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 @ 4:15 PM
Ignite Modification Date:
2025-12-24 @ 4:15 PM
NCT ID:
NCT00068666
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage IV malignant melanoma with measurable and unresectable disease limited to the central nervous system (CNS)
* Study entry within 14 days of diagnosis of brain metastases
* Recursive partitioning analysis class I or II
* Disease for which no known standard therapy exists that is potentially curative or proven capable of extending life expectancy
* No meningeal carcinomatosis based on imaging studies or on positive results from CSF analysis
* No evidence of metastatic disease outside of the CNS
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 70-100%
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL
Hepatic
* AST no greater than 3 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 3 times ULN
Renal
* Creatinine no greater than 1.5 times ULN
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent uncontrolled infection
* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer treated with local resection only
* No prior allergy or intolerance to dacarbazine
* No hypersensitivity to temozolomide or any of its components
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior biologic therapy
* More than 4 weeks since prior immunotherapy
Chemotherapy
* No prior temozolomide
* More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
Endocrine therapy
* Concurrent steroids allowed if dose stable for at least 7 days prior to CNS imaging
Radiotherapy
* More than 4 weeks since prior radiotherapy
* No prior radiotherapy to more than 15% of the bone marrow
* No prior radiotherapy to the head and neck area
* No prior radiosurgery
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00068666
Study Brief:
Protocol Section:
NCT00068666