Status:
COMPLETED
Immune Responses To Antigen-Bearing Dendritic Cells in Patients With Malignancy
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Cancer cells make proteins called antigens that act as markers for the tumor cells. These antigens cannot cause the cancer itself. Special white blood cells, called T cells or T lymphocytes, recognize...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00700167
Start Date
September 1 2001
End Date
April 1 2011
Last Update
April 20 2011
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065