Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Uterine Cervical Neoplasms

Neoplasm Metastasis

Lung Neoplasms

Neoplastic Processes

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Analgesics

Vaccines

Cyclophosphamide

Interleukin-2

cyclophosphamide dose escalation, level 1:150mg/m2,level 2: 300mg/m2, level 3: 300mg/m2x2, with 5 kinds o tumor specific antigen peptides followed by low dose IL-2, 6 patients will be enrolled for each level.

1mg each of 5 peptides with IFA. 4 weekly s.c. administration.

5 peptide vaccines of KOC1, TTK, CO16, DEPDC1, MPHOSPH1

Kenzaburo Tani, MD,phD

The purpose of this study is to evaluate the clinical safety and efficacies of cyclophosphamide combined cancer specific epitope peptides cocktail for advanced/relapsed solid tumors including GI/lung/cervical cancers

KOC1, TTK, CO16(URLC10), DEPDC1, MPHOSPH1 have been identified using genome-wide expression profile analysis by the use of cDNA microarray in the previous studies. The investigators have determined the HLA-A\*2402 restricted epitope peptides respectively derived from KOC1, TTK, CO16(URLC10), DEPDC1, and MPHOSPH1 showed strong INF-gamma production when stimulated with the appropriate targets expressing the appropriate protein and HLA-A\*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore the investigators focused on the prevention of further expansion of the solid tumors highly expressing these 5 proteins using these 5 peptides.

Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors

Phase I Study of Tumor Specific Potentiated Vaccine Therapy Using Cyclophosphamide Combined Epitope Peptide Cocktail for Progressive/Relapsed Solid Tumors(GI/Lung/Cervical Cancer)

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

Kyushu University

Department of Advanced Molecular and Cell Therapy

Digestive System Diseases

Rare Diseases

Recurrence

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Fluorouracil

Cisplatin

Monatide (IMS 3015)

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Escalating dose of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 will be administered by subcutaneous injection on days 15, 22, 28 and 35 of treatment cycle. Doses of each peptide are planning 0.5mg, 1mg and 3mg/body. Chemotherapy plus radiation therapy will be done as follows: fluorouracil (400mg/m2) on day1-5 and 8-12, cisplatin (40mg/m2) on days 1 and 8, radiation (2Gy) on days 1-5, 8-12 and 15-19. Two cycles of combination of chemoradiation therapy and epitope peptide vaccine therapy will be done.

URLC10, TTK, KOC1, VEGFR1, VEGFR2, cisplatin, fluorouracil

Hisae Iinuma, PhD

Kota Okinaga, MD, PhD

The purpose of this study is to evaluate the safety and immune response of multiple peptides (URLC10, TTK, KOC1 VEGFR1, and VEGFR2) emulsified with Montanide ISA51 in combination with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.

Up-regulated ling cancer 10 (URLC10), TTK protein kinase (TTK) and K homology domain containing protein over expressed in cancer (KOC1) were identified as new targets of tumor associated antigens using cDNA microarray technologies combined with the expression profiles of normal and cancer tissues. Furthermore, anti-angiogenic therapy is now considered to be one of promising approaches for treating cancer. Vascular endothelial growth factor receptor 1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) are essential targets for tumor angiogenesis. Epitope peptides for these targets are able to induce cytotoxic T lymphocytes (CTL) restricted to HLA-A \*2402 in vivo. On the other hand, chemotherapy (CDDP, 5-FU) plus radiation therapy has been to be a standard treatment for unresectable advanced esophageal cancer. In this clinical trial, we evaluate the safety and immune responses of different doses of multiple peptides (URLC10, TTK, KOC1, VEGFR1, and VEGFR 2) emulsified with Montanide ISA 51 in combination with chemotherapy (CDDP, 5-FU) plus radiation therapy in treating patients with unresectable, advanced or recurrent esophageal cancer.

Combination of Chemoradiation Therapy and Epitope Peptide Vaccine Therapy in Treating Patients With Esophageal Cancer

Phase I Study of Chemoradiation Therapy With Epitope Peptide Vaccine Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer

Teikyo University

Department of Surgery

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

DEPDC1-9-294, and/or MPHOSPH1-9-278 will be administered by subcutaneously injection once every week for 3 months thereafter once two weeks. These peptides are determined to administer in accordance with the protein expression using immunohistochemical staining. These peptides are conjugated with Montanide ISA 51 as an adjuvant.

MPHOSPH1 and DEPDC1

Tomoaki Fujioka, M.D. & Ph.D.

The purpose of this study is to evaluate the safety and clinical efficacy of novel vaccination for advanced bladder cancer.

DEP domain containing 1(DEPDC1) and M phase phosphoprotein 1(MPHOSPH1) have been identified using genome-wide expression profile analysis by the use of cDNA microarray in our previous studies. We have determined the HLA-A\*2402 restricted epitope peptides derived from DEPDC1, DEPDC1-9-294, and MPHOSPH1, MPHOSPH1-9-278. These epitopes showed strong IFN-g production when stimulated with the appropriate targets expressed the appropriate protein and HLA-A\*2402. Furthermore, when vaccinated these peptides, specific CTLs were determined after the vaccination. Therefore we focused on the safety and efficacy of novel vaccination for the advanced bladder cancer patients who already showed resistance to standard chemotherapies or radiotherapy.

Novel Peptide Vaccination for Patients With Advanced Bladder Cancer

Phase I Study of Vaccination With MPHOSHP1 and DEPDC1 Derived Epitope Peptides for HLA-A-24-positive Patients With Advanced Bladder Cancer

Iwate Medical University

Department of Urology

Gland and Hormone Related Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Testicular Neoplasms

Each of three peptides (1mg) mixed with IFA (1ml) were injected every week at five round.

peptide

Koji Kono, MD,PhD

Koji Kono, MD, PhD

Koji Kono, MD.PhD

The purpose of this study is to evaluate overall survival and immunological monitoring for peptide vaccination therapy using novel cancer testis antigens for locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).

The phase I vaccination study using peptides derived from TTK, LY6K, and IMP-3 for locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who had failed for the standard therapy indicated that the vaccine treatment were well tolerated and feasible, and that antigen-specific T cell responses were strongly induced by the vaccination with some objective clinical responses. Thus, we are currently initiating the randomized phase II clinical vaccination study for the same cohort with ESCC to evaluate the survival benefit of the cancer vaccination.

A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer

Phase II Multicenter Trial of Peptide Vaccination Therapy Using Novel Cancer Testis Antigens for Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

University of Yamanashi

First Department of Surgery

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gemcitabine

Angiogenesis Inhibitors

One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 in group A, on days 3, 10, 17, 24 in group B, or 5, 12, 19, 26 in group C

VEGFR1-1084, VEGFR2-169

Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17

Mitsukazu Gotoh, M.D. & Ph.D

The purpose of this study is to evaluate the safety, and tolerability of HLA-A\*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine

Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine

Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)

Phase Ｉ/Ⅱ Sturdy on Antiangiogenic Vaccine Therapy Using Epitope Peptide Derived From VEGFR1 and VEGFR2 With Gemcitabine in Treating Patients With Unresectable, Recurrent, or Metastatic Pancreatic Cancer

Fukushima Medical University

Assistant professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of Cancer Specific Epitope Peptides Cocktail for Cervical, GI, and Lung Tumors	NCT00676949	Metastatic Tumo...	5 peptide vacci...	20 Years - 80 Years	Kyushu University
Combination of Chemoradiation Therapy and Epitope Peptide Vaccine Therapy in Treating Patients With Esophageal Cancer	NCT00632333	Esophageal Canc...	URLC10, TTK, KO...	20 Years - 80 Years	Teikyo University
Novel Peptide Vaccination for Patients With Advanced Bladder Cancer	NCT00635336	Bladder Cancer	MPHOSPH1 and DE...	20 Years - 80 Years	Iwate Medical University
A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer	NCT00995358	Esophageal Canc...	peptide	20 Years - 80 Years	University of Yamanashi
A Study With Peptide Vaccination in Treating Patients With Esophageal Cancer	NCT00995358	Esophageal Canc...	peptide	20 Years - 80 Years	University of Yamanashi
Combination of Chemoradiation Therapy and Epitope Peptide Vaccine Therapy in Treating Patients With Esophageal Cancer	NCT00632333	Esophageal Canc...	URLC10, TTK, KO...	20 Years - 80 Years	Teikyo University
Novel Peptide Vaccination for Patients With Advanced Bladder Cancer	NCT00635336	Bladder Cancer	MPHOSPH1 and DE...	20 Years - 80 Years	Iwate Medical University
Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)	NCT00655785	Pancreatic Canc...	VEGFR1-1084, VE... Gemcitabine	20 Years - 80 Years	Fukushima Medical University

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