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 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT00107159
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed primary cutaneous or unknown primary melanoma, including 1 of the following stages:
* Stage IIIB or IIIC disease
* Unresected, in-transit lymph node metastases (N2c or N3)
* Stage IV disease
* Distant skin, subcutaneous, lymph node, or pulmonary metastases (M1a or M1b)
* No cerebral, bone, or other visceral metastases
* At least 1 measurable or evaluable lesion
* Small-volume multiple cutaneous deposits allowed
* Progressive disease, as defined by 1 of the following criteria:
* At least 20% increase in size in ≥ 1 measurable or evaluable lesion
* Appearance of ≥ 1 new lesion since or during last treatment (if applicable) AND within the past 3 months
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-1
Life expectancy
* At least 6 months
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
Hepatic
* SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
* Lactic dehydrogenase normal
* No active hepatitis B or C infection
Renal
* Creatinine ≤ 1.5 times ULN
Immunologic
* No history of autoimmune disease
* Vitiligo allowed
* No history of immunodeficiency syndrome
* No active bacterial, viral, or fungal infection within the past 72 hours
* HIV-1 or -2 negative
* Human T-cell lymphotrophic virus-I or -II negative
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No contraindication to apheresis
* No other significant medical or surgical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior vaccine therapy with ≥ 1 melanoma antigen or peptide
* More than 4 weeks since prior biologic therapy
Chemotherapy
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy
* No concurrent chronic systemic corticosteroids
Radiotherapy
* More than 4 weeks since prior radiotherapy
Surgery
* Not specified
Other
* More than 4 weeks since prior investigational products
* More than 4 weeks since prior chronic systemic immunosuppressive treatment
* No concurrent medication or treatment regimen that would prelude study participation
* No other concurrent anticancer treatment
* No other concurrent immunosuppressive treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00107159
Study Brief:
Protocol Section:
NCT00107159