Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

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Pancreatic Neoplasms

Insulinoma

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Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Gemcitabine

Bortezomib

Pancrelipase

Panobinostat

Pancreatin

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Pancreatic cancer patients who received treatment with bortezomib and panobinostat after progressing on gemcitabine.

1.3 mg/m\^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period

20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period

Arkadiusz Dudek, MD

Cancer results from multiple mutations which cause cells to grow uncontrolled. It therefore may be necessary to inhibit several oncogenic targets to affect cancer cell growth. Studies have shown that panobinostat (LH589) causes a wide range of effect on endothelial cells that lead to inhibition of tumor angiogenesis (a fundamental step in the transition of tumors from a dormant state to a malignant one). Bortezomib triggers cell death in pancreatic cancer cells but the mechanism is not well defined but has been determined to be cytostatic. Combining these two drugs may work together in the treatment of pancreatic cancer.

Panobinostat & Bortezomib in Pancreatic Cancer Progressing on Gemcitabine Therapy

Phase II Study of Panobinostat (LBH589) Given in Combination With Bortezomib (Velcade) in Patients With Pancreatic Cancer Progressing on Gemcitabine Therapy Alone or Gemcitabine in Combination

Median number of months before disease progressed in patient on gemcitabine when treated with the combination of panobinostat and bortezomib. Progression free survival is measured from randomization until the subject has documented disease progression by an objective measure. Subjects must be alive with no more than 20% increase in tumor size to qualify for progression free survival. Changes in tumor size are defined by RECIST criteria.

Number of patients whose tumor has responded to study therapy is determined using Response Evaluation Criteria In Solid Tumors. Progressive Disease (PD) is assessed if the sum of the diameters has increased by ≥ 20% and ≥ 5 mm from nadir (including baseline if it is the smallest sum). Objective response is measured by tumor reduction as defined in the RECIST criteria. Tumor shrinkage must be at least 30% to qualify as an objective response.

Duration of response is calculated as (Date of First Disease Progression or Death as a Result of any Cause whichever Comes First - Date of First Objective Status Assessment of Confirmed Complete or Partial Response as defined by RECIST criteria).

Novartis Pharmaceuticals

Millennium Pharmaceuticals, Inc.

Masonic Cancer Center, University of Minnesota

Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m\^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.

Pancreatic Cancer Patients

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Study was terminated early leading to small numbers of subjects analyzed; no solid conclusion can be derived.

Arkaduisz Dudek, M.D.

Progression-Free Survival

Progressive Disease

No data available

Objective Response

Number of Participants by Tumor Response

Duration of Response

Overall Study

Adenocarcinoma

Vaccines

The using dosage,frequency and duration of cancer stem cell vaccine are still undetermined.

cancer stem cell vaccine

Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors into immunosuppressed mice, preventing an assessment on the immunologic interactions and effects of CSCs. In this study, the investigators examined the vaccination effects produced by CSC-enriched populations from histologically distinct murine tumors after their inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic and more effective as an antigen source than unselected tumor cells in inducing protective antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed antibodies and T cells were capable of selective targeting CSCs and conferring antitumor immunity.

To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the investigators will harvest peripheral blood and tumor specimen from patients with Pancreatic Cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the Pancreatic Cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells from the tumor specimen of the Pancreatic Cancer patient using a similar protocol as investigators reported .

Aim 1: To demonstrate, in vitro, the relative cellular anti-Pancreatic Cancer CSC immunity induced by Pancreatic Cancer CSC-DC primed cytotoxic T cells.

Aim 2: To determine, in vitro, specific binding and lysis of Pancreatic Cancer CSCs by antibodies produced by purified B cells from PBMCs stimulated with Pancreatic Cancer CSC-DC.

Safety Study of Cancer Stem Cell Vaccine to Treat Pancreatic Cancer

Study of Cancer Stem Cell Vaccine That as a Specific Antigen in Metastatic Adenocarcinoma of the Pancreas

University of Michigan

Fuda Cancer Hospital, Guangzhou

Endothelial Growth Factors

Mitogens

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

Naohide Yamashita, MD, PhD

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.

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

Tokyo University

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 Continuous

Early termination leading to small numbers of subjects analyzed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Panobinostat & Bortezomib in Pancreatic Cancer Progressing on Gemcitabine Therapy	NCT01056601	Pancreatic Canc...	Bortezomib Panobinostat	18 Years -	Masonic Cancer Center, University of Minnesota
Safety Study of Cancer Stem Cell Vaccine to Treat Pancreatic Cancer	NCT02074046	Neoplasms, Panc...	cancer stem cel...	18 Years - 75 Years	Fuda Cancer Hospital, Guangzhou
Safety Study of Cancer Stem Cell Vaccine to Treat Pancreatic Cancer	NCT02074046	Neoplasms, Panc...	cancer stem cel...	18 Years - 75 Years	Fuda Cancer Hospital, Guangzhou
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
Safety Study of Cancer Stem Cell Vaccine to Treat Pancreatic Cancer	NCT02074046	Neoplasms, Panc...	cancer stem cel...	18 Years - 75 Years	Fuda Cancer Hospital, Guangzhou

Spots Global Cancer Trial Database for neoplasms, pancreas