Advanced metastic malignant melanoma
Conditions
Interventions
Trade Name: Temodal
Product Name: Temozolomide
Product Code: 20043
Pharmaceutical Form: Capsule*
Product Name: Thalidomide Pharmion
Pharmaceutical Form: Capsule, hard
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Biopsy verified malignant melanoma - Performance status =2 - Expected lifetime of =3 months - Age =18 years - Written and oral informed consent according to the Ethical Committees - Participation in Pharmions Risk Management Program - Progressive brain metastases (not requireing treatment with steroids) 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: - White Blood Cell count (WBC) 2.5 x Upper Normal Limit (UNL) - ALP >2.5 x UNL - Bilirubin >1.5 x UNL - Creatinine >1.5 x UNL - Pregnant or breast feeding women - Women of childbearing potential must use safe anticontraception and men must ensure that they use condom - Prior treatment with IL-2 or progression after/during treatment with IL-2 - Patients having received any other experimental or anti-cancer therapy within 4 weeks before study drug administration - Any medical condition that might be aggravated by treatment or which could not be controlled
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine tumor response rate including determination of stabel disease;Secondary Objective: Time to progression, overall survival and tolerability of the regimen according to Common Toxicity Criteria;Primary end point(s): To determine the efficacy oral Thalidomide and Temozolomide in combination in patients with metastatic malignant melanoma spreading to the brain | — |
Countries
Denmark
Outcome results
None listed