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

Phase 1

• Conditions: Metastatic malignant melanoma

• Registration Number: EUCTR2004-005166-20-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04-01
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified