Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Vaccines

Poly ICLC

Interferons

Immunologic Factors

- NeoVax (peptides + poly-ICLC)

Poly-ICLC: 4 x 0.5 mg (total dose 2 mg) given on days Days 1, 4, 8, 15, 22, 78, and 162

Peptides: 4 x 300 mcg per peptide given on days Days 1, 4, 8, 15, 22, 78, and 162

Poly-ICLC

Peptides

Patrick Ott, MD, PhD

This research study is evaluating a new type of melanoma vaccine called "Personalized NeoAntigen Cancer Vaccine". The purpose of this study is to determine if it is possible to make and administer safely a vaccine against melanoma by using information gained from specific characteristics of the participant's own melanoma. It is known that melanomas have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the melanoma to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.

A Phase I Study With a Personalized NeoAntigen Cancer Vaccine in Melanoma

Patrick Ott, MD

Principal Investigator

Analgesics

Molgramostim

Sargramostim

Interleukin-2

Each of the peptides plus tetanus toxoid peptide, plus GM-CSF in adjuvant, administered subcutaneously and intradermally. Systemic low-dose IL-2 will be administered daily for 6 weeks, beginning at week 1 and ending at week 7.

Peptides plus GMCSF-in-adjuvant, with delayed IL-2.

Each of the peptides plus tetanus toxoid peptide, plus GM-CSF in adjuvant, administered subcutaneously and intradermally. Systemic low-dose IL-2 will be administered daily for 6 weeks, beginning at week 4 and ending at week 10.

low-dose IL-2, administered daily for 6 weeks, to begin either at week 1 (group 1) or week 4 (group 2)

low-dose IL-2

six melanoma vaccines given over a 6-week period

melanoma vaccine

Craig L Slingluff, MD

This clinical pilot study will test the hypothesis that systemic low-dose IL-2 therapy significantly enhances the immunologic efficacy of a vaccine comprising melanoma peptides plus GM-CSF-in-adjuvant.

Trial for the Evaluation of the Effect of Systemic Low-dose Interleukin-2 (IL-2) on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered With Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)-In-Adjuvant, in Patients With High Risk Melanoma

Pilot Phase II Trial for the Evaluation of the Effect of Systemic Low-dose IL-2 on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant, in Patients With High Risk Melanoma

University of Virginia

Craig L Slingluff MD

Symptoms and General Pathology

Neoplasm Metastasis

Immunomodulating Agents

Allovectin-7®

The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink melanoma tumors. The trial will also examine if this treatment can improve the time to disease progression.

Treatment - If you take part in this trial you will be treated for about 10 weeks. You will receive an injection of Allovectin-7® by needle, directly into one or more selected tumors once a week for the first six weeks. The injections may be given in a doctor's office. During a four-week observation period, your disease will be measured to see if the treatment is working. This will be done by general physical exams and scans (such as X-ray scans). Patients who show no sign of disease progression may be offered an option to repeat this treatment course.

Phase II Trial of Allovectin-7® for Metastatic Melanoma

A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma

Vical

Dmitri D. Kharkevitch, MD, PhD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase I Study With a Personalized NeoAntigen Cancer Vaccine in Melanoma	NCT01970358	Melanoma	Poly-ICLC Peptides	18 Years -	Dana-Farber Cancer Institute
Trial for the Evaluation of the Effect of Systemic Low-dose Interleukin-2 (IL-2) on the Immunogenicity of a Vaccine Comprising Synthetic Melanoma Peptides Administered With Granulocyte-macrophage Colony-stimulating Factor (GM-CSF)-In-Adjuvant, in Patients With High Risk Melanoma	NCT00928902	Melanoma	low-dose IL-2 melanoma vaccin...	18 Years - 85 Years	University of Virginia
Phase II Trial of Allovectin-7® for Metastatic Melanoma	NCT00044356	Melanoma Metastatic Mela... Malignant Melan... Skin Cancer	Allovectin-7®	18 Years -	Vical

Spots Global Cancer Trial Database for melanoma vaccine