Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Disease Attributes

Neuroepithelioma

All Drugs and Chemicals

Vaccines

Immunomodulating Agents

Autologous DC loaded with a autologous tumor lysate, in order to stimulate the immune response of the patient.

Right after the surgical resection of the recurrent tumor, leukapheresis will be performed.

At least 5x109 PBMC must be collected by leukapheresis, so as to make the whole immunotherapy schedule workable.

Starting at week 3, immunotherapy will include 4 bi-weeekly vaccinations first (injections I, II, III, IV), two further monthly vaccinations (injections V, VI) and a final vaccination (injection VII) two months after the sixth one. Injections I, V, VI and VII will contain 10 million tumor lysate-loaded DC, while the others will be of 5 million cells only.

Vaccine doses will be injected in the forearm of the patient.

Dendritic Cells Vaccine

Rationale of the Study: Treatment for GBM currently consists of surgical resection of the tumour mass followed by radio- and chemotherapy. Nonetheless overall prognosis still remains bleak, recurrence is universal, and recurrent GBM patients clearly need innovative therapies. Dendritic cells (DC) immunotherapy could represent a well-tolerated, long-term tumour-specific treatment to kill all (residual) tumour cells which infiltrate in the adjacent areas of the brain. Preclinical investigations for the development of therapeutic vaccines against high grade gliomas, based on the use of DC loaded with a mixture of glioma-derived tumor have been carried out in rat as well as in mouse models, showing the capacity to generate a glioma-specific immune response. Mature DC loaded with autologous tumor lysate have been used also for the treatment of patients with recurrent malignant brain tumors; no major adverse events have been registered.

Results about the use of immunotherapy for GBM patients are encouraging, but further studies are necessary to find out the most effective and safe combination of immunotherapy with radio- and chemotherapy after exeresis of the tumour mass.

Aim of the study: Primary objective of the study is to evaluate treatment tolerability and to get preliminary information about efficacy. Secondary objective is to evaluate the treatment effect on the immune response. Additional objective is to identify a possible correlation between methylation status of the MGMT promoter and tumor response to treatment.

A two-stage Simon design will be considered for the study. The primary objectives of the study include the evaluation of a PFS6 rate in treated patients. Assuming as outcome measure the percentage of PFS6 patients and of clinical interest an increase to 35% (P1) of the historical control response rate of 20% (P0), the null hypothesis will be rejected (a=0.05, b=0.2) at the end of the first stage if the response rate will be 5/22 treated patients (Fisher's exact test). In the second stage patients will be enrolled up to 72 overall. The study will be successful if at least 19 subjects out of 72 have PFS6 months after the beginning of the treatment.

Study Design: Phase I, 2-stage Simon design (Simon et al., 1997), single-centre, un-controlled, open label, non randomized study.

The therapeutic program will include radical surgical resection of the tumor, followed by immunotherapy. Immunotherapy will comprise 4 biweekly vaccinations first (injections I, II, III, IV), 2 further monthly vaccinations (injections V, VI) and a final vaccination (injection VII) 2 months after the sixth one.

Injections I, V, VI and VII will contain 10 million tumor lysate-loaded DC, while the others will be of 5 million cells only. In correspondence to the third vaccine injection (week 7), 6 cycles of maintenance TMZ (mTMZ) will start. On the basis of the patient clinical status, further vaccine boosts will be considered as appropriate addition at the standard vaccination cycle.

Study Population: The first stage of the study will include 22 patients with recurrent GBM. The overall population at the end of the study will consist of 72 patients.

Phase I, 2-stage Simon design (Simon et al., 1997), single-centre, un-controlled, open label, non randomized study.

Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Recurrence Of Glioblastoma Multiforme

Phase I Clinical Trial Of Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Recurrence Of Glioblastoma Multiforme

PFS-6 is defined as the percentage of participants with PFS at 6 months from the date of surgery for tumor recurrence to the first date of objectively determined progressive disease based on Response Assessment in Neuro-Oncology (RANO) criteria (Wen et al JCO 2010) or death from any cause. It is assumed that PFS follows an exponential distribution. Estimation using Kaplan-Meier analysis.

Tolerability will be assessed using CTCAE version 3.0 and recording incidence, severity and type of adverse events.

Levels of regulatory and CD8+ T cell in treated patients

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Osteosarcoma

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Antineoplastic Agents

Anti-Infective Agents

Gemcitabine

Imiquimod

Immunologic Factors

Antimetabolites

Adjuvants, Immunologic

Interferons

* Leukapheresis: Baseline, post-surgery;
* Dendritic Cells Vaccine (DC Vaccine): Post-Leukapheresis, administered once weekly in dose-escalation scheme for 4 weeks;
* Lysate of Tumor (Lysate): Post-DC Vaccine therapy, administered during weeks 8, 12, 16 and 20;
* Imiquimod: Self-applied topically by subject before and after scheduled DC Vaccine or Lysate administrations.

* Leukapheresis: Baseline, post-surgery;
* Gemcitabine: Post-Leukapheresis, administered once weekly for 3 weeks;
* Dendritic Cells Vaccine (DC Vaccine): Post-Gemcitabine therapy, Recommended Phase 2 Dose (RP2D) administered once weekly for 4 weeks;
* Lysate of Tumor (Lysate): Post-DC Vaccine therapy, administered during weeks 12, 16, 20 and 32;
* Imiquimod: Self-applied topically by subject before and after scheduled DC Vaccine or Lysate administrations.

Subjects will receive DC Vaccine administered once weekly, via intradermal injection, for 4 weeks for a total of four vaccinations, per study protocol.

Post-DC Vaccine therapy. Up to 1.5 mg of Lysate of tumor per dose administered via intradermal injection at intervals defined by study protocol.

Lysate of Tumor

Post-surgery, Leukapheresis and clearance of subject. Gemcitabine 1000 mg/m2 IV will be administered once weekly for 3 weeks per study protocol.

Subjects will self-apply Imiquimod topically to each designated vaccine site before and after scheduled administrations of DC Vaccine or Lysate, per study protocol.

Baseline, post-surgery blood draw via catheter to obtain peripheral blood mononuclear cells (PBMCs) from which Dendritic cells will be obtained.

Leukapheresis

Gina D'Amato, MD

The purpose if this study is to evaluate an investigational vaccine using patient-derived dendritic cells (DC), a type of white blood cell that helps fight infections in the body, (DC) (a vaccine made out of participants' own cells and tumor) to treat sarcoma.

Dendritic Cell Vaccine for Children and Adults With Sarcoma

A Phase I Trial of Dendritic Cell Vaccination for Children and Adults With Sarcoma

To demonstrate that DC vaccination loaded with tumor lysate is feasible and that therapy with the vaccine with topical imiquimod (as final step in vaccine maturation), with or without the inhibition of MDSC by gemcitabine pre-treatment, is safe in pediatric and adult subjects with metastatic and refractory sarcoma.

To explore biomarkers of immune response. Assessment will include measurement of levels of Myeloid Derived Supressor Cells before and after treatment and T and B cell subsets before and after treatment.

To obtain preliminary clinical benefit by evaluating progression-free survival (PFS)in patients receiving this DC vaccine with or without gemcitabine pre-treatment. PFS is defined as the time elapsed from the start of treatment to the date of documented progression or death, whichever comes first. For surviving patients without progression who begin alternative treatment, PFS will be censored at the last date of documented progression-free status prior to starting alternative treatment. Similarly, losses to follow up will be censored at the last date of documented progression-free status.

To obtain preliminary clinical benefit by evaluating overall survival in patients receiving this DC vaccine with or without gemcitabine pre-treatment. Overall survival is defined as the time elapsed from the start of treatment until death. For surviving patients, follow-up will be censored at the date of last contact.

To obtain preliminary clinical benefit by evaluating response rate (RR) in patients receiving this DC vaccine with or without gemcitabine pre-treatment. Response will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria, version 1.1.

To determine if gemcitabine is effective in the inhibition and depletion of Myeloid Derived Supressor Cells in the study patients.

Macarena De La Fuente, MD

Assistant Professor of Clinical

Right after the surgical resection of the tumor, leukapheresis will be performed.

At least 5x109 PBMC must be collected by leukapheresis, so as to make the whole immunotherapy schedule workable.

Immunotherapy will follow radiochemotherapy and will comprise 4 vaccinations every second week (injections I, II, III, IV), 2 further monthly vaccinations (injections V, VI) and a final vaccination (injection VII) 2 months after the sixth one. Injections I, V, VI and VII will contain 10 million tumor lysate-loaded DC, while the others will be of 5 million cells only. In correspondence to the third vaccine injection (week 13), mTMZ will start.

Vaccine doses will be injected in the forearm of the patient.

Marica Eoli, MD

Rationale of the Study: Treatment for GBM currently consists of surgical resection of the tumour mass followed by radio- and chemotherapy ((1)Stupp et al., 2005). Nonetheless overall prognosis still remains bleak, recurrence is universal, and recurrent GBM patients clearly need innovative therapies. Dendritic cells (DC) immunotherapy could represent a well-tolerated, long-term tumour-specific treatment to kill all (residual) tumour cells which infiltrate in the adjacent areas of the brain. Preclinical investigations for the development of therapeutic vaccines against high grade gliomas, based on the use of DC loaded with a mixture of glioma-derived tumor have been carried out in rat as well as in mouse models, showing the capacity to generate a glioma-specific immune response. Mature DC loaded with autologous tumor lysate have been used also for the treatment of patients with recurrent malignant brain tumors; no major adverse events have been registered. Results about the use of immunotherapy for GBM patients are encouraging, but further studies are necessary to find out the most effective and safe combination of immunotherapy with radio- and chemotherapy after exeresis of the tumour mass.

Aim of the study. Primary objective of the study is to evaluate treatment tolerability and to get preliminary information about efficacy. Secondary objective is to evaluate the treatment effect on the immune response. Additional objective is to identify a possible correlation between methylation status of MGMT promoter and tumor response to treatment.

A two-stage Simon design ((2)Simon, 1989) will be considered for the study. Assuming as outcome measure the percentage of PFS12 patients and of clinical interest an increase to 42% (P1) of the historical control rate of 27% (P0) ((1)Stupp et al., 2005), the alternative hypothesis will be rejected at the end of the first stage if the PFS12 rate will be less than 8/24 treated patients (Fisher's exact test). In the second stage patients will be enrolled up to 76 overall. The null hypothesis will be rejected (a=0.05, b=0.2) if at least 27 subjects out of 76 are alive and progression free 12 months after the beginning of the treatment.

Background and significance. The therapeutic program will include radical surgical resection of the tumor, followed by radiotherapy (fractionated local field irradiation in daily fractions of 2 Gy given 5 days per week, Monday through Friday for 6 weeks, for a total of 60 Gy) plus temozolomide (TMZ) chemotherapy (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy). After a 4-week break, up to 6 cycles of maintenance TMZ (mTMZ) will be administered according to the standard 5-day (oral intake) schedule every 28 days. TMZ dose will be 150 mg per square meter for the first cycle and will be increased to 200 mg per square meter beginning with the second cycle, so long as there is no hematologic toxic effect. Immunotherapy will follow radiochemotherapy and will comprise 4 vaccinations every second week (injections I, II, III, IV), 2 further monthly vaccinations (injections V, VI) and a final vaccination (injection VII) 2 months after the sixth one. Injections I, V, VI and VII will contain 10 million tumor lysate-loaded DC, while the others will be of 5 million cells only. In correspondence to the third vaccine injection (week 13), mTMZ will start. On the basis of the patient clinical status, further vaccine boosts will be considered as appropriate addition at the standard vaccination cycle.

Phase I, 2-stage Simon design (Simon et al., 1997), single-centre, uncontrolled, open label, non-randomized study.

Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme

Phase I Clinical Trial Of Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme (DENDR1)

PFS12 is defined as the percentage of participants with PFS at 12 months from the date of surgery for newly diagnosed tumor to the first date of objectively determined progressive disease based on Response Assessment in Neuro-Oncology (RANO) criteria ((3)Wen et al JCO 2010) or death from any cause. It is assumed that PFS follows an exponential distribution. Estimation using Kaplan-Meier analysis.

Immune response will be monitored throughout study completion: during active treatment at least on vaccination-time points, and later an average of 2 months

Digestive System Diseases

Infections

Carcinoma

Carcinoma, Hepatocellular

Hepatitis A

Hepatitis

Hepatitis B

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Virus Diseases

Communicable Diseases

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Blood-Borne Infections

Hepadnaviridae Infections

DNA Virus Infections

Antirheumatic Agents

Lenvatinib

Cyclophosphamide

Chlorotrianisene

Immunosuppressive Agents

Sorafenib

Antineoplastic Agents, Alkylating

Alkylating Agents

Multiple Signals loaded Dendritic Cells Vaccine(MSDCV) immune therapy：one time every 4 weeks during 0 weeks to 20 weeks, about 5\*10\^7 cells per time, total 6 times; Hepatocellular Carcinoma Radical surgery therapy: one time at a good operation time before the first time of MSDCV immune therapy

Hepatocellular Carcinoma Radical surgery therapy: one time at a good operation time

Multiple Signals loaded Dendritic Cells Vaccine(MSDCV) immune therapy：one time every 4 weeks during 0 weeks to 20 weeks, about 5\*10\^7 cells per time, total 6 times; Transcatheter Hepatic Arterial Chemoembolization (TACE) therapy: the first time of TACE therapy must perform before the first time of MSDCV immune therapy， then perform when necessary according to subjects condition

Transcatheter Hepatic Arterial Chemoembolization (TACE) therapy: perform when necessary according to Subjects condition

Multiple Signals loaded Dendritic Cells Vaccine(MSDCV) immune therapy：one time every 4 weeks during 0 weeks to 20 weeks, about 5\*10\^7 cells per time, total 6 times; Targeted agents therapy: Sorafenib or Lenvatinib. For Sorafenib: 0.4g twice daily; for Lenvatinib: 12mg/8mg per day according to subjects condition

Targeted agents therapy: Sorafenib or Lenvatinib. For Sorafenib: 0.4g twice daily; for Lenvatinib: 12mg/8mg per day according to subjects condition

Intravenous drip，250mg/m\^2 per time，two days before each times of MSDCV therapy，total 6 times, in order to improve the immunosuppressive microenvironment of tumor，reduce CD4+CD25+FOXP3+regulatory T cells (Tregs）

one time every 4 weeks during 0 weeks to 20 weeks, about 5\*10\^7 cells per time, intravenous driptotal 6 times;

Multiple Signals loaded Dendritic Cells Vaccine

Yuehua HYuang, doctorate

Yifan Lian, doctorate

Li Liu, doctorate

Ming Shi, doctorate

Jiajun Zhang, doctorate

Yanhua Bi

Yuehua Huang, doctorate

The effect of anti-tumor treatment is not satisfying in HBV-related hepatocellular carcinoma (HBV-HCC) for reasons that HBV-HCC carries highly heterogeneous antigens to facilitate cancer cells escaping from immune surveillance and constructs an immunosuppressive microenvironment. Correspondingly, multiple signals loaded dendritic cells vaccine can efficiently present T cells with antigens of HCC sensitize their antitumor properties meanwhile low dose cyclophosphamide (CY) can effectively improve the microenvironment of immunity. Therefore, we put forward a new scientific therapy called "multiple signals loaded dendritic cells vaccine combined low dose of cyclophosphamide" combining with radical surgery or TACE or targeted agents for patients with hepatocellular carcinoma to prolong their survival time.

Detailed Description Patients who have good compliance complying with the inclusion criteria will be enrolled into our research. The 600 patients will be randomly assigned to experimental group and control group with the ratio of 1:1, control group will receive radical surgery or TACE or targeted agent treatment solely; another group (experimental group) after enrollment will radical surgery or TACE or targeted agent treatment in the first course. Then 20ml blood is taken for multiple signals loaded dendritic cells (MSDCV) culture (cell culture takes 7 days). Low dose (250mg/m\^2) CY treatment will be performed on patients two days before the MSDCV treatment. The MSDCV combined CY therapy will perform per 4 weeks, total 6 times. All patients are evaluated the safety and efficacy of treatment by monitoring their blood parameters, tumor indicators and imaging examinations at each visit.

"Cocktail" Therapy for Hepatitis B Related Hepatocellular Carcinoma

Precision Study on "Cocktail" Therapy to Improve the Efficacy of Hepatitis B-related Hepatocellular Carcinoma

The time from randomization until first documented progression or death from any cause，whichever came first

Measured for each subjects at each visits

The time from random assignment to death from any cause

Sun Yat-sen University

Nanfang Hospital, Southern Medical University

Yuehua Huang

Laboratory director of hepatology，Deputy director of infection

Neoplasm Metastasis

Colorectal Neoplasms

Neoplastic Processes

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Adjuvant treatment with dendritic cells vaccine after standard treatment

Vaccination with autologous dendritic cells loaded with autologous tumor antigens

Dendritic cells vaccine

Ignacio Melero, MD, PHD

Ignacio Melero, MD, PhD

Ruth Vera, MD

Ignacio Melero, MDPhD

In this randomized multicentric phase II study, patients with colorectal carcinoma with resectable hepatic metastasis will be randomized to treatment with dendritic cells or to observation, following conventional treatment with surgery and chemotherapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Recurrence Of Glioblastoma Multiforme	NCT04002804	Glioblastoma	Dendritic Cells...	18 Years - 70 Years	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Dendritic Cell Vaccine for Children and Adults With Sarcoma	NCT01803152	Sarcoma Soft Tissue Sar... Bone Sarcoma	Dendritic Cells... Lysate of Tumor Gemcitabine Imiquimod Leukapheresis	1 Year - 100 Years	University of Miami
Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Recurrence Of Glioblastoma Multiforme	NCT04002804	Glioblastoma	Dendritic Cells...	18 Years - 70 Years	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Newly Diagnosed Glioblastoma Multiforme	NCT04801147	Glioblastoma	Dendritic Cells...	18 Years - 70 Years	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
"Cocktail" Therapy for Hepatitis B Related Hepatocellular Carcinoma	NCT04317248	Hepatocellular ...	Cyclophosphamid... Multiple Signal...	18 Years - 70 Years	Third Affiliated Hospital, Sun Yat-Sen University
Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Recurrence Of Glioblastoma Multiforme	NCT04002804	Glioblastoma	Dendritic Cells...	18 Years - 70 Years	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study With Dendritic Cell Immunotherapy in Resected Hepatic Metastasis of Colorectal Carcinoma	NCT01348256	Colorectal Carc... Hepatic Metasta...	Dendritic cells...	18 Years -	Clinica Universidad de Navarra, Universidad de Navarra
"Cocktail" Therapy for Hepatitis B Related Hepatocellular Carcinoma	NCT04317248	Hepatocellular ...	Cyclophosphamid... Multiple Signal...	18 Years - 70 Years	Third Affiliated Hospital, Sun Yat-Sen University

Spots Global Cancer Trial Database for dendritic cells vaccine