Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
Conditions
Glioma - Brain Cancer - Brain Tumor - Glioblastoma Multiforme - High Grade Glioma
Conditions: official terms
Brain Neoplasms - Glioblastoma - Glioma
Conditions: Keywords
Dendritic Cell Vaccine, DCV, Pediatric, Brain Tumor, In Situ, Lysate, Tumor Lysate, Glioblastoma Multiforme, GBM, Pheresis, Leukapheresis, High Grade Glioma, HGG
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Dendritic Cell Vaccine Type: Biological
Name: Tumor Lysate Type: Biological
Name: Imiquimod Type: Other
Name: Punch Biopsy of the Skin Type: Procedure
Name: Leukapheresis Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 30 Years
Minimum Age: 1 Year
Gender: Both
Criteria: Inclusion Criteria:

- Age: > or equal to 1 year and < 30 years

- Relapse or progression of any central nervous system tumor initially diagnosed before the age of 21 years.

- 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 cm3 as judged by surgeon and on MRI the tumor should only show linear contrast enhancement at the border of the resection cavity or nodule less than 2 cm3.

- No radiotherapy and/or chemotherapy received for at least 1 month before first DC vaccination is to be administered

- No treatment with corticosteroids or salicylates for at least 1 week before first vaccination.

- Life expectancy > 3 months

- 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 UM IRB guidelines.

- Adequate organ function (to be measured at enrollment):

- Absolute neutrophil count (ANC) >750/L

- Lymphocytes > 500/L

- Platelets > 75,000/L

- Hemoglobin > 9 g/dL

- AST/ALT < 2.5 X ULN; if liver metastases, < 5 X ULN

- Serum Creatinine < 1.5 X ULN

- Total Bilirubin < 3 X ULN

- Albumin > 2 g/dL

- Subjects must agree to use adequate method of contraception or abstinence throughout and up to 4 weeks after the study treatment completion.

- Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent.

- Karnofsky score greater than or equal to 70 or ECOG status of 0 or 1.

Exclusion Criteria:

- Pregnancy

- Breast feeding females

- Any concomitant participation in other therapeutic trials

- Virus serology positive for HIV (testing is not required in the absence of clinical suspicion)

- Documented immunodeficiency

- Documented autoimmune disease

- Other active malignancies

- 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.

- 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.

- 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
Location
University of Miami
Miami, Florida, United States
Status: Recruiting
Contact: Edward Ziga, MD - e.ziga@med.miami.edu
Start Date
July 2013
Sponsors
Edward Ziga
Source
University of Miami
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page