Know Cancer

forgot password

Immune Responses To Antigen-Bearing Dendritic Cells in Patients With Malignancy - A Phase I Trial in Melanoma

Phase 1
18 Years
Not Enrolling

Thank you

Trial Information

Immune Responses To Antigen-Bearing Dendritic Cells in Patients With Malignancy - A Phase I Trial in Melanoma

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate safety and toxicity of immunizations of patients with stage III/IV melanoma, using autologous DCs pulsed with antigenic peptides expressed by melanoma, together with class I MHC (influenza) and class II MHC (KLH) -restricted control antigens.

Outcome Time Frame:

conclusion of the study

Safety Issue:


Principal Investigator

James Young, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

April 2011

Related Keywords:

  • Melanoma
  • 98-098
  • Melanoma



Memorial Sloan Kettering Cancer Center New York, New York  10021