Topical Imiquimod or Diphenylcyclopropenone for the Management of Cutaneous In-transit Melanoma Metastases – A Phase II Single Centre Prospective Randomised Pilot Study

Phase 2

Recruiting

• Conditions: Cutaneous in-transit melanoma metastases; Cancer - Malignant melanoma

• Registration Number: ACTRN12615001088538
• Lead Sponsor: Professor B Mark Smithers

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Men or women aged 18 years or older.
2. Willing and able to comply with study requirements.
3. Capable of providing valid (written and informed) consent.
4. Histologically or cytologically proven in-transit melanoma metastases.
5. Measurable disease between 2-15mm in diameter that can be accurately assessed by ruler/calliper.
6. Between 5 to 20 in-transit melanoma lesions.
7. Lesions present in anatomical locations amenable to imiquimod or DPCP treatment.
8. Cutaneous (superficial) macular, papular or small nodular in-transit melanoma deposits.
9. Considered un-suitable for surgery by the treating surgeon due to anatomical location or prohibitive disease factors or co-morbidities, previous treatment failure or patient refusal.
10. 12 weeks minimum duration between completing comparative treatments (ILI or PV-10) to prevent potentially confounding effects (treatment responses).
11. Patients must have, in the opinion of the investigator, adequate renal, haematopoietic and hepatic function, with no clinically significant impairment or uncontrolled haematological, hepatic or renal disease.

Exclusion Criteria

1. Considered eligible for concurrent treatment with systemic chemo- or immunotherapies.
2. Subjects who have received chemotherapy or other systemic cancer therapy within 4 weeks of study.
3. Subjects who have received local treatment (e.g. surgery, cryotherapy, radiofrequency ablation) to the treatment area within four weeks of study treatment - to prevent potentially confounding effects (treatment responses/immunosuppression).
4. Life expectancy of less than 6 months or ECOG performance status equal or greater than 3.
5. Medical or psychiatric condition that compromises the patient’s ability to complete the treatment or follow-up assessments as per the protocol.
6. Unable or unwilling to provide fully informed consent and participate including patients with intellectual or mental impairment.
7. Patients who are pregnant or lactating. Women of child bearing potential must have a confirmed negative urine pregnancy test at study entry.
8. Known history of immumodeficiency including HIV, uncontrolled central nervous system metastases, concomitant systemic corticosteroid therapy, previous organ transplant.
9. Known severe concurrent or inter-current illness including: cardiovascular, respiratory or immunological) illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise their safety or compliance or interfere with interpretation of study results.
10. Previous severe adverse or allergic reaction to either treatment agent.
11. Patients unable or unwilling to comply with home application of treatment and the investigational nature of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete clinical response in treated lesions assessed using standardised measurement tools (e.g. callipers) in accordance with Response Evaluation Criteria In Solid Tumors (RECIST).[Time to complete clinical response up to a maximum of 12 months after commencing treatment.]