Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT00548561
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2007-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of TopotectTM (Dexrazoxane) for Accidental Extravasation of Anthracyclines
Sponsor:
Valerio Therapeutics
Organization:
Study Overview
Official Title:
A Clinical Trial on TopotectTM (Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
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:
None
Brief Summary:
The purpose of this study is to avoid surgical intervention following extravasation of anthracycline chemotherapy out of a vessel into the surrounding tissues.
Detailed Description:
Accidental extravasation of anthracyclines including doxorubicin and its derivative epirubicin, may cause severe, progressive tissue necrosis requiring the surgical removal of any damaged tissue. Thus, the patient is subjected to major surgery causing substantial delay of the treatment of the primary cancer disease.
Tissue infiltration by anthracyclines may be detected by fluorescence microscopy. This test is performed at most hospitals in Denmark.
In a large preclinical trial, as well as 4 clinical cases, dexrazoxane has proven to prevent these severe tissue necroses. This trial will determine the effect of dexrazoxane as an acute treatment (acute antidote) in patients with anthracycline extravasation verified by fluorescence biopsy.
Purpose
Primary:
• To avoid surgical intervention following the accidental extravasation of anthracycline drug, and thus preventing the patient from sequelae.
Secondary:
* To avoid deleterious postponement of the cancer treatment itself.
* To evaluate and describe subjective and objective symptoms in the damaged area following treatment with TopotectTM.
* To evaluate tolerability/toxicity of TopotectTM used for this indication, according to the indicated schedule.
Trial Population 25 patients with accidental anthracycline extravasation confirmed by fluorescence microscopy
Trial Design Open-label clinical trial. Twenty-five consecutive patients with an acute (\<6 hours) history of anthracycline extravasation confirmed by fluorescence microscopy (who in general practice are candidates for acute plastic surgical intervention) will be included.
Effect Variables Response rates, presence of late sequelae, time to progression, and clinical consequence of progression.
Safety Features
* Any toxicity caused by TopotectTM will be studied by blood tests, systematic questioning regarding subjective discomfort, as well as by objective clinical examination.
* A systematic clinical evaluation of the marked area of skin covering the area of extravasation will be performed to assure prompt treatment should any deterioration occur.
* Sequential colour photographs of the involved skin area will be taken.
Tissue infiltration by anthracyclines may be detected by fluorescence microscopy. This test is performed at most hospitals in Denmark.
In a large preclinical trial, as well as 4 clinical cases, dexrazoxane has proven to prevent these severe tissue necroses. This trial will determine the effect of dexrazoxane as an acute treatment (acute antidote) in patients with anthracycline extravasation verified by fluorescence biopsy.
Purpose
Primary:
• To avoid surgical intervention following the accidental extravasation of anthracycline drug, and thus preventing the patient from sequelae.
Secondary:
* To avoid deleterious postponement of the cancer treatment itself.
* To evaluate and describe subjective and objective symptoms in the damaged area following treatment with TopotectTM.
* To evaluate tolerability/toxicity of TopotectTM used for this indication, according to the indicated schedule.
Trial Population 25 patients with accidental anthracycline extravasation confirmed by fluorescence microscopy
Trial Design Open-label clinical trial. Twenty-five consecutive patients with an acute (\<6 hours) history of anthracycline extravasation confirmed by fluorescence microscopy (who in general practice are candidates for acute plastic surgical intervention) will be included.
Effect Variables Response rates, presence of late sequelae, time to progression, and clinical consequence of progression.
Safety Features
* Any toxicity caused by TopotectTM will be studied by blood tests, systematic questioning regarding subjective discomfort, as well as by objective clinical examination.
* A systematic clinical evaluation of the marked area of skin covering the area of extravasation will be performed to assure prompt treatment should any deterioration occur.
* Sequential colour photographs of the involved skin area will be taken.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: