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

Freund's Adjuvant

Resiquimod

Immunomodulating Agents

Immunologic Factors

Interferons

Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after the vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + IFA + PolyICLC vaccines administered in one skin location. Each vaccine will be administered in the same skin site for all 6 vaccines.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

1.5 mL administered half intradermally and half subcutaneously.

Peptide Vaccine (LPV7) + Tetanus peptide

1 mL administered half intradermally and half subcutaneously

PolyICLC

500 mg applied to vaccine site after vaccine administration

2 mL administered half intradermally and half subcutaneously

Craig L Slingluff, Jr., M.D.

The purpose of this study is to learn what effects (good and bad) an experimental vaccine (LPV7) plus tetanus peptide and other substances called polyICLC, resiquimod, and Montanide ISA-51 have on you and your melanoma. We will also look at whether the experimental vaccine and these drugs cause any changes in your immune system.

Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists

Open Label, Randomized, Phase I/II Study of a Long Peptide Vaccine Plus TLR Agonists for Resected Stage IIb-IV Melanoma. (MEL60)

Safety and toxicity following vaccination with 7 long peptides in melanoma patients with and without TLR agonists.

Patients are evaluated by safety labs and physical exams to assess for toxicity.

Levels of peptide-reactive CD8+ T cells in the peripheral blood: number of participants with T cell response to minimal epitope for CD8 T cells. This was assessed by direct (ex vivo) IFN-gamma ELIspot assay for reactivity to known minimal epitopes. To be considered positive, there had to be an increase compared to the maximum negative control target by at least 2-fold and by at least 20 IFN-gamma secreting cells per 100,000 CD8 T cells evaluated.

CD4+ T cell responses to peptides in the vaccine, and their function

University of Virginia

Craig L Slingluff, Jr

Professor, Department of Surgery

All adverse events (treatment-related or not), All serious adverse events (treatment-related or not), and All Cause Mortality on study

Peptide Vaccine (LPV7) + Tetanus peptide + IFA administered in one skin location rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

IFA: 2 mL administered half intradermally and half subcutaneously

Arm A (Part 1)

Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Arm B (Part 1)

Peptide Vaccine (LPV7) + Tetanus peptide vaccine administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after the vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration

Arm C (Part 1)

Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration

Arm D (Part 1)

Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously

Except that one participant on Part 2 did not have tetanus peptide in the vaccine, and that participants vaccines were all administered at the same vaccine site.

Arm E (Part 1 + 2)

Peptide Vaccine (LPV7) + Tetanus peptide + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously

Arm F (Part 1)

Peptide Vaccine (LPV7) + Tetanus peptide + PolyICLC + IFA vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Resiquimod will be applied to the vaccine site immediately after vaccine administration.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

Resiquimod: 500 mg applied to vaccine site after vaccine administration

IFA: 2 mL administered half intradermally and half subcutaneously

Arm G(Part 1)

Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously.

Except that the last patient, on Part 2 received all 6 vaccines in the same site and did not receive tetanus peptide.

Total

Median Age

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Craig Slingluff, MD; Professor, Department of Surgery; Program Director, UVA Cancer Center

BLOOD/LYMPHATIC - Other

EAR/LABYRINTH - Tinnitus

GASTROINTESTINAL - Constipation

GASTROINTESTINAL - Diarrhea

GASTROINTESTINAL - Mucositis oral

GASTROINTESTINAL - Nausea

GASTROINTESTINAL - Other

GASTROINTESTINAL - Vomiting

GENERAL AND ADMINISTRATION SITE - Chills

GENERAL AND ADMINISTRATION SITE - Fatigue

GENERAL AND ADMINISTRATION SITE - Fever

GENERAL AND ADMINISTRATION SITE - Flu like symptoms

GENERAL AND ADMINISTRATION SITE - Injection site reaction

GENERAL AND ADMINISTRATION SITE - Localized edema

GENERAL AND ADMINISTRATION SITE - Other

GENERAL AND ADMINISTRATION SITE - Pain

IMMUNE SYSTEM - Autoimmune disorder

INJURY/POISONING/PROCEDURAL - Bruising

INVESTIGATIONS - Lymphocyte count decreased

INVESTIGATIONS - Weight loss

INVESTIGATIONS - White blood cell decreased

METABOLISM/NUTRITION - Anorexia

MUSCULOSKELETAL/CONNECTIVE TISSUE - Arthralgia

MUSCULOSKELETAL/CONNECTIVE TISSUE - Generalized muscle weakness

MUSCULOSKELETAL/CONNECTIVE TISSUE - Myalgia

MUSCULOSKELETAL/CONNECTIVE TISSUE - Pain in extremity

MUSCULOSKELETAL/CONNECTIVE TISSUE - Other

NERVOUS SYSTEM - Dizziness

NERVOUS SYSTEM - Dysgeusia

NERVOUS SYSTEM - Headache

PSYCHIATRIC - Anxiety

RESPIRATORY/THORACIC/MEDIASTINAL - Allergic rhinitis

RESPIRATORY/THORACIC/MEDIASTINAL - Cough

RESPIRATORY/THORACIC/MEDIASTINAL - Dyspnea

RESPIRATORY/THORACIC/MEDIASTINAL - Sore throat

SKIN/SUBCUTANEOUS TISSUE - Hyperhidrosis

SKIN/SUBCUTANEOUS TISSUE - Pain of skin

SKIN/SUBCUTANEOUS TISSUE - Pruritus

SKIN/SUBCUTANEOUS TISSUE - Rash maculo-papular

SKIN/SUBCUTANEOUS TISSUE - Scalp pain

SKIN/SUBCUTANEOUS TISSUE - Skin hyperpigmentation

SKIN/SUBCUTANEOUS TISSUE - Skin hypopigmentation

SKIN/SUBCUTANEOUS TISSUE - Skin induration

SKIN/SUBCUTANEOUS TISSUE - Skin ulceration

VASCULAR - Flushing

VASCULAR - Hot flashes

VASCULAR - Other

DLTs

Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma (except that the vaccines were administered to the same skin site for the one patient from cohort 2)

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously. (except that the tetanus peptide was not included in the vaccine for the one patient on this arm from cohort 2.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously

Arm E (Part 1 + Part 2)

Number of Participants With Treatment-related Adverse Events Per Study Arm

Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously

Except that one patient, on Part 2, received all 6 vaccines in the same skin site, and did not have tetanus peptide in the vaccine.

Arm E (Part 1)

T Cell Response in Peripheral Blood Over Duration of Study Participation

Peptide Vaccine (LPV7) + Tetanus peptide + IFA + PolyICLC vaccines administered in one skin location that is rotated to different sites on an extremity clinically uninvolved with melanoma.

Vaccines will be administered on Days 1, 8, 15, 36, 57, and 78.

Peptide Vaccine (LPV7) + Tetanus peptide: 1.5 mL administered half intradermally and half subcutaneously.

PolyICLC: 1 mL administered half intradermally and half subcutaneously

IFA: 2 mL administered half intradermally and half subcutaneously

Except that one participant on Arm E was on Part 2, where all vaccines were administered at the same vaccine site, and the tetanus peptide was not included in the vaccines.

Spots Global Cancer Trial Database for freund's adjuvant