Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Anti-Infective Agents

Gastrointestinal Agents

Antineoplastic Agents

Vaccines

Immunomodulating Agents

Poly ICLC

Adjuvants, Immunologic

Poly I-C

Carboxymethylcellulose Sodium

Immunologic Factors

Interferons

Laxatives

Cathartics

Antiviral Agents

NPVAC1： NPVAC1 drug products are composed of 5 peptides from the HCMV warehouse， NPVAC1 vaccine will be applied before maintenance TMZ cycles after completion of chemoradiation therapy (CRT). Beginning on day 14 before the first maintenance TMZ cycle, patients will receive 7 vaccinations with NPVAC1 drug products during 6 weeks. 400 μg per peptide per vial are used.

Poly-ICLC:

Poly-ICLC（500ug）will be used as immunomodulator with all vaccinations.

NeoPep Vaccine1 plus Poly-ICLC

NPVAC2： NPVAC2 will be ready for use 2 months after enrollment, as these peptides have to be newly synthesized for each patient following identification of the mutanome and corresponding mutated peptides in the HLA ligandome. NPVAC2 drug products are composed 20 peptides de novo synthesized for an individual patient. Patients will be repeatedly vaccinated with NPVAC2 drug products beginning on day 33 of the 6 maintenance TMZ cycle.Patients will receive 9 vaccinations within 12 weeks. 400 μg per peptide per vial are used.

Poly-ICLC:

Poly-ICLC（500ug）will be used as immunomodulator with all vaccinations.

NeoPep Vaccine2 plus Poly-ICLC

Lei Li, Phd

Liang Gao, Phd

The primary objective of this study is to assess the safety and tolerability, feasibility of the NeoPep Vaccine in newly diagnosed glioblastoma (GB) patients.

This is a signelcenter, open-label, single arm, first-in-human phase I trial to investigate the safety, feasibility and immune response of the novel NeoPep Vaccine in patients with newly diagnosed GB.

Primary Endpoints:

Determine the safety and tolerability profile of NeoPep Vaccine1and 2 when administered with immunomodulators and Stupp standard treatment

Secondry Endpoints:

1. Descriptive analysis of induced T-cell immune responses after vaccinations with NeoPep Vaccine1and 2 drug products plus immunomodulators and Stupp standard treatment.
2. Overall survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.
3. Progression-free survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.

After the standard chemoradiotherapy with TMZ has been completed, Vaccination was initiated 14 days before the first maintenanceTMZ cycle. It starts with the first NeoPep Vaccine1, followed by additional NeoPep Vaccine2 at a later time point and ends with the Last Endpoint Evaluation Visit (LEEV) of a patient.

Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients

Clinical Study on the Effect of Neoantigens on the Therapeutic Efficacy and Intestinal Microbiota in Patients With Newly Diagnosed Glioma

Determine the safety and tolerability profile of NeoPep Vaccine1and 2 when administered with immunomodulators and Stupp standard treatment

Descriptive analysis of induced T-cell immune responses after vaccinations with NeoPep Vaccine1and 2 drug products plus immunomodulators and Stupp standard treatment.

Overall survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.

Progression-free survival with NeoPep Vaccine1 and 2 plus immunomodulator in newly diagnosed glioma in patients treated with standard Stupp.

Hangzhou NeoVax Biotechnology Co. Ltd.

Shanghai 10th People's Hospital

Neurosurgery department

Blood and Lymph Conditions

Immune System Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Lymphosarcoma

Mercaptopurine

Antimetabolites

Immunosuppressive Agents

Enzyme Inhibitors

6-mercaptopurine was administered according to the Chinese Children Cancer Group (CCCG) protocol-ALL 2015.

6-mercaptopurine was administered on the basis of Chinese Children Cancer Group (CCCG) protocol-ALL 2015 combined with Clinical Pharmacogenetics Implementation Consortium (CPIC), genotypes and the concentrations of 6-TGN in red blood cells.

6-mercaptopurine was administered orally to patients once daily.

6-mercaptopurine

The initial dose is 50mg/m2. The dose was adjusted according to white blood cells.

Standard treatment

The initial dose is determined according to the genotypes of patients combined with Clinical Pharmacogenetics Implementation Consortium (CPIC). The dose was adjusted according to white blood cells, genotypes and the concentrations of 6-TGN in red blood cells.

Individualized treatment

Wei Zhao, Ph.D

Yan H Shi, Ph.D

The purpose of this study was to assess the efficacy and safety of individualized treatment of 6-mercaptopurine (6-MP) in Chinese children with acute lymphoblastic leukemia, and to investigate the dose-concentration-response (DER) relationship between thiopurine metabolites and adverse events. The individualized administration of 6-MP was established in Chinese children with acute lymphoblastic leukemia.

To inflict minimal pain on the child contributing blood samples, opportunistic sampling design was chosen to collect pharmacokinetic samples.

The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China

Leukopenia was graded by common toxicity criteria as follows: Grade 3, 1.0-2.0 × 109/L, and Grade 4, \< 1.0 × 109/L.

Resolution of leukopenia was determined after 6-MP dose reduction or discontinuation, both in the absence of other apparent causes for the leukopenia or its disappearance.

Hepatotoxicity was defined as aspartate aminotransferase (AST) or alanine transaminase (ALT) levels 2-fold above the upper limit without cytolysis.

Peripheral blood samples were obtained from steady-state plasma concentrates by opportunistic sampling design.

Institute of Hematology & Blood Diseases Hospital, China

Qianfoshan Hospital

Qilu Hospital of Shandong University

Children's Hospital of Hebei Province

The Affiliated Hospital of Qingdao University

Wei Zhao

Professor; Head of department of clinical pharmacy and pharmacology

Gland and Hormone Related Diseases

Digestive System Diseases

Thyroid Neoplasms

Thyroid Diseases

Colonic Neoplasms

Endocrine System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Thyroid Cancer, Medullary

Herbal and Botanical

Cola

Personalized Therapy Plan Patients with Metastatic Medullary or Colon Cancer being treated with the Personalized Treatment Plan developed during the different tumor genomic analysis study.

Tumor mutations identified by deep DNA and RNA sequencing of individual tumors are screened for tumor drivers, which are then incorporated into the "personal" Drosophila model and tested against a library of FDA approved drugs. Fly mortality is used as a surrogate for toxicity and increased survival to adulthood; improvements in tumor mutation-linked eye and/or wing abnormalities serve to quantify efficacy. This allows rapid and parallel screening of FDA approved drugs and subsequent drug combinations. The most efficacious and least toxic combinations are tested in xenograft models and a multidisciplinary tumor board of experts select the best therapeutic option. The objective is to demonstrate that the personalized drosophila model approach is superior to the current standard. Patient will be offered an unique "personalized" single drug or combination of drugs, all FDA approved, based on the Drosophila drug screening process.

Tumor Genomic Analysis

Krzysztof Misiukiewicz, MD

The Personalized Discovery Process is the only program offering patients treatment recommendations based on an empirically constructed Drosophila "fly" model of their disease. Special committee selects one of the one of the few 2-3 FDA approved drug combinations or single agents that improved survival in the fly cancer model.

Tumor mutations identified by deep DNA and RNA sequencing of individual tumors are screened for tumor drivers, which are then incorporated into the "personal" Drosophila model and tested against a library of FDA approved drugs. Fly mortality is used as a surrogate for toxicity and increased survival to adulthood; improvements in tumor mutation-linked eye and/or wing abnormalities serve to quantify efficacy. This allows rapid and parallel screening of FDA approved drugs and subsequent drug combinations. The most efficacious and least toxic combinations are tested in xenograft models and a multidisciplinary tumor board of experts select the best therapeutic option. The objective is to demonstrate that the personalized drosophila model approach is superior to the current standard used in medullary thyroid or colorectal cancer.

Personalized Cancer Therapy for Patients With Metastatic Medullary Thyroid or Metastatic Colon Cancer

ORR as the sum of partial responses (PRs) and complete responses (CRs)

The length of time during and after the treatment of disease that a patient lives with the disease but it does not get worse.

The length of time from either the date of diagnosis or the start of treatment for disease, that patients diagnosed with the disease are still alive.

Icahn School of Medicine at Mount Sinai

Assistant Professor, Medicine, Hematology and Medical Oncology

Heart and Blood Diseases

Symptoms and General Pathology

Carcinoma

Hypertension

Hypertension, Portal

Hemorrhage

Varicose Veins

Splenomegaly

Vascular Diseases

Liver Diseases

Oxaliplatin

Patients under evaluation including hepatic venous pressure gradient (HVPG) and contrast-enhanced computed tomography of portal venous. For those patients with a HVPG ≥12mmHg or with extraluminal para-gastric vein will under transjugular intrahepatic portosystemic shunt and others receive endoscopic treatment.

Individualized Treatment

Xiaoquan HUANG

Shiyao CHEN

Oxaliplatin has been used as the first choice for the adjuvant chemotherapy of colorectal cancer and it has significantly improved the outcomes in patients with colorectal cancer. However, hepatotoxicity is the potentially problematic adverse effect of oxaliplatin. The pathological evaluation of non-tumoral liver from patients with advanced colorectal cancer undergoing neoadjuvant oxaliplatin-based treatment has provided histological evidence of hepatic sinusoidal injury. Oxaliplatin-induced sinusoidal injury can persist for more than 1 year after the completion of chemotherapy, and the increase in splenic volume may be a predictor of irreversible sinusoidal damage. In this current study, we aim to evaluate the efficacy of individualized treatment in patients with oxaliplatin-induced gastroesophageal varices after colorectal cancer surgery.

Oxaliplatin-induced Portal Hypertension

Construction and Evaluation of the Early Identification and Individualized Treatment for Oxaliplatin-induced Portal Hypertension

The occurrence of complications of portal hypertension including ascites, liver failure, et al.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients	NCT05557240	Glioma, Maligna... Antigen-specifi... Individualized ...	NeoPep Vaccine1... NeoPep Vaccine2...	18 Years - 70 Years	Shanghai 10th People's Hospital
The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China	NCT04228393	Acute Lymphobla...	6-mercaptopurin... Standard treatm... Individualized ...	1 Year - 18 Years	Shandong University
Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients	NCT05557240	Glioma, Maligna... Antigen-specifi... Individualized ...	NeoPep Vaccine1... NeoPep Vaccine2...	18 Years - 70 Years	Shanghai 10th People's Hospital
The Individualized Treatment of 6-mercaptopurine in Children With Acute Lymphoblastic Leukemia in China	NCT04228393	Acute Lymphobla...	6-mercaptopurin... Standard treatm... Individualized ...	1 Year - 18 Years	Shandong University
Personalized Cancer Therapy for Patients With Metastatic Medullary Thyroid or Metastatic Colon Cancer	NCT02363647	Medullary Thyro... Colon Cancer	Tumor Genomic A...	18 Years -	Icahn School of Medicine at Mount Sinai
Oxaliplatin-induced Portal Hypertension	NCT04524676	Gastroesophagea... Colorectal Canc... Received Oxalip...	Individualized ...	18 Years - 75 Years	Shanghai Zhongshan Hospital
Neoantigens Phase I Trial in Newly Diagnosed Glioblastoma Patients	NCT05557240	Glioma, Maligna... Antigen-specifi... Individualized ...	NeoPep Vaccine1... NeoPep Vaccine2...	18 Years - 70 Years	Shanghai 10th People's Hospital

Spots Global Cancer Trial Database for individualized treatment