Dendritic Cell (DC) Vaccine for Malignant Glioma and Glioblastoma
Dendritic Cell Vaccine For Malignant Glioma and Glioblastoma Multiforme in Adult and Pediatric Subjects
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2013
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2013
CompletedFirst Posted
Study publicly available on registry
March 11, 2013
CompletedStudy Start
First participant enrolled
August 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2022
CompletedJuly 20, 2022
July 1, 2022
5.2 years
March 6, 2013
July 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Treatment-Related Adverse Events
Adverse Events will be evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.0 by treating physician
Up to Week 32 (30 days after last dose of protocol therapy)
Secondary Outcomes (6)
Rate of Overall Survival (OS) in Study Participants
Up to Week 80 (5 years post therapy)
Rate of Progression-Free Survival (PFS) in Study Participants
Up to Week 80 (5 years post therapy)
Change in MDSC Levels
Baseline, Up to Week 28
Change in blood counts
Baseline, Up to Week 28
Comparison of clinical parameters associated with outcomes in study participants to patients on other DC/Imiquimod studies.
Up to 5 years Post-Therapy
- +1 more secondary outcomes
Study Arms (2)
Safety Pilot: DC Vaccine/Lysate
EXPERIMENTALParticipants in this group will undergo leukapheresis after standard of care surgical tumor resection. Leukapheresis will be used to obtain peripheral blood mononuclear cells (PBMC) from which the dendritic cells (DC) will be obtained. Retrieved DC will be used as a vaccine once weekly on Weeks 1-4 within 3 weeks from end of leukapheresis. Participants will also receive Imiquimod, which will be applied one evening prior to DC dose for 8 hours then for 8 hours each of the next two evenings. Enrollment of participants in the Pilot group will be staggered until the second participant has no treatment limiting toxicities. For the first five subjects to be enrolled in the pilot, the administration of DC to each subject will be delayed until the prior subject has received the second administration of DC. Participants will also receive Lysate of tumor administered every 4 weeks + 3 days on Weeks 8, 12, 16 and 28 (+ / - 3 days).
Expansion Cohort: DC Vaccine/Lysate
EXPERIMENTALParticipants in this group will undergo leukapheresis within after standard of care surgical tumor resection. Leukapheresis will be used to obtain peripheral blood mononuclear cells (PBMC) from which the dendritic cells (DC) will be obtained. Retrieved DC will be used as a vaccine once weekly on Weeks 1-4 within 3 weeks from end of pheresis. Participants will also receive Imiquimod, which will be applied one evening prior to DC dose for 8 hours then for 8 hours each of the next two evenings. Participants will also receive Lysate of tumor administered every 4 weeks + 3 days on Weeks 8, 12, 16 and 28 (+ / - 3 days).
Interventions
Between 1.2 to 12 million DC per dose administered once a week via intradermal injection for 4 weeks.
Post-DC Vaccine therapy. Up to 1.5 mg of Lysate of tumor per dose administered via intradermal injection at intervals defined by study protocol.
5% topical cream applied to vaccine site before and after administrations of DC vaccine or lysate
Baseline, post-surgery blood draw via catheter to obtain peripheral blood mononuclear cells (PBMCs) from which Dendritic cells will be obtained.
Eligibility Criteria
You may qualify if:
- Age: ≥ 13 years and ≤ 99 years.
- (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.
- 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.
- 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 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.
- 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
- +3 more criteria
You may not qualify if:
- 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 or 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Macarena De La Fuente, MD
University of Miami
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor of Clinical
Study Record Dates
First Submitted
March 6, 2013
First Posted
March 11, 2013
Study Start
August 21, 2013
Primary Completion
November 7, 2018
Study Completion
July 16, 2022
Last Updated
July 20, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share