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Malignant GliomaPhase 1NCT01808820

Dendritic Cell (DC) Vaccine for Malignant Glioma and Glioblastoma

A Phase 1 study testing Dendritic Cell Vaccine, Tumor Lysate and Imiquimod in people with Malignant Glioma and Glioblastoma Multiforme, run by Macarena De La Fuente, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 99 years
What is being tested?
Dendritic Cell Vaccine, Tumor Lysate and Imiquimod
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
21 Aug 2013to 16 Jul 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • Albumin > 2 g/dL
  • Subjects must agree to use adequate method of contraception or abstinence throughout and up to 4 weeks after the study treatment completion.
  • Karnofsky score 70 or higher or Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami

    Miami, Florida, 33136

Other trials in United States

About this study

Official title: Dendritic Cell Vaccine For Malignant Glioma and Glioblastoma Multiforme in Adult and Pediatric Subjects

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

Being tested
Dendritic Cell Vaccine, Tumor Lysate, Imiquimod, Leukapheresis
Keywords
HGG, Dendritic Cell Vaccine, DC Vaccine, Leukapheresis
Medical subject headings
Glioma, Glioblastoma, Astrocytoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dendritic Cell VaccineBiological

    Also called DC Vaccine

    Between 1.2 to 12 million DC per dose administered once a week via intradermal injection for 4 weeks.

  • Tumor LysateBiological

    Also called Lysate of Tumor, Lysate Boost

    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.

  • ImiquimodDrug

    Also called Aldara

    5% topical cream applied to vaccine site before and after administrations of DC vaccine or lysate

  • LeukapheresisProcedure or surgery

    Also called Pheresis

    Baseline, post-surgery blood draw via catheter to obtain peripheral blood mononuclear cells (PBMCs) from which Dendritic cells will be obtained.

Study groups in NCT01808820
Study groupRoleWhat they receive
Safety Pilot: DC Vaccine/LysateExperimentalParticipants 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).
Receives: Biological: Dendritic Cell Vaccine; Biological: Tumor Lysate; Drug: Imiquimod; Procedure: Leukapheresis
Expansion Cohort: DC Vaccine/LysateExperimentalParticipants 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).
Receives: Biological: Dendritic Cell Vaccine; Biological: Tumor Lysate; Drug: Imiquimod; Procedure: Leukapheresis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (6)

  1. Rate of Overall Survival (OS) in Study Participants

    Rate of overall survival in study participants receiving protocol therapy. Overall survival is defined as the time elapsed from the start of treatment until death. For surviving patients, follow-up will be censored at the date of last contact.

    Measured: Up to Week 80 (5 years post therapy)

  2. Rate of Progression-Free Survival (PFS) in Study Participants

    Rate of prolonged progression-free survival in study participants receiving protocol therapy. Progression-Free Survival (PFS) is defined as the time elapsed from the start of treatment to the date of documented progression or death, whichever comes first. For surviving patients without progression who begin alternative treatment, PFS will be censored at the last date of documented progression-free status prior to starting alternative treatment. Similarly, losses to follow up will be censored at the last date of documented progression-free status.

    Measured: Up to Week 80 (5 years post therapy)

  3. Change in MDSC Levels

    Immune response will be reported as the change in Myeloid Derived Suppressor Cell (MDSC) levels from blood samples

    Measured: Baseline, Up to Week 28

  4. Change in blood counts

    Measurement of immune response will be reported as the change in red and white blood counts from blood samples evaluated in million cells/microliter

    Measured: Baseline, Up to Week 28

  5. Comparison of clinical parameters associated with outcomes in study participants to patients on other DC/Imiquimod studies.

    To demonstrate if the clinical parameters associated with outcomes described for patients on other DC / imiquimod protocols hold for subjects treated on this study.

    Measured: Up to 5 years Post-Therapy

  6. Proportion of participants completing intervention.

    Proportion of participants able to receive all administrations of DC vaccine and those who are able to receive all administration of DC vaccine and lysate will be reported.

    Measured: Up to Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2013 (estimated)
  2. Study start21 Aug 2013
  3. Primary completion7 Nov 2018
  4. Study completion16 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01808820
Sponsor's protocol ID
20120750
Status last verified
Jul 2022
First submitted
6 Mar 2013
Last updated
20 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dendritic Cell Vaccine, Tumor Lysate and Imiquimod in people with Malignant Glioma and Glioblastoma Multiforme, run by Macarena De La Fuente, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Treatment-Related Adverse Events (time frame: Up to Week 32 (30 days after last dose of protocol therapy)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01808820.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.

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