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:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00301067
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed malignant melanoma
* Any primary tumor site
* Stage IV disease
* CNS metastases allowed
* Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Must have had at least 1 prior systemic therapy
* Negative pregnancy test
* Fertile patients must use effective contraception
* Patients with no prior systemic therapy are eligible provided they are not candidates for high-dose interleukin-2
* Recovered from all toxic effects of prior therapy
* More than 4 weeks since prior and no concurrent radiotherapy, chemotherapy, or immunotherapy
* More than 4 weeks since prior and no concurrent radiotherapy, chemotherapy, or immunotherapy
* Fertile patients must use effective contraception
Exclusion Criteria:
* Life expectancy less than 4 months
* known HIV positivity
* evidence of active infection requiring antibiotic therapy
* other malignancy within the past 5 years except surgically resected basal cell or squamous cell skin cancer
* significant medical disease which, in the opinion of the investigator, may interfere with study completion
* pregnant or nursing
* Negative pregnancy test
* prior temozolomide or dacarbazine
* investigational agent within 4 weeks prior to study entry
* concurrent magnesium-containing antacids, digitalis, bile-resin binding drugs, or calcium supplements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00301067
Study Brief:
Protocol Section:
NCT00301067