Status:
COMPLETED
Monocentric Pilot Study Investigating the Metabolic Activity of Melanoma in Vivo During Sorafenib and Dacarbazine
Lead Sponsor:
University of Zurich
Conditions:
Melanoma Stage III or IV
No Prior Chemotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Investigation of the metabolic activity of sorafenib and sorafenib plus dacarbazine on melanoma metastasis in patients with melanoma stage III or IV on the basis of PET/CT, LDH and S-100 evaluation. A...
Detailed Description
A total of 12 patients with skin- or superficial lymph node metastases with a diameter of at least 1 cm will be chosen for sorafenib therapy over 56 days per os twice daily with each 400 mg and, addit...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age \> 18 years.
- Histologically or cytologically confirmed unresectable (stage III) or metastatic (stage IV) melanoma for whom treatment with dacarbazine is considered medically acceptable.
- No prior chemotherapy.
- ECOG Performance Status of 0 or 1.
- Life expectancy of at least 12 weeks.
- Subjects with at least one uni-dimensional (for RECIST) or bi-dimensional (for WHO) measurable lesion. Lesions must be measured by CT-scan or MRI.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: Hemoglobin \>= 9.0 g/dl. Absolute neutrophil count (ANC) \>=1,500/mm3. Platelet count \>=100,000/ìl. Total bilirubin \<= 1.5 times the upper limit of normal. ALT and AST \<= 2.5 x upper limit of normal (\< 5 x upper limit of normal for patients with liver involvement of their cancer). Alkaline phosphatase \< 4 x ULN. PT-INR/PTT \< 1.5 x upper limit of normal \[Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists\]. Serum creatinine \<= 1.5 x upper limit of normal.
- Signed and dated informed consent before the start of specific protocol procedures.
- Baseline serum LDH level \> 1.1 ULN.
- Assessable metastases (Skin or superficial lymph nodes, minimal diameter 1 cm)
- EXCLUSION CRITERIA:
- History of cardiac disease: congestive heart failure \> NYHA class
- active CAD (MI more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension.
- History of HIV infection or chronic hepatitis B or C.
- Active clinically serious infections (\> grade 2 NCI-CTC version 3.0).
- Symptomatic metastatic brain or meningeal tumors (unless the patient is \> 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry).
- Patients with seizure disorder requiring medication (such as steroids or anti-epileptics).
- History of organ allograft.
- Patients with evidence or history of bleeding diathesis.
- Patients undergoing renal dialysis.
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors \[Ta, Tis \& T1\] or any cancer curatively treated \> 3 years prior to study entry.
- Primary ocular melanoma
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00794235
Start Date
December 1 2008
End Date
January 1 2010
Last Update
January 8 2010
Active Locations (1)
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1
Department of Dermatology, University Hospital Zurich
Zurich, Canton of Zurich, Switzerland, 8091