CompletedPhase 1

Dendritic Cell (DC) Vaccine for Malignant Glioma and Glioblastoma

United States20 participantsStarted 2013-08-21

Plain-language 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.

Who can participate

Age range13 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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)

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 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.

What they're measuring

Number of Participants with Treatment-Related Adverse Events

Timeframe: Up to Week 32 (30 days after last dose of protocol therapy)

Trial details

NCT IDNCT01808820

SponsorMacarena De La Fuente, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11-07

View on ClinicalTrials.gov More Malignant Glioma trials