Clinical trial NCT01808820: Dendritic Cell (DC) Vaccine for Malignant Glioma and Glioblastoma
Official title: Dendritic Cell Vaccine For Malignant Glioma and Glioblastoma Multiforme in Adult and Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Glioma
Glioblastoma Multiforme
Anaplastic Astrocytoma
High Grade Glioma
Keywords: HGG
Dendritic Cell Vaccine
DC Vaccine
Leukapheresis
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2013-03-11
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate an investigational vaccine using patent-derived dendritic cells (DC) to treat malignant glioma or glioblastoma.


Eligibility criteria: Inclusion Criteria:

1. Age: ≥ 13 years and ≤ 99 years.
2. (2a) Relapse of high grade glioma (anaplastic astrocytoma World Health Organization (WHO) grade III or glioblastoma multiforme WHO grade IV), histologically proven at first stage of disease (radiological evidence for recurrence suffices); OR (2b) 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.
3. 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 cm\^3 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 cm\^3.
4. No radiotherapy and/or chemotherapy received for at least 1 month before first DC vaccination is to be administered
5. 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.
6. Life expectancy \> 3 months.
7. 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 University of Miami (UM) IRB guidelines. Subject must be capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent.
8. Adequate organ function (to be measured at enrollment)

   * Absolute neutrophil count (ANC) ≥ 0.75 10\*3/µl
   * Lymphocytes ≥ 0.5 10\*3/µl
   * Platelets ≥ 75 10\*3/µl
   * Hemoglobin ≥ 9 g/dL
   * Aspartate transaminase (AST)/Alanine transaminase (ALT) ≤ 2.5 X upper limit of normal (ULN); if liver metastases, ≤ 5 X ULN
   * Serum Creatinine ≤ 1.5 X ULN
   * Total Bilirubin ≤ 3 X ULN
   * Albumin \> 2 g/dL
9. Subjects must agree to use adequate method of contraception or abstinence throughout and up to 4 weeks after the study treatment completion.
10. Karnofsky score 70 or higher or Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.

Exclusion Criteria:

1. Pregnancy.
2. Breast feeding females.
3. Any concomitant participation in other therapeutic trials.
4. Virus serology positive for HIV (testing is not required in the absence of clinical suspicion).
5. Documented immunodeficiency or autoimmune disease.
6. Mandatory treatment with corticosteroids or salicylates in the week prior to first vaccination.
7. Other active malignancies.
8. Patients with unresectable tumors, for instance pontine gliomas, are excluded.
9. 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.
10. 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.
11. 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.

Primary outcomes:
measure: Number of Participants with Treatment-Related Adverse Events
timeFrame: Up to Week 32 (30 days after last dose of protocol therapy)
Secondary outcomes:
measure: Rate of Overall Survival (OS) in Study Participants
timeFrame: Up to Week 80 (5 years post therapy)
measure: Rate of Progression-Free Survival (PFS) in Study Participants
timeFrame: Up to Week 80 (5 years post therapy)
measure: Change in MDSC Levels
timeFrame: Baseline, Up to Week 28
measure: Change in blood counts
timeFrame: Baseline, Up to Week 28
measure: Comparison of clinical parameters associated with outcomes in study participants to patients on other DC/Imiquimod studies.
timeFrame: Up to 5 years Post-Therapy
measure: Proportion of participants completing intervention.
timeFrame: Up to Week 28
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Macarena De La Fuente, MD
role: PRINCIPAL_INVESTIGATOR
References: