Vaccine Therapy in Treating Patients With Metastatic Melanoma Who Are Undergoing Surgery for Lymph Node and Tumor Removal

2014-08-27 03:58:47 | BioPortfolio


RATIONALE: Vaccines made from a person's white blood cells and melanoma cells may make the body build an immune response and kill the tumor cells.

PURPOSE: Randomized phase I/II trial to study the effectiveness of vaccine therapy made from white blood cells and melanoma cells in treating patients with metastatic melanoma who are undergoing surgery for lymph node and tumor removal.


OBJECTIVES: I. Determine the safety and toxicity of intravenous injections of autologous cultured dendritic cells pulsed with either gp100 and tyrosinase peptides or autologous melanoma tumor cell lysates in patients with metastatic melanoma. II. Determine whether treatment with melanoma tumor antigen pulsed autologous dendritic cells results in increased in vitro tumor specific cytotoxic T-cell responses. III. Determine whether this treatment can induce positive skin test responses to tumor antigens. IV. Evaluate the disease free and overall survival of these patients.

OUTLINE: This is a randomized, dose escalation study. Approximately 1-2 weeks following surgical lymphadenectomy, patients undergo leukapheresis to collect dendritic cells and are then divided into 3 groups. Group A consists of patients without adequate tumor for preparation of tumor lysate and who have tumors that express tyrosinase or gp100 with types HLA-A1, A2, or A3. Group B consists of the patients who have adequate tumor for lysate preparation but who do not type for HLA-A1, A2, or A3 (required for the peptide pulsed protocol). Group C are the patients with adequate tumor who are eligible for the peptide pulsed protocol. Group A patients receive autologous dendritic cells pulsed with appropriate peptide antigens. Group B patients are treated with autologous dendritic cells pulsed with autologous tumor cell lysates. Group C patients are randomized to receive dendritic cells pulsed with either peptide antigens or tumor lysate. All patients are administered intravenous active immunotherapy for 4 monthly intervals. The dose of the immunizations is escalated for each cohort of three patients that is accrued in each of the groups mentioned above. Each immunization at each dose level is followed by three days of interleukin-2 administered subcutaneously twice daily. Patients are followed at least 5 years for survival.

PROJECTED ACCRUAL: There will be 100 patients accrued in this study over 2 years. There will be 50, 20, and 30 patients in groups A, B, and C, respectively.

Study Design

Allocation: Randomized, Primary Purpose: Treatment


Melanoma (Skin)


aldesleukin, gp100 antigen, tyrosinase peptide


Duke Comprehensive Cancer Center
North Carolina
United States




National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:58:47-0400

Clinical Trials [2218 Associated Clinical Trials listed on BioPortfolio]

Vaccine Therapy in Treating Patients With Melanoma

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine therapy may be an effective treatment for melanoma. PURPOSE: Randomized phase II trial to study...

Novel Adjuvants for Peptide-Based Melanoma Vaccines

This is a study to determine the efficacy of a melanoma vaccine chemotherapy cocktail composed of CTLA-4 antibody; tyrosinase, gp100, and MART-1 peptides; and incomplete Freund's adjuvant ...

A Phase I Study of gp100 Human Melanoma Peptide Vaccine With Incomplete Freund's Adjuvant

This is a phase I study of melanoma tumor antigen peptide vaccines. The nine amino acid peptides representing HLA-A2 restricted T cell epitope of the melanoma antigen, gp100 will be admin...

Vaccine Therapy Plus Immune Adjuvants in Treating Patients With Advanced Melanoma

RATIONALE: Vaccines made from peptides that are found on melanoma cells may make the body build an immune response and kill melanoma cells. Combining vaccine therapy with immune adjuvants,...

Vaccine Therapy in Treating Patients With Melanoma of the Eye

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells and decrease the recurrence of melanoma of the eye. PURPOSE: Randomized phase III trial to determine the...

PubMed Articles [7686 Associated PubMed Articles listed on BioPortfolio]

A Fluorescent Probe for Early Detection of Melanoma and Its Metas-tasis through Specifically Imaging Tyrosinase Activity in Mouse Model.

Melanoma is a type of highly malignant and metastatic skin cancer, and early detection of melanoma by analyzing the level of its biomarker may decrease the likelihood of mortality. In this study, a fl...

Anti-melanogenesis potential of a new series of Morita-Baylis-Hillman adducts in B16F10 melanoma cell line.

Melanin is a natural polymer pigment which provides skin photoprotection against ultraviolet radiation. An excessive synthesis of melanin leads to hyperpigmentation disorders. Tyrosinase catalyzes the...

Peptide-modified vemurafenib-loaded liposomes for targeted inhibition of melanoma via the skin.

Vemurafenib is a chemotherapeutic drug recently approved by the FDA to treat melanoma. Because the drug is usually delivered orally, the route of administration readily causes damage to major organs w...

Identification of the Risk HLA-A Alleles and Autoantigen in Han Chinese Vitiligo Patients and the Association of CD8+T Cell Reactivity with Disease Characteristics.

BACKGROUND Multiple studies have implicated a role for CD8+T cell-mediated immune response to autoantigens in vitiligo. However, the antigen-specific T lymphocyte reactivity against the peptide epitop...

Melanoma-related changes in skin microbiome.

Melanoma is the least common form of skin tumor, but it is potentially the most dangerous and responsible for the majority of skin cancer deaths. We suggest that the skin microbiome might be changed d...

Medical and Biotech [MESH] Definitions

A melanosome-specific protein that plays a role in the expression, stability, trafficking, and processing of GP100 MELANOMA ANTIGEN, which is critical to the formation of Stage II MELANOSOMES. The protein is used as an antigen marker for MELANOMA cells.

A melanosome-associated protein that plays a role in the maturation of the MELANOSOME.

Heterogeneous group of autosomal recessive disorders comprising at least four recognized types, all having in common varying degrees of hypopigmentation of the skin, hair, and eyes. The two most common are the tyrosinase-positive and tyrosinase-negative types.

An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)

A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.

More From BioPortfolio on "Vaccine Therapy in Treating Patients With Metastatic Melanoma Who Are Undergoing Surgery for Lymph Node and Tumor Removal"

Quick Search


Relevant Topics

Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells.  In vertebrates, it is composed of blo...

  Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Searches Linking to this Trial