Breast Cancer Institute

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 26504041 RESULT

• 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.

  PMID: 21400025 RESULT

• 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.

  PMID: 16091763 RESULT

• 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.

  PMID: 8846867 RESULT

• 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.

  PMID: 22388047 RESULT

• 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.

  PMID: 14666667 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Hyperthermia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Kristjan S Asgeirsson, MD

  Nottingham Breast Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: February 1, 2017
• Study Start: June 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)