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Adjuvant Vaccination With Melanoma Antigen Pulsed Dendritic Cells (DCs) in Stage III Melanoma Patients


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

Adjuvant Vaccination With Melanoma Antigen Pulsed Dendritic Cells (DCs) in Stage III Melanoma Patients


OBJECTIVES:

- Determine the feasibility of adjuvant melanoma vaccine comprising autologous dendritic
cells pulsed with tumor antigen peptides in patients with stage III melanoma following
lymphadenectomy.

- Determine the immune response (skin test of delayed-type hypersensitivity and flow
cytometric enumeration of peripheral blood CD8+ lymphocytes producing IFN-γ) to this
regimen in these patients.

- Determine clinical outcome (disease-free survival, overall survival, and adverse
events) in patients treated with this regimen.

OUTLINE: Patients undergo leukapheresis for collection of peripheral blood mononuclear cells
(PBMCs) and bone marrow mononuclear cells. Autologous dendritic cells (DCs) prepared from
PBMCs and bone marrow mononuclear cells are exposed to various antigens and peptides, and
autologous tumor cell lysate, if available. Patients receive autologous DCs pulsed with
melanoma-associated antigen peptides, and autologous DCs pulsed with tumor lysates (if
available), subcutaneously in weeks 0, 2, 5, 8, 12, 16, 20, 26, 31, 50, and 102. Patients
with no evidence of disease may receive another booster injection 5 years after the start of
vaccination.

Blood samples are examined via flow cytometry and skin testing is performed to evaluate
immune response.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of stage III melanoma

- Has undergone therapeutic lymphadenectomy

- More than 1 lymph node involvement or extracapsular extension of metastatic
melanoma cells (stage N1b-N3 disease according to AJCC 2002)

- HLA type A1 and/or A2 or A3 (if autologous tumor lysate is available)

- No presence of distant metastases

PATIENT CHARACTERISTICS:

- No other malignancy

- No evidence of lung, heart, liver, or renal failure or severe neurologic disorder

- No autoimmune disease or atopic allergy

- No HIV infection or presence of anti-HIV antibodies

- No presence of hepatitis B surface antigen or antibodies against hepatitis C virus

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Immune response

Safety Issue:

No

Principal Investigator

Sergiusz Markowicz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Authority:

Unspecified

Study ID:

CDR0000666511

NCT ID:

NCT01082198

Start Date:

October 2002

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • Melanoma

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