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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01082198
• Other study ID #: CDR0000666511
• Secondary ID: MSCMI-21/01/02EU
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 5, 2010
• Last updated: August 23, 2013
• Start date: October 2002

Study information

• Verified date: March 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• HLA-A1-binding MAGE-1/MAGE-3 multipeptide-pulsed autologous dendritic cell vaccine

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

• autologous melanoma lysate-pulsed autologous dendritic cell vaccine

• autologous melanoma lysate/KLH-pulsed autologous dendritic cell vaccine

• dendritic cell-idiotype-keyhole limpet hemocyanin vaccine

Other:
• flow cytometry

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune response			No
Primary	Disease-free survival			No
Primary	Overall survival			No
Primary	Adverse events			Yes