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