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

Conditions:Cancer, Brain Cancer, Brain Cancer, Brain Cancer
Therapuetic Areas:Oncology
Age Range:1 - 30
Start Date:July 2013

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

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.

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

- 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

- 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
We found this trial at
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
Miami, FL
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