Dendritic Cell 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 patients with high grade glioma. This
will result in anti-tumor immunity that will prolong survival of subjects treated. Study
treatment will correlate with laboratory evidence of immune activation.
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
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) or
- 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. Corticosteroid therapy should be rapidly weaned within 1-2 weeks after
surgery
- 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
- ECOG performance status of 0 or 1 or Karnofsky > or = 70
- 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.
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
- Mandatory treatment with corticosteroids or salicylates in the week prior to first
vaccination
- 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.
- 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