Phase II study of first-line therapy with Thalidomide in combination with Peg-introna and decrescendo IL-2 in patients with metastatic malignant melanoma - Decrescendo

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-005166-20-DK

Enrollment

Registered

2005-04-01

Start date

2005-04-14

Completion date

Unknown

Last updated

2016-10-03

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

Conditions

Metastatic malignant melanoma

Interventions

Product Name: Thalidomide Pharmion Pharmaceutical Form: Capsule, hard Trade Name: Peg Intron Product Name: Peginterferon alpha 2b Product Code: 20274 Pharmaceutical Form: Powder for solution for inje

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Biopsy verified metastatic malignant melanoma in progression - At least one measurable lesion using the RECIST criteria - Age =18 and = 70 years - Performance status WHO 0-2 - Adequate bone marrow, renal and hepatic function - Written and oral informed consent according to the Ethical Committees 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: - Prior treatment with IL-2 - Pregnant or breastfeeding women - Male or female patients with reproductive potential must use an approved contraceptive method during and for 3 months after the end of study treatment evaluation - Patients with a history of other malignancies, except if there is a disease-free interval of at least 5 years or patients with a prior history of adequately treated basal cell carcinoma of the skin or carcinoma in-situ of the cervix - Clinical significant infection - Symptomatic cardiac disease - Brain metastases - Any medical condition that might be aggravated by treatment or which could not be controlled: i.e. active infection - Organ transplantation or autoimmune disease - Systematic treatment with adrenocortical hormone - Epilepsy, other central nervous disease or significant psycological conditions which do not permit medical follow-up and compliance with the study

Design outcomes

Primary

Measure	Time frame
Main Objective: Determination of efficacy and toxicity of a new combination of drugs;Secondary Objective: ;Primary end point(s): To investigate the efficacy of oral Thalidomide in combination with IL-2 and PEG-Introna in patients with metastatic malignant malanoma	—

Countries

Denmark

Outcome results

None listed

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