Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

NCT00053391 | Completed Phase 1

• 3 other identifiers: CDR0000258491ERLANGEN-1490EU-20232
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage III or stage IV melanoma.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Outcome Measures

Primary Outcomes (3)

• Comparison of the efficacy of vaccination with vs without ex vivo CD40-ligand in terms of tumor-specific T-cell response

• Safety

• Tolerability

Secondary Outcomes (2)

• Tumor response

• Recurrence rates

Interventions

recombinant CD40-ligand BIOLOGICAL

therapeutic autologous dendritic cells BIOLOGICAL

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed stage III or IV cutaneous malignant melanoma * HLA-A1 and/or HLA-A2 expression by serologic HLA typing * HLA-A2.1 subtype must be confirmed by polymerase chain reaction on genomic DNA obtained from peripheral blood mononuclear cells * No active CNS metastases by CT scan or MRI PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Karnofsky 60-100% Life expectancy * At least 4 months Hematopoietic * WBC greater than 2,500/mm\^3 * Neutrophil count greater than 1,000/mm\^3 * Lymphocyte count greater than 700/mm\^3 * Platelet count greater than 75,000/mm\^3 * Hemoglobin greater than 9 g/dL * No bleeding disorders Hepatic * Bilirubin less than 2.0 mg/dL * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine less than 2.5 mg/dL Cardiovascular * No clinically significant heart disease Pulmonary * No clinically significant respiratory disease Immunologic * No active systemic infection * No immunodeficiency disease * No evidence of HIV-1, HIV-2, or human T-cell lymphotropic virus-1 * No active autoimmune disease including (but not limited to): * Lupus erythematosus * Autoimmune thyroiditis or uveitis * Multiple sclerosis * Inflammatory bowel disease Other * Stable medical condition * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 1 month after study participation * No organic brain syndrome or psychiatric illness that would preclude study compliance * No other concurrent active malignancy * No other concurrent serious illness that would preclude study treatment * No contraindication to leukapheresis PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior immunotherapy * No other concurrent immunotherapy Chemotherapy * More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas) * No concurrent chemotherapy Endocrine therapy * No concurrent corticosteroids Radiotherapy * More than 4 weeks since prior radiotherapy * No prior radiotherapy to the spleen * Concurrent palliative radiotherapy allowed Surgery * Recovered from prior surgery * No prior splenectomy * No prior organ allograft * Concurrent surgery on selected metastases (e.g., because of pain or local complications such as compression) allowed Other * No other concurrent investigational drugs * No concurrent participation in another clinical trial

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

Sponsors & Collaborators

• University Hospital Erlangen: lead

Study Sites (1)

Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen

Erlangen, D-91052, Germany

Location

Related Publications (1)

• Gross S, Erdmann M, Haendle I, Voland S, Berger T, Schultz E, Strasser E, Dankerl P, Janka R, Schliep S, Heinzerling L, Sotlar K, Coulie P, Schuler G, Schuler-Thurner B. Twelve-year survival and immune correlates in dendritic cell-vaccinated melanoma patients. JCI Insight. 2017 Apr 20;2(8):e91438. doi: 10.1172/jci.insight.91438. eCollection 2017 Apr 20.

  PMID: 28422751 DERIVED

MeSH Terms

Conditions

Melanoma

Interventions

CD40 Ligand

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)

Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Tumor Necrosis Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Membrane Proteins; Biological Factors

Study Officials

• Gerold Schuler

  Dermatologische Klinik MIT Poliklinik-Universitaetsklinikum Erlangen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator Prof. Dr. Schuler Gerold

Study Record Dates

• First Submitted: January 27, 2003
• First Posted: January 28, 2003
• Study Start: October 1, 2002
• Primary Completion: June 1, 2005
• Study Completion: June 1, 2007
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

DE (1)