Melanoma Vaccine in Treating Patients With Stage III Melanoma After Surgery to Remove Lymph Nodes

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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01082198

Enrollment

Registered

2010-03-08

Start date

2002-10-31

Completion date

Unknown

Last updated

2013-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage III melanoma

Brief summary

RATIONALE: Vaccines made from dendritic cells and tumor antigen peptides or a person's tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best way to give melanoma vaccine in treating patients with stage III melanoma after surgery to remove the lymph nodes.

Detailed description

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.

Interventions

BIOLOGICALHLA-A1-binding MAGE-1/MAGE-3 multipeptide-pulsed autologous dendritic cell vaccine

BIOLOGICALHLA-A2-binding TYR/MART-1/gp100 multipeptide-pulsed autologous dendritic cell vaccine

BIOLOGICALautologous melanoma lysate-pulsed autologous dendritic cell vaccine

BIOLOGICALautologous melanoma lysate/KLH-pulsed autologous dendritic cell vaccine

BIOLOGICALdendritic cell-idiotype-keyhole limpet hemocyanin vaccine

OTHERflow cytometry

PROCEDUREadjuvant therapy

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Immune response	—
Disease-free survival	—
Overall survival	—
Adverse events	—

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026