EUCTR2006-002168-24-ITActive, not recruitingNot Applicable
O6-alkylguanine-DNA-alkyltransferase modulation study Fotemustine plus Temozolomide phase I/II . - ND
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Cutaneous mucosal and ocular metastatic melanoma stage III, IV not eligible to surgical treatment; 2. accessible metastases; 3. measurable disease, confirmed by X-Ray, ultrasonography, CT or MRI scans or by clinical measurement in case of superficial lesions; 4. age 18 and 80; 5. ECOG performance status 2; 6. no previous chemotherapy for stage III and IV; 7. at least 4 weeks following previous anticancer medical therapy; 8. no prior radiotherapy within the last 4 weeks before enrollment on the target lesions; 9. if female, not pregnant or lactating. Documentation of a negative serum HCG pregnancy test for women is required prior to enrolment. Women of childbearing potential must use a contraceptive method; 10. adeguate bone marrow function neutrophils 1500/ 956;L; platelets 100,000/ 956;L; haemoglobin 10 g/dL; 11. normal renal and liver function serum creatinine 1.25 X the institution s upper limit of normal ULN ; BUN 25 mg/dL; serum bilirubin 1.25 X ULN; SGOT/AST and SGPT/ALT 1.5 X ULN; alkaline phosphatase 2 X ULN; 12. life expectancy 6 months; 13. signed written informed consent approved by the local Ethics Committee obtained enter in the study.
- •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
- •1. No complete recovery from any toxicity due to previous treatments; 2. any other previous in the last 5 years or concurrent cancer, other than resected not melanoma skin cancer or carcinoma in situ of the uterine cervix; 3. patients with symptomatic cerebral or leptomeningeal involvement; 4. any chronic debilitant disease that could interfere with the study treatment and the follow-up; 5. any concomitant treatment with other investigational agents; 6. any uncontrolled intercurrent serious acute or chronic illness ies , bleeding disorders, clinically significant heart disease CTC grade III IV ; 7. any psychological, familiar, sociological or geographical state that could potentially interfere with the study protocol compliance.
Investigators
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