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 @ 3:45 PM
Ignite Modification Date:
2025-12-24 @ 3:45 PM
NCT ID:
NCT00014092
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed unresectable stage IV melanoma
* Measurable metastatic disease
* No uncontrolled brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Karnofsky 70-100%
Life expectancy:
* More than 12 weeks
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT no greater than 3 times ULN
* Alkaline phosphatase no greater than 3 times ULN
Renal:
* BUN no greater than 1.5 times ULN
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No significant cardiovascular disease
Other:
* No non-malignant systemic disease
* No acute infection requiring IV antibiotics
* No alcohol or substance abuse
* No other condition, disease, or history of other illness that would preclude study participation
* No hypersensitivity, allergic reactions, or intolerance to study drugs
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy
* No prior interleukin-2
* No other concurrent immunotherapy
* No concurrent investigational vaccines or immunomodulatory agents
* No other concurrent growth factors
Chemotherapy:
* At least 4 weeks since prior chemotherapy
* No prior temozolomide
* No other concurrent anticancer chemotherapy
Endocrine therapy:
* No concurrent steroids (including corticosteroids)
Radiotherapy:
* At least 4 weeks since prior radiotherapy
Surgery:
* See Disease Characteristics
* At least 3 weeks since prior major surgery
Other:
* At least 30 days since prior immune-based therapy
* No concurrent participation in other clinical trials with investigational drugs
* No other concurrent anticancer drugs
* No concurrent immunosuppressive therapy
* No concurrent levamisole or cimetidine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00014092
Study Brief:
Protocol Section:
NCT00014092