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Newly Diagnosed Pediatric Pontine GliomaPhase 1NCT01130077

A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction with Poly-ICLC in Pediatric Gliomas

A Phase 1 study testing HLA-A2 restricted glioma antigen peptides vaccine and Poly-ICLC in people with Newly Diagnosed Pediatric Pontine Glioma and Newly Diagnosed Pediatric High Grade Glioma, run by James Felker 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 overall objective of this pilot study is to collect immunological and safety data following administration of vaccinations with HLA-A2. This data will be used to decide whether a larger study of clinical efficacy is warranted. Read more about this study

Who is it for?
Ages 12 months to 21 years
What is being tested?
HLA-A2 restricted glioma antigen peptides vaccine and Poly-ICLC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Feb 2009to 1 Nov 2024
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 12 months to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Tumor Types - Tumor type/location:
  • Stratum A: Newly diagnosed diffuse intrinsic pontine gliomas OR any biopsy proven high-grade glioma involving the brainstem. Patients may not have received chemotherapy during or after radiation. (Note: Stratum A is closed to accrual.)
  • Stratum B: Newly diagnosed, non-brainstem high-grade glioma Patients may not have received chemotherapy during or after radiation. (Note: Stratum B is open to accrual.)
  • Stratum C: Unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Patients may not have received radiation to the index lesion within 1 year of enrollment. (Note: Stratum C is closed to accrual.)
  • Stratum D: Non-brainstem high-grade gliomas that have recurred following treatment. (Note: Stratum D is closed to accrual.)
  • Stratum E: Newly diagnosed high-grade gliomas or brain stem gliomas who received chemotherapy during radiation therapy. Patients may not have received chemotherapy after radiation therapy was completed. (Note: Stratum E is closed to accrual.)
Show all 22Show fewer
  • Stratum F: Newly diagnosed high-grade gliomas with metastatic disease within the CNS requiring craniospinal radiation therapy. Patients may or may not have received chemotherapy during radiation, but cannot have received chemotherapy after radiation therapy was completed. (Note: Stratum F is closed to accrual.)
  • Eligible histologies include glioblastoma (GBM), anaplastic astrocytoma (AA) or gliosarcoma. Patients with any oligodendroglioma component are NOT eligible.
  • HLA-A2 positive based on flow cytometry.
  • Patients in Stratum A B and E must have received standard involved field radiation therapy [RT] defined as fractionated external beam radiotherapy with total doses between 5000-6000 cGy. Patients in these strata must be registered within 4-12 weeks of completing RT.
  • Patients in Stratum F must have received craniospinal radiation.
  • Patients must be clinically stable and off or on low-dose (no more than 0.1 mg/kg/day, max 4 mg/day Dexamethasone) corticosteroid for at least one week prior to study registration.
  • All patients must sign an IRB-approved informed consent document
  • Patients must be ≥ 12 months and <22 years of age at the time of study registration.
  • Patients must have a performance status of ≥ to 60.
  • Patients must have life expectancy of at least 8 weeks.
  • Documented negative serum βHCG for female patients who are post-menarchal. Pregnant females will not be included in the study. Males and females must agree to use effective birth control methods during the course of vaccination.
  • Patients must be free of systemic infection.
  • Patients with adequate organ function as measured by: Bone marrow: ANC > 1,000/µl; Platelets > 100,000/µl (transfusion independent); absolute lymphocyte count of ≥500/uL; Hemoglobin >8 g/dl (may be transfused). Hepatic: bilirubin ≤ 1.5x institutional normal for age; SGPT (ALT) < 3x institutional normal.
  • Renal: Serum creatinine based on age or Creatinine clearance or radioisotope GFR >70 ml/min/ml/min/1.73 m²
  • Patients on Strata C and D must have recovered from the toxic effects of prior therapy: at least 3 weeks form the last dose of standard cytotoxic chemotherapy or myelosuppressive biological therapy and at least 1 week from the last dose of non-myelosuppressive biologic therapy.
  • No overt cardiac, gastrointestinal, pulmonary or psychiatric disease.

Who cannot join

  • Patients living outside of North America are not eligible.
  • Presence of metastatic disease for patients in Stratum A, B, D and E. Patients with low grade gliomas (stratum C) may have tumor spread within the CNS.
  • Patients in Stratum F must have tumor spread within the CNS.
  • Patients enrolled in Strata A and B may not have received any prior chemotherapy or anti-glioma therapy of any type other than radiation therapy. Patients enrolled on stratum C must have received at least two prior chemotherapy or biologic therapy regimens and may not have received radiation to the index lesion within 1 year of enrollment. Patients on Strata A, B, E, and F can not have received chemotherapy after radiation therapy was completed.
  • Concurrent treatment or medications (must be off for at least 1 week) including:
  • Interferon (e.g. Intron-A®)
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  • Allergy desensitization injections
  • Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
  • Interleukins (e.g. Proleukin®)
  • Any investigational therapeutic medication
  • Patients must not have a history of, or currently active autoimmune disorders.
  • Use of immunosuppressives within four weeks prior to study entry. Dexamethasone, or other corticosteroid medications, if used in the peri-operative period and/or during radiotherapy, must be tapered (no more than 0.1 mg/kg/day, max 4 mg/day dexamethasone) for at least one week before study registration. Topical corticosteroids are acceptable.
  • Patients with known addiction to alcohol or illicit drugs.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Hospital of Pittsburgh of UPMC

    Pittsburgh, Pennsylvania, 15224

Other trials in United States

About this study

Official title: A Pilot Study to Evaluate the Effects of Vaccinations with HLA-A2-Restricted Glioma Antigen-Peptides with Poly-ICLC for Children with Newly Diagnosed Malignant Brain Stem Gliomas, Non-Brainstem High-Grade Gliomas, Recurrent Low-Grade Gliomas or Recurrent High Grade Gliomas

The overall objective of this pilot study is to collect immunological and safety data following administration of vaccinations with HLA-A2. This data will be used to decide whether a larger study of clinical efficacy is warranted.

Being tested
HLA-A2 restricted glioma antigen peptides vaccine, Poly-ICLC
Keywords
Pediatric glioma, Vaccine therapy

What participants receive

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

  • HLA-A2 restricted glioma antigen peptides vaccineBiological

    Also called BB13624

    Vaccine given every 3 weeks

  • Poly-ICLCBiological

    Vaccine given every 3 weeks

Study groups in NCT01130077
Study groupRoleWhat they receive
HLA Restricted glioma antigen peptides plus Poly ICLCExperimentalAll subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks)
Receives: Biological: HLA-A2 restricted glioma antigen peptides vaccine; Biological: Poly-ICLC

What is being measured

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

  1. Safety: Tolerability during the first two vaccine courses as defined in the protocol.

    Tolerability during the first two vaccine courses as defined in the protocol.

    Measured: 6 weeks

Secondary outcomes (1)

  1. Glioma-associated antigen-specific T-cell response

    Glioma-associated antigen-specific T-cell response: determined by IFN-gamma-enzyme linked immune spot (ELISPOT) and tetramer assays

    Measured: Monitoring will continue as long as subject remains on study.

Timeline

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

  1. First posted25 May 2010 (estimated)
  2. Study startFeb 2009
  3. Primary completion1 Nov 2024
  4. Study completion1 Nov 2024

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
Not applicable
Intervention model
Single group
Model description
Pilot study to assess tolerability of this vaccine regimen in different strata of children with high risk gliomas
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01130077
Sponsor's protocol ID
STUDY19040319
Other IDs
PRO08030085
Status last verified
Oct 2023
First submitted
24 May 2010
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pollack IF, Jakacki RI, Butterfield LH, Hamilton RL, Panigrahy A, Potter DM, Connelly AK, Dibridge SA, Whiteside TL, Okada H. Antigen-specific immune responses and clinical outcome after vaccination with glioma-associated antigen peptides and polyinosinic-polycytidylic acid stabilized by lysine and carboxymethylcellulose in children with newly diagnosed malignant brainstem and nonbrainstem gliomas. J Clin Oncol. 2014 Jul 1;32(19):2050-8. doi: 10.1200/JCO.2013.54.0526. Epub 2014 Jun 2.

    PubMed 24888813

  • Robison NJ, Kieran MW. Diffuse intrinsic pontine glioma: a reassessment. J Neurooncol. 2014 Aug;119(1):7-15. doi: 10.1007/s11060-014-1448-8. Epub 2014 May 3.

    PubMed 24792486

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HLA-A2 restricted glioma antigen peptides vaccine and Poly-ICLC in people with Newly Diagnosed Pediatric Pontine Glioma and Newly Diagnosed Pediatric High Grade Glioma, run by James Felker 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 22 inclusion and 13 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 6 Dec 2024. 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?

Safety: Tolerability during the first two vaccine courses as defined in the protocol. (time frame: 6 weeks). 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 NCT01130077, which also lists 2 linked publications.

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 6 Dec 2024.

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