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 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT01124734
Eligibility Criteria:
Inclusion Criteria:
* Pathologically confirmed metastatic malignant melanoma
* Age \> 18 years
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Patients considered good candidate for conventional high dose IL-2
* No chemotherapy, hormonal therapy, immunotherapy or radiation therapy within 1 month of entry
* Patients with a history or clinical evidence of brain metastasis must have completed radiation therapy or surgical treatment of brain lesions and have no evidence of central nervous system progression for at least 8 weeks at the time of enrollment.
* Patients may have had prior high dose IL-2 or temozolomide but not together or with high dose IL-2 followed by temozolomide
* Patients may have had prior high dose interferon as adjuvant treatment for high risk melanoma
* Serum creatinine \< 2 mg/dL
* Bilirubin \< 2 mg/dL
Exclusion Criteria:
* Inability to provide informed consent
* Hypersensitivity to temozolomide or HD IL-2
* Active gastrointestinal disorder or cardiac disorders
* Ejection fraction \< 50% by echocardiogram or corrected diffusing capacity of lung for carbon monoxide \< 50% on diffusion capacity testing pulmonary function tests
* platelets \< 100 K, neutrophils \< 1000
* Serum Creatinine \< 2 x the upper limits of normal
* Chronic use of steroids other than for simple adrenal replacement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01124734
Study Brief:
Protocol Section:
NCT01124734