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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00700167
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of metastatic melanoma, AJCC stage III or IV, with histologic confirmation by Dept. of Pathology at MSKCC.
* Patients must be HLA-A\*0201 positive.
* Expected survival of greater than 3 months.
* Karnofsky performance status 70 or better.
* Patients may not have received chemotherapy, immunotherapy, or radiation within approximately 4 weeks (approximately 6 weeks for nitrosoureas or mitomycin) before participation in this protocol.
* Patients should not be receiving immune modifying pharmacologics (e.g., interferon) for approximately 2-4 weeks before enrollment.
Exclusion Criteria:
* Pregnant (clinically documented or positive pregnancy test within approximately 2 wks of study entry) or lactating women, because immunization will include differentiation antigens shared by melanoma tumors and melanocytes, and immune responses to these differentiation antigens could have unknown developmental sequelae to a fetus or infant.
Pregnancy tests are not required for post-menopausal women, and post-menopausal status by patient report should be documented accordingly.
* Patients requiring systemic corticosteroids or comparable exogenous immunosuppressive agent(s) (no exclusion for use of NSAIDs)
* Patients who have a known immunodeficiency (e.g., infection with HTLV-1,2, HIV-1,2; etc.) because of the T cell defects that would alter their responses and the investigators' ability to assess their outcomes accurately.
* Patients with preexisting retinal or choroidal eye disease.
* Patients with coexisting autoimmune diseases, except vitiligo.
* Patients with significantly impaired hematologic, hepatic, or renal function, e.g., ANC \<1000, hgb \< 8.0 g/dl, plts \< 50,000/ul, AST \>3x ULN, creatinine \>2.0 or Cl creat \<30ml/min, all assessed within approximately two weeks of study entry.
* Patients with serious coexisting medical illness.
* Patients with organ allografts.
* Patients who are s/p splenectomy or s/p splenic irradiation.
* Patients with active brain metastases.
* Patients with organic brain syndrome or psychologic impairment that would preclude participation and compliance with this protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00700167
Study Brief:
Protocol Section:
NCT00700167