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.

T Cell Response and Function in Peripheral Blood

Overall Study

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

Gemcitabine

Endothelial Growth Factors

Mitogens

Pancrelipase

Monatide (IMS 3015)

Pancreatin

Adjuvants, Immunologic

HLA-A\*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084) 1mg emulsified with Montanide ISA51 will be subcutaneously injected 2 times weekly for total 16doses concurrently with conventional dose of gemcitabine 1,000mg/m2 BSA on 1st, 2nd, 3rd, 5th, 6th, 7th weeks for advanced/inoperable pancreatic cancer patients.

VEGFR1-A24-1084 (SYGVLLWEI)

Naohide Yamashita, MD, PhD

Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.

Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively.

HLA-A\*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).

HLA-A\*2402-restricted cytotoxic T lymphocyte (CTL) clones were obtained from healthy volunteer donor peripheral blood.

These CTL clones showed potent cytotoxicities selectively against VEGFR1-expressing target cells in HLA-class I-restricted manner.

Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

Phase Ⅰ/Ⅱ Trial of Human Leukocyte Antigen (HLA)-A*2402-Restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Gemcitabine for Advanced Pancreatic Cancer

Human Genome Center, Institute of Medical Science, University of Tokyo

Tokyo University

Naohide Yamashita MD, PhD

VEGFR1-derived HLA-A\*02:01-restricted peptide (VEGFR1-A2-770; TLFWLLLTL)was vaccinated twice weekly for 8 weeks (total 16 doses) combined with conventional dose (1,000 mg/m\^2 body surface area) of gemcitabine 6 doses for advanced stage pancreatic cancer to confirm the safety and efficacy of this type of peptide.

VEGFR1-derived HLA-A\*02:01-restricted peptide (VEGFR1-A2-770; TLFWLLLTL)was vaccinated twice weekly for 8 weeks (total 16 doses) combined with conventional dose (1,000 mg/m\^2 body surface area) of gemcitabine 6 doses for advanced stage pancreatic cancer to confirm the feasibility and efficacy of this type of peptide.

HLA-A*02:01-restricted VEGFR1-derived peptide vaccination

Pancreatic cancer is the fourth leading cause of cancer death in the United States, and no combination therapy is far superior to gemcitabine alone. Vascular endothelial growth factor receptor type 1 (VEGFR1) is expressed on the tumor vessels and a candidate of tumor vessel-specific peptide vaccination strategy to induce T cell immune response. We conducted the study to confirm the safety and efficacy of combined modality intervention using conventional dose of gemcitabine with peptide vaccination targeting tumor-vessel specific VEGFR1 in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.

Gemcitabine 1,000 mg/m\^2 (body surface area) will be administered on day 1, day 8, day 15, day 29, day 36, and day 43, respectively.

VEGFR1-derived HLA-A\*02:01-restricted peptide (VEGFR1-A02-770; TLFWLLLTL) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8 weeks (total 16 doses).

HLA-A\*02:01-restricted VEGFR1-specific cytotoxic T lymphocyte (CTL) responses were obtained from HLA-A2/Kd transgenic murine model.

HLA-A\*02:01-restricted VEGFR1-specific CTL clones were also obtained from peripheral blood mononuclear cells of healthy volunteer donors.

These CTL clones showed potent anti-tumor CTL responses in HLA class Ⅰ-restricted manner in vitro.

Vaccination of HLA-A\*02:01-restricted VEGFR1-specific peptide to A2/Kd transgenic mice markedly suppress the tumor-induced angiogenesis and tumor growth in vivo.

Human Leukocyte Antigen-A*02:01-restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer

Phase I/II Trial of Human Leukocyte Antigen (HLA)-A*02:01-restricted Vascular Endothelial Growth Factor Receptor 1 (VEGFR1)-Derived Peptide Vaccination Combined With Conventional Dose of Gemcitabine for Advanced Pancreatic Cancer

Number of participants without grade 4 hematological or grade 3 other adverse events were caslculated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v.3)

Sum of diameters of primary pancreatic tumor or metastatic tumors (target lesions) before and after vaccination were measured by computed tomography. Sum of tumors' size diameters decrease more than 30% after vaccination was diagnosed as response according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 guidelines.

Naohide Yamashita MD,PhD

Serious adverse events include grade 4 hematological or grade 3 to 4 non-hematological adverse events

HLA-A\*0201-restricted VEGFR1-specific peptide, VEGFR1-A02-770(TLFWLLLTL) 1 mg, subcutaneous injection, twice every weeks for eight weeks (total 16 doses) combined with incomplete Freund adjuvant (IFA) and gemcitabine 1,000 mg/m\^2 of body surface area

Peptide 1 mg Twice Weekly for 8 Weeks With Gemcitabine

Age, Categorical

Age Continuous

Early termination leading to small numbers of subjects analyzed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I/II Trial of a Long Peptide Vaccine (LPV7) Plus TLR Agonists	NCT02126579	Melanoma Metastatic Mela... Mucosal Melanom...	Peptide Vaccine... PolyICLC Resiquimod IFA	18 Years -	University of Virginia
Human Leukocyte Antigen-A*2402-Restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer	NCT00683358	Pancreatic Canc... Pancreas Neopla...	VEGFR1-A24-1084...	20 Years - 85 Years	Tokyo University
Human Leukocyte Antigen-A*02:01-restricted Tumor Vessel Specific Peptide Vaccination for Advanced Pancreatic Cancer	NCT00683085	Pancreatic Canc... Pancreas Neopla...	HLA-A*02:01-res...	20 Years - 85 Years	Tokyo University

Spots Global Cancer Trial Database for ifa

Every month we try and update this database with for ifa cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ifa

Every month we try and update this database with for ifa cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ifa cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.