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 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT00453050
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed melanoma meeting the following criteria:
* Stage III or IV disease
* Stage IV disease without observable, surgically unresectable metastases beyond the immediate treatment site allowed
* Presence of 1 or more cutaneous metastases ≤ 3 cm in size
* Diffuse areas of tumor involvement can be used to qualify for the study if these areas involve primarily the epidermis and/or dermis and are less than 3 cm in thickness
* No uncontrolled brain metastases
* Treated brain metastases that are stable for 3 months allowed at the investigator's discretion
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Life expectancy ≥ 4 months
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 month after study completion
* No known allergy to any drugs used during study treatment
* No unstable medical illness
* Not immunosuppressed
* Patients immunosuppressed due to disease (e.g., HIV positive) allowed
PRIOR CONCURRENT THERAPY:
* No systemic steroids or any other immunosuppressive medications within the past month
* No chemotherapy within the past 4 weeks
* No radiotherapy to the treatment site within the past 4 weeks
* Palliative radiotherapy to sites other than cutaneous treatment and assessment sites allowed
* No concurrent immunosuppressive agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00453050
Study Brief:
Protocol Section:
NCT00453050