A Phase II study of Temozolomide (Temodal) Given Continously 100mg/m2 for 21 Days in 28 Day cycles in Patients with Metastatic Melanoma.
- Conditions
- Metastatic melanoma
- Registration Number
- EUCTR2004-002925-39-SE
- Lead Sponsor
- Kliniken för onkologi, Karolinska Universitetssjukhuset, Solna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 35
Inclusion Criteria
Histologically proven melanoma
Evidence of metastatic disease with at least one mesurable metastatic site
Performance status WHO 0-2
Age >18 years
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) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Prior chemotherapy, biologic therapy or immunotherapy for metastatic disease
Evidence of brain metases
Frequent vomiting or medical condition which could interfere with oral medication intake
Any other active malignancies or previous malignancies within the last 5 years
Pregnancy or breast feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the efficacy and safety of Temodal in a continuous dose regime in patients with metastatic melanoma and good performance status defined as WHO 0-2.;Secondary Objective: Time to progression, Overall survival, Safety, new brain metastasis, correlation of response to tumor gene and MGMT expression and SNPs, Temodal effect on Regulatory T lymphocytes.;Primary end point(s): Tumor respons rate
- Secondary Outcome Measures
Name Time Method