Local immunotherapy by the synergism of monobenzone and imiquimod cream (MI) for cutanous metastases in stage III-IV melanoma patients. - MI trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022703-22-NL

Enrollment

Registered

2010-09-29

Start date

2011-01-03

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with cutanous melanoma (stage III-IV)

Interventions

Trade Name: Aldara Pharmaceutical Form: Cream INN or Proposed INN: IMIQUIMOD CAS Number: 99011-02-6 Concentration unit: % percent Concentration type: equal Concentration number: 5- Product Name: mono

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject is 18 years of age or older at baseline; M/F 2. Diagnosis of histopathologically confirmed melanoma 3. Presence of cutaneous metastases which are not surgically excisable 4. Performance status WHO 0 or 1 5. Subject’s most recent systemic treatment (chemotherapy, immunotherapy) was at least one month prior to inclusion 6. Subject has voluntarily signed and dated an informed consent prior to any study related procedure and is willing to comply with the requirements of this study protocol which has been approved by an Institutional Review Board (PTC) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Diagnosis of primary amelanotic melanoma 2. Symptomatic brain metastases 3. Concomitant treatment with immunosuppressive agents 4. Active systemic infections requiring antibiotics 5. For any reason, subject is considered by the local investigator to be an unsuitable candidate to participate in this trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the clinical efficacy of local treatment with monobenzone and imiquimod cream on cutaneous metastases in stage III-IV melanoma patients ;Secondary Objective: To study the induction of local tumor-specific immunity by MI treatment as measured by the accumulation of melanoma/melanocyte specific T-cells at the treatment site. In addition, potential systemic immunity will be measured in the peripheral blood. ;Primary end point(s): • To study the clinical efficacy of local treatment with monobenzone and imiquimod cream on cutaneous metastases in stage III-IV melanoma patients • To study the induction of local tumor-specific immunity by MI treatment as measured by the accumulation of melanoma/melanocyte specific T-cells at the treatment site. In addition, potential systemic immunity will be measured in the peripheral blood.	—

Measure

Time frame

Main Objective: To study the clinical efficacy of local treatment with monobenzone and imiquimod cream on cutaneous metastases in stage III-IV melanoma patients ;Secondary Objective: To study the induction of local tumor-specific immunity by MI treatment as measured by the accumulation of melanoma/melanocyte specific T-cells at the treatment site. In addition, potential systemic immunity will be measured in the peripheral blood. ;Primary end point(s): • To study the clinical efficacy of local treatment with monobenzone and imiquimod cream on cutaneous metastases in stage III-IV melanoma patients • To study the induction of local tumor-specific immunity by MI treatment as measured by the accumulation of melanoma/melanocyte specific T-cells at the treatment site. In addition, potential systemic immunity will be measured in the peripheral blood.

—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026