Ignite Creation Date:
2024-05-06 @ 12:22 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03749850
Status:
UNKNOWN
Last Update Posted:
2021-02-17
First Post:
2018-11-09
Brief Title:
Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer Phase I Feasibility Study of Hifu-Induced Hyperthermia LTLD and Cyclophosphamide for Metastatic Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
i-GO
Brief Summary:
In this phase I feasibility study the investigators evaluate the combination of lyso-thermosensitive liposomal doxorubicin LTLD ThermoDox with local hyperthermia and cyclophosphamide C for the local treatment of the primary breast tumour in patients with metastatic breast cancer
When heated to 40-43 degrees Celsius ºC LTLD releases a very high concentration of doxorubicin locally within seconds Hyperthermia of the primary tumour will be induced by Magnetic Resonance guided High Intensity Focused Ultrasound MR-HIFU on a dedicated Sonalleve MR-HIFU breast system
The investigators hypothesize that by substituting doxorubicin A in the AC-chemotherapy regimen for the combination of LTLD and MR-HIFU induced hyperthermia optimal local tumour control can be achieved without compromising systemic toxicity or efficacy
This will be the first study to evaluate LTLD with MR-HIFU hyperthermia in breast cancer patients
When heated to 40-43 degrees Celsius ºC LTLD releases a very high concentration of doxorubicin locally within seconds Hyperthermia of the primary tumour will be induced by Magnetic Resonance guided High Intensity Focused Ultrasound MR-HIFU on a dedicated Sonalleve MR-HIFU breast system
The investigators hypothesize that by substituting doxorubicin A in the AC-chemotherapy regimen for the combination of LTLD and MR-HIFU induced hyperthermia optimal local tumour control can be achieved without compromising systemic toxicity or efficacy
This will be the first study to evaluate LTLD with MR-HIFU hyperthermia in breast cancer patients
Detailed Description:
Advances in systemic treatment led to improved overall survival in patients with metastatic breast cancer Various studies suggest that by obtaining loco-regional control overall survival in advanced disease can further be improved
Pre-operative chemotherapy can be used in metastatic breast cancer to make radical removal of the primary tumor feasible while simultaneously maintaining control of already present metastatic sites The doxorubicin and cyclophosphamide regimen AC is well-known both in neo-adjuvant setting as in treatment of metastatic breast cancer At present optimal local control in advanced breast cancer using adequate dosing of doxorubicin is hampered by its toxic systemic effects Therefore the investigators aim to increase doxorubicin deposition in the primary tumor without interfering with systemic efficacy and toxicity by combining lyso-thermosensitive liposomal doxorubicin LTLD ThermoDox with local mild hyperthermia induced by Magnetic Resonance guided High Intensity Focused Ultrasound MR-HIFU When heated to 40-43 ºC ThermoDox releases a very high concentration of doxorubicin locally within seconds In the absence of hyperthermia ThermoDox leads to a similar biodistribution and antitumor efficacy to free doxorubicin MR-HIFU allows for controlled heating of deep-seated tumors
This is a single-arm phase I feasibility study in 12 patients with de novo stage IV distant metastasis at the time of diagnosis her2-negative breast cancer who have not received previous chemotherapy The study treatment consists of up to 6 cycles at 21-day intervals of ThermoDox 50mgm2 administered during MR-HIFU induced hyperthermia 60 minutes at 40-42 ᵒC and cyclophosphamide 600 mgm2 administered afterwards A dedicated MR-HIFU breast system integrated with a clinical 15 Tesla Magnetic Resonance Imaging MRI scanner will be used for safe and controlled heating of the tumour Primary endpoints are safety tolerability and feasibility Secondary endpoint is efficacy assessed by radiological response of the local tumor and the distant metastases
In the Biobank side study extra blood samples will be collected These samples will be used for further research on not yet determined topics related to breast cancer
Pre-operative chemotherapy can be used in metastatic breast cancer to make radical removal of the primary tumor feasible while simultaneously maintaining control of already present metastatic sites The doxorubicin and cyclophosphamide regimen AC is well-known both in neo-adjuvant setting as in treatment of metastatic breast cancer At present optimal local control in advanced breast cancer using adequate dosing of doxorubicin is hampered by its toxic systemic effects Therefore the investigators aim to increase doxorubicin deposition in the primary tumor without interfering with systemic efficacy and toxicity by combining lyso-thermosensitive liposomal doxorubicin LTLD ThermoDox with local mild hyperthermia induced by Magnetic Resonance guided High Intensity Focused Ultrasound MR-HIFU When heated to 40-43 ºC ThermoDox releases a very high concentration of doxorubicin locally within seconds In the absence of hyperthermia ThermoDox leads to a similar biodistribution and antitumor efficacy to free doxorubicin MR-HIFU allows for controlled heating of deep-seated tumors
This is a single-arm phase I feasibility study in 12 patients with de novo stage IV distant metastasis at the time of diagnosis her2-negative breast cancer who have not received previous chemotherapy The study treatment consists of up to 6 cycles at 21-day intervals of ThermoDox 50mgm2 administered during MR-HIFU induced hyperthermia 60 minutes at 40-42 ᵒC and cyclophosphamide 600 mgm2 administered afterwards A dedicated MR-HIFU breast system integrated with a clinical 15 Tesla Magnetic Resonance Imaging MRI scanner will be used for safe and controlled heating of the tumour Primary endpoints are safety tolerability and feasibility Secondary endpoint is efficacy assessed by radiological response of the local tumor and the distant metastases
In the Biobank side study extra blood samples will be collected These samples will be used for further research on not yet determined topics related to breast cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-005582-23 | EUDRACT_NUMBER | None | None |