Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT00811759
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of unresectable or metastatic melanoma
* Stage III or IV disease
* Previously treated or untreated metastatic disease
* At least one unidimensionally measurable lesion by RECIST criteria by scan or MRI
* No concurrent brain or CNS metastases
PATIENT CHARACTERISTICS:
* WHO performance status 0-1
* Life expectancy ≥ 3 months
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin \> 9 g/dL
* PT, INR, and PTT \< 1.5 times upper limit of normal (ULN)
* Transaminases \< 2.5 times ULN (\< 5 in the case of liver metastases)
* Amylase and lipase \< 1.5 times ULN
* Bilirubin ≤ 1.5 times ULN
* Serum creatinine \< 1.5 times ULN
* Normal respiratory, cardiac, and neurological function
* Not pregnant or nursing
* No history of any of the following cardiac conditions:
* NYHA class II-IV heart failure
* Coronary disease
* Myocardial infarction within the past 6 months
* Cardiac arrhythmia requiring treatment with something other than beta-blockers or digoxin
* Severe uncontrolled hypertension
* No severe active infection \> grade 2
* No epilepsy requiring medical treatment
* No other cancer except for carcinoma in situ of the cervix, basal cell carcinoma, superficial bladder tumors, or curatively treated cancer \> 3 years ago
* No HIV or hepatitis B or C positivity
* No lactase or galactokinase deficiency, galactose intolerance, or disease accompanied by malabsorption of glucose or galactose
* No allergy to the study drugs or to dacarbazine
* Able to swallow medications
* No patients deprived of liberty
* No psychological, familial, social, or geographic conditions that would preclude clinical follow up
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior organ transplantation
* No prior temozolomide or sorafenib tosylate
* More than 30 days since other prior antitumor chemotherapy, immunotherapy, hormonal therapy, or investigational agent
* More than 30 days since prior study drugs
* More than 3 weeks since prior radiotherapy
* More than 3 weeks since prior biological response modifiers (i.e., filgrastim \[G-CSF\])
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00811759
Study Brief:
Protocol Section:
NCT00811759