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Dendritic Cell Vaccine For Malignant Glioma and Glioblastoma Multiforme in Adult and Pediatric Subjects

Phase 1
13 Years
Not Enrolling
Malignant Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma, High Grade Glioma

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Trial Information

Dendritic Cell Vaccine For Malignant Glioma and Glioblastoma Multiforme in Adult and Pediatric Subjects

Inclusion Criteria:

- Age: >= 13 years and < 100 years

- Relapse of high grade glioma (anaplastic astrocytoma WHO grade III or glioblastoma
multiforme WHO grade IV), histologically proven at first stage of disease
(radiological evidence for recurrence suffices)

- Relapse of glioma, which was grade II at initial diagnosis, but which is grade III
or IV at relapse based on radiological or pathological criteria

- 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. Corticosteriod therapy should be rapidly weaned within 1-2 weeks after

- 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

- 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

- ECOG performance status of 0 or 1

- 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 above 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

- Mandatory treatment with corticosteroids or salicylates prior to first

- 3.3.8 Other active malignancies

- Patients with unresectable tumors, for instance pontine gliomas, are excluded.

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Subjects Experiencing Adverse Events

Outcome Description:

To demonstrate that dendritic cell vaccine loaded with tumor lysate is feasible and safe in pediatric and adult subjects with relapsed high grade glioma or glioblastoma multiforme treated at the University of Miami. This will be done in the same manner as that of our HGG Immuno collaborators and will use imiquimod topically as the final step in maturing the vaccine product. The number of subjects experiencing adverse events will be characterized by type, grade and attribution to treatment as well as by time of onset in relation to the day of Dendritic Cell vaccination. We will report the number and percent of unacceptable adverse events among subjects

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

John Goldberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2013

Completion Date:

Related Keywords:

  • Malignant Glioma
  • Glioblastoma Multiforme
  • Anaplastic Astrocytoma
  • High Grade Glioma
  • Malignant Glioma
  • Glioblastoma Multiforme
  • Anaplastic Astrocytoma
  • High Grade Glioma
  • HGG
  • Dendritic Cell Vaccine
  • DC Vaccine
  • Leukapheresis
  • Astrocytoma
  • Glioblastoma
  • Glioma



University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136