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Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors

A Phase I Study of Dendritic Cell Vaccine Therapy With In Situ Maturation for Pediatric Brain Tumors

NCT01902771•Edward Ziga

Summary

DC vaccine manufactured and partially matured using our standard operating procedures, developed in collaboration with the HGG Immuno Group, then administered through imiquimod treated skin will be safe and feasible in children with refractory brain tumors. This will result in anti-tumor immunity that will prolong survival of subjects treated and results will be consistent with the outcomes found for subjects treated by HGG Immuno Group investigators. Study treatment will correlate with laboratory evidence of immune activation. Correlative studies will also reveal targets in the immune system which can be exploited to improve response for patients on successor trials.

Eligibility

Age

1 - 29 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age: ≥ 1 year and ≤ 29 years
•2. Relapse or progression of any central nervous system tumor initially diagnosed before the age of 21 years.
•3. Total or subtotal resection of tumor mass, confirmed by assessment by the neurosurgeon and by postoperative MRI scan within 72 hours after surgery. The post-operative assessment should demonstrate residual tumor less than or equal to 2 cm\^3 as judged by surgeon or on MRI the tumor should only show linear contrast enhancement at the border of the resection cavity or nodule less than 2 cm\^3.
•4. No radiotherapy and/or chemotherapy received for at least 1 month before first DC vaccination is to be administered.
•5. No treatment with corticosteroids or salicylates for at least 1 week before first vaccination.
•6. Life expectancy ≥ 3 months
•7. Written consent by patient or parent(s) (if patient is \< 18 years) on an institutional review board (IRB)-approved informed consent form prior to any study-specific evaluation. Assent is required from children as per University of Miami (UM) IRB guidelines. Subject must be capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent.
•8. Adequate organ function (to be measured at enrollment)
•* Absolute neutrophil count (ANC) ≥750/L
•* Lymphocytes ≥ 500/L
+8 more criteria

Exclusion Criteria

•1. Pregnancy.
•2. Breast feeding females.
•3. Any concomitant participation in other therapeutic trials.
•4. Virus serology positive for HIV (testing is not required in the absence of clinical suspicion).
•5. Documented immunodeficiency or autoimmune disease.
•6. Other active malignancies.
•7. Refusal to use adequate contraception for fertile patients (females and males) during the study and for 30 days after the last dose of study treatment.
•8. Any serious or uncontrolled medical or psychiatric condition that in the opinion of the investigator makes the patient not able to participate in the study.
•9. Application of gliadel wafers within the prior 4 months or a plan to place Gliadel wafers at the time of resection for tumor acquisition for study.

Locations (1)

University of Miami

Miami, Florida, United States

Key Dates

Start Date

September 3, 2013

Primary Completion Date

October 24, 2016

Completion Date

January 26, 2017

Last Updated

March 10, 2017

Enrollment

ACTUAL participants

Conditions

GliomaBrain CancerBrain TumorGlioblastoma MultiformeHigh Grade Glioma

Interventions

Dendritic Cell Vaccine

BIOLOGICAL

Tumor Lysate

BIOLOGICAL

Imiquimod

OTHER

Leukapheresis

PROCEDURE

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

View study

RECRUITINGPHASE1/PHASE2

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

NCT05099003

Malignant Glioma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma

The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery (IPSIMANON)

rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma