Trials Sponsors Conditions Drugs Pricing

Conditions

Diffuse Intrinsic Pontine Glioma or Glioblastoma

Keywords

DC vaccine therapyDIPGGBMneoantigen

Outcome Measures

Primary Outcomes (2)

Safety of infusion of autologous immunomodulatory DC Vaccine is assessed by the NCI CTCAE V4.0 criteria.
Safety of the vaccine will be assessed by monitoring for adverse events (AEs) based on scheduled laboratory assessments.
2 years
Overall survival (OS) at 12 months (OS12).
OS12 will be the clinical efficacy primary endpoint. For subjects who are still alive at 12 months, OS12 will be censored at the last contact date. OS will be estimated using the Kaplan-Meier method.
12 months

Secondary Outcomes (5)

Treatment response rate of DIPG or GBM
6 months]
Overall survival Rate
1 year follow up
Progression-free survival rate
1 years
ELISPOT or antigen specific functional assays for evaluation of antigen specific immune response in patients
1 year
Magnetic resonance imaging for evaluation of disease progression and prognosis
1 years

Study Arms (1)

Immunomodulatory DC vaccine to target DIPG and GBM

EXPERIMENTAL

Patients will receive immune modulatory treatment consisting of cyclophosphamide (200 mg/m2) and bevacizumab (15 mg/kg), before and after DC vaccine injection, respectively.

Biological: Immunomodulatory DC vaccine to target DIPG and GBM

Interventions

Immunomodulatory DC vaccine to target DIPG and GBMBiological

This study will inject DC vaccine cells near lymphoid tissue close to the tumor. The patient will receive intravenous cyclophosphamide (200 mg/m2) or oral (cytoxan) before the vaccine, followed by DC vaccine and intravenous bevacizumab (15 mg/kg) the next day. The cells will be repeatedly infused every month for six consecutive months depending on the response and the condition of the patient. The amount of DC vaccine cells per injection is based on prior report at 5-10x106. An initial dose escalation scheme will be imposed.

Immunomodulatory DC vaccine to target DIPG and GBM

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age1 Year - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Abilities to understand and the willingness to provide written informed consent. Assent will be obtained when appropriate based on the subjects age;
Patients are ≥ 6 months and ≤ 80 years old;

Sponsors & Collaborators

Shenzhen Geno-Immune Medical Institute
Otherlead

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

MeSH Terms

Conditions

Diffuse Intrinsic Pontine GliomaGlioblastoma

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueBrain Stem NeoplasmsInfratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System Neoplasms

Study Officials

Lung-Ji Chang, PhD
Shenzhen Geno-Immune Medical Institute
PRINCIPAL INVESTIGATOR

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

+86 0755-86573763 c@szgimi.org

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 16, 2019

Study Start

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

Immune Modulatory DC Vaccine Against Brain Tumor

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (1)

Immunomodulatory DC vaccine to target DIPG and GBM

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (1)

Immunomodulatory DC vaccine to target DIPG and GBM

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations