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 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT00056134
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed locoregional or metastatic cutaneous malignant melanoma
* Stage III or IV disease
* Stage III: pT4b, N0, M0 (satellite metastases) or any pT, N1 or pT, N1 or N2a-c, M0 (lymph node metastases or in transit intralymphatic metastases)
* Stage IV: any pT, N1-2, M1a-b
* Surgically incurable
* Incurable with standard treatment (i.e., localized chemotherapy/limb perfusion for stage III, systemic chemotherapy for stage IV)
* Unidimensionally or bidimensionally measurable disease by physical examination (e.g., cutaneous metastases) and/or non-invasive radiologic procedures NOTE: Stage III lesions may be measurable lymph nodes after incomplete resection and/or inoperable in transit metastases
* HLA-A1 and/or HLA-A2 expression by serologic HLA typing
* HLA-A2.01 subtype must be confirmed by polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells
* No active CNS metastases
* Previously treated CNS metastases (e.g., excision of a single metastasis) allowed if no active disease present by CT scan or MRI
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* Karnofsky 60-100%
Life expectancy
* At least 6 months
Hematopoietic
* WBC greater than 2,500/mm\^3
* Neutrophil count greater than 1,000/mm\^3
* Lymphocyte count greater than 700/mm\^3
* Platelet count greater than 75,000/mm\^3
* Hemoglobin greater than 9 g/dL
* No bleeding disorders
Hepatic
* Bilirubin less than 2.0 mg/dL
* No hepatitis B or C
Renal
* Creatinine less than 2.5 mg/dL
Cardiovascular
* No clinically significant heart disease
Pulmonary
* No clinically significant respiratory disease
Immunologic
* No active systemic infection
* No immunodeficiency disease
* No evidence of HIV-1, HIV-2, or human T-cell lymphocytic virus-1
* No active autoimmune disease including, but not limited to:
* Lupus erythematosus
* Autoimmune thyroiditis or uveitis
* Multiple sclerosis
* Inflammatory bowel disease NOTE: Vitiligo allowed
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No organic brain syndrome or significant psychiatric abnormality that would preclude study participation and follow-up
* No contraindication to leukapheresis
* No other active malignant neoplasms
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior systemic immunotherapy
* No concurrent immunotherapy during and for 2 weeks after last vaccination
Chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas \[e.g., fotemustine\])
* No concurrent chemotherapy during and for 2 weeks after last vaccination
Endocrine therapy
* No concurrent corticosteroids during and for 2 weeks after last vaccination
Radiotherapy
* No prior radiotherapy to the spleen
* Concurrent palliative radiotherapy allowed for selected metastases (e.g., pain or local complications such as compression)
Surgery
* See Disease Characteristics
* Recovered from prior surgery
* No prior splenectomy
* No prior organ allografts
* Concurrent surgery of selected metastases (e.g., pain or local complications such as compression) allowed
Other
* No other concurrent investigational drugs during and for 2 weeks after last vaccination
* No concurrent paramedical substance during and for 2 weeks after last vaccination
* No concurrent participation or intent to participate in another clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT00056134
Study Brief:
Protocol Section:
NCT00056134