TEAM (Treat, Excise, Analyse for Melanoma)

Location: Melanoma Institute Australia North Sydney/Westmead/ RPAH
Trial status: Open
Treatment type: Biomarker
Stage: IIIb/IIIc/IV
Intent of treatment:

Title: Biomarker evaluation of short-term administration of chemotherapeutic, immunological or biologic agents in patients with unresectable stage IIIb, IIIc or IV melanoma amenable to pre and post treatment biopsy. 

Target population: Male and female patients ≥ 18 years of age with a histologic or cytologic diagnosis of unresectable Stage IIIb, IIIc or IV malignant melanoma, who are willing to submit to at least 2 on-study biopsies pre- and post cycle 1 of systemic drug therapy (chemotherapeutic, immunological or biological agents as per institutional guidelines) and meet the inclusion and exclusion criteria.

The purpose of this study is to investigate what changes in the chemistry of melanoma cells occur after a single dose of a chemotherapeutic or biological agent used in melanoma treatment.

Pre-clinical studies indicate that some combination of these drugs may have activity in certain patients with metastatic melanoma although there is no evidence yet that any combination of these drugs prolongs life.

Doctors hope to use information from serial biopsies to guide the selection of drugs in future large clinical trials by analyzing the pattern changes that occurs in these specimens.

Once consented, the patient’s surgeon will also remove one clinically benign normal mole before and after the melanoma drug treatment. This will assist the research team to determine what effects the drugs are having on the “computer program” of the cells that sometimes go on to form melanoma.

Anti-melanoma therapy will be selected by the treating clinician according to existing standards protocols. A single course of this anti-melanoma treatment will be administered.

All potentially eligible patients will be from the patient population of Melanoma Institute Australia. These patients will be currently managed by the clinicians of the Institute.

Contacts
Principal Investigator: Professor John Thompson
Trial Coordinator: Maria Synnott: +61 2 9911 7306
Trial coordinator: Maria Gonzalez: +61 2 9911 7300

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