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

NCT01082198 | Unknown Phase 1

• 3 other identifiers: CDR0000666511MSCMI-21/01/02EU-21006
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma

Outcome Measures

Primary Outcomes (4)

• Immune response

• Disease-free survival

• Overall survival

• Adverse events

Interventions

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

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

autologous melanoma lysate-pulsed autologous dendritic cell vaccine BIOLOGICAL

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

dendritic cell-idiotype-keyhole limpet hemocyanin vaccine BIOLOGICAL

flow cytometry OTHER

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw

Warsaw, 02-781, Poland

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

Flow Cytometry; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Sergiusz Markowicz, MD

  Maria Sklodowska-Curie National Research Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 5, 2010
• First Posted: March 8, 2010
• Study Start: October 1, 2002
• Primary Completion: April 1, 2010
• Last Updated: August 26, 2013

Record last verified: 2010-03

Locations

PL (1)