Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000475246
Ethics application status
Approved
Date submitted
5/06/2009
Date registered
17/06/2009
Date last updated
29/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Topical immunotherapy with diphencyprone for cutaneous metastatic melanoma
Scientific title
Response of cutaneous metastatic melanoma to topical immunotherapy with diphencyprone
Secondary ID [1] 283663 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma metastatic and/or locally recurrent to skin 236933 0
Condition category
Condition code
Cancer 237292 237292 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Topical application of diphencyprone cream to cutaneous metastases.

The optimal diphencyprone dose is determined in each patient as the concentration causing adequate but not excessive contact dermatitis. The concentration may range from 0.0001% to 2%, mixed in aqueous cream. The cream is applied once per week, for 24 to 48 hours depending on intensity of response.

If there has been no response in 3 months, the treatment will be ceased. If there is response, the treatment can be continued indefinitely until refractory disease recurrence/progression. Usually, patients will require ~1 to 3 months to achieve a response. Ongoing treatment (ie, cream applied each week at home by patients) will then be offered to any patients who request it, with the aim of preventing further recurrence.
Intervention code [1] 236723 0
Treatment: Drugs
Intervention code [2] 236757 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238103 0
Clinical clearance of cutaneous metastases (ie, active cutaneous lesions are no longer visible or palpable)
Timepoint [1] 238103 0
1, 3, 6, 12 and 24 months following development of contact hypersensitivity response to diphencyprone
Secondary outcome [1] 242311 0
Histological clearance of cutaneous metastases (S100 stain after melanin bleaching on biopsy taken from treated area)
Timepoint [1] 242311 0
1, 3, 6, 12 and 24 months following development of contact hypersensitivity response to diphencyprone

Eligibility
Key inclusion criteria
Melanoma locally recurrent or metastatic to skin
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or lactation
Severe uncontrolled eczema
Previous type I hypersensitivity to diphencyprone
Primary melanoma

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No treatment allocation: uncontrolled study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2009
Actual
16/06/2009
Date of last participant enrolment
Anticipated
Actual
4/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 237119 0
Hospital
Name [1] 237119 0
Royal Prince Alfred Hospital
Country [1] 237119 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 4612 0
None
Name [1] 4612 0
Address [1] 4612 0
Country [1] 4612 0
Other collaborator category [1] 705 0
Other Collaborative groups
Name [1] 705 0
Sydney Melanoma Unit
Address [1] 705 0
GH3, Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country [1] 705 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239216 0
Sydney South West Area Health Service Ethics Committee
Ethics committee address [1] 239216 0
Ethics committee country [1] 239216 0
Australia
Date submitted for ethics approval [1] 239216 0
Approval date [1] 239216 0
09/04/2009
Ethics approval number [1] 239216 0
09/RPAH/50

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29712 0
Prof Diona Damian
Address 29712 0
Dermatology, GH3
Royal Prince Alfred Hospital
Camperdown NSW 2050
Country 29712 0
Australia
Phone 29712 0
+612 9515 8295
Fax 29712 0
Email 29712 0
[email protected]
Contact person for public queries
Name 12959 0
Diona Damian
Address 12959 0
Dermatology, GH3
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 12959 0
Australia
Phone 12959 0
612 9515 8295
Fax 12959 0
612 9565 1048
Email 12959 0
[email protected]
Contact person for scientific queries
Name 3887 0
Diona Damian
Address 3887 0
Dermatology, GH3
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 3887 0
Australia
Phone 3887 0
612 9515 8295
Fax 3887 0
612 9565 1048
Email 3887 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.