Phase II study of thalidomide in combination with temozolomide in metastatic malignant melanoma with brain metastases - Tem-Thal
- Conditions
- Advanced metastic malignant melanoma
- Registration Number
- EUCTR2004-005164-25-DK
- Lead Sponsor
- Odense University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
- 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
- White Blood Cell count (WBC) <3.5 x 109/l
- Neutrophils <1.5 x 109/l
- Platelets <100 x 109/l
- ALAT >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method