CompletedPhase 2ACTRN12609000475246

Topical immunotherapy with diphencyprone for cutaneous metastatic melanoma

Response of cutaneous metastatic melanoma to topical immunotherapy with diphencyprone

Sponsor

Royal Prince Alfred Hospital

Enrollment

50 participants

Start Date

Jun 16, 2009

Study Type

Interventional

Conditions

Melanoma metastatic and/or locally recurrent to skin

Summary

The objective is to investigate whether diphencyprone (DPCP), a chemical which can cause contact allergy on the skin in about 95% of people, can stimulate the immune system to destroy these melanoma cells. DPCP is frequently used in dermatology as a treatment for autoimmune hair loss (alopecia areata) and warts, where it also stimulates an immune attack on the wart virus. As melanoma is a tumour which is known to be particularly susceptible to immune attack, it is hoped that DPCP treatment will be helpful to patients with otherwise untreatable secondary melanoma in their skin. There have so far been a handful of published case reports of patients in whom DPCP has been helpful for melanoma.

Eligibility

Sex: Both males and females

Inclusion Criteria1

Melanoma locally recurrent or metastatic to skin

Exclusion Criteria4

Pregnancy or lactation
Severe uncontrolled eczema
Previous type I hypersensitivity to diphencyprone
Primary melanoma

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Interventions

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 de

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.

Locations(1)

NSW, Australia

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ACTRN12609000475246