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Malignant GliomaPhase 1NCT00634231

A Phase I Study of AdV-tk + Prodrug Therapy in Combination With Radiation Therapy for Pediatric Brain Tumors

A Phase 1 study testing AdV-tk, valacyclovir and Radiation in people with Malignant Glioma and Recurrent Ependymoma, run by Candel Therapeutics, Inc. at 2 sites 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

This study will evaluate the administration of AdV-tk followed by valacyclovir in children with malignant glioma, including glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), as well as recurrent ependymomas in combination with radiation therapy. Read more about this study

Who is it for?
Ages 3 to 21 years
Conditions the study is for
Malignant Glioma, Recurrent Ependymoma
What is being tested?
AdV-tk, valacyclovir and Radiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
2 sitesUnited States
Study dates
Oct 2010to Jun 2021
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 3 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients must be 3 years of age or older
  • Patients must be planning to undergo standard of care treatment with surgery and radiation therapy.
  • Patients must have malignant glioma or recurrent ependymoma
  • Tumor must be accessible for injection and must not be located in the brainstem or deep midbrain
  • Performance Score: Karnofsky ≥60% if >10y/o, Lansky ≥60 if ≤10y/o
  • Bone Marrow Function: Patients must have adequate bone marrow function defined as a peripheral absolute neutrophil count ≥ 1000/µl, platelet count ≥ 100,000/µl (transfusion independent) and hemoglobin ≥ 8.0 gm/dL
Show all 11Show fewer
  • Renal Function: Patients must have serum creatinine ≤ 1.5 times upper limit of institutional normal for age and/or GFR ≥ 70 mL/min/1.73 m2.
  • Hepatic Function: Bilirubin ≤ 1.5 times institutional normal; SGPT (ALT) < 3 times institutional normal
  • Serum electrolyte values (sodium, potassium, magnesium, calcium) must be checked prior to enrollment and clinically significant abnormalities corrected prior to surgery/AdV-tk injection
  • Patients with seizure disorder may be enrolled if well controlled
  • Signed informed consent according to institutional guidelines must be obtained

Who cannot join

  • Prior or ongoing liver disease including known cirrhosis, hepatitis B or C infection but not to exclude patients with a distant history of resolved hepatitis A infection
  • Patients on immunosuppressive drugs (with exception of corticosteroid)
  • Known history of HIV or underlying immunodeficiency
  • Patients with acute infections (viral, bacterial or fungal infections requiring therapy)
  • Pregnant or breast-feeding patients. Female patients of childbearing age must have negative serum or urine pregnancy test within 1 week of beginning therapy
  • Other serious co-morbid illness or compromised organ function
  • No other investigational anti-tumor agents within 30 days prior to study entry or during active participation in the study (defined as from study entry until tumor progression)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Ann & Robert H. Lurie Children's Hospital of Chicago (Formerly Children's Memorial Hospital)

    Chicago, Illinois, 60611

Other trials in United States

About this study

This study will evaluate the administration of AdV-tk followed by valacyclovir in children with malignant glioma, including glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), as well as recurrent ependymomas in combination with radiation therapy. The primary objective is to determine if this approach is safe and can be effectively delivered without disturbing standard therapy.

Read the detailed description

This is an Open label, Phase I, dose escalation study. Patients will receive an injection of AdV-tk into the tumor or tumor bed during the surgical procedure followed by 14 days of anti-herpetic prodrug, valacyclovir, starting 1-3 days after vector injection. Standard radiotherapy will begin 3-7 days after AdV-tK injection. Standard chemotherapy may begin after completion of valacyclovir at the discretion of the treating physician and family. Two dose levels of AdV-tk will be evaluated with a fixed dose of valacyclovir.

Being tested
AdV-tk, valacyclovir, Radiation
Keywords
Malignant glioma, Glioblastoma multiforme, Anaplastic astrocytoma, Recurrent ependymoma, Gene therapy, Immunotherapy
Medical subject headings
Glioma, Ependymoma, Glioblastoma, Astrocytoma

What participants receive

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

  • AdV-tkBiological

  • valacyclovirDrug

    Also called Prodrug

  • RadiationRadiation

    Also called Radiation therapy

Study groups in NCT00634231
Study groupRoleWhat they receive
AdV-tkExperimentalAdV-tk + valacyclovir in combination with standard of care radiation
Receives: Biological: AdV-tk; Drug: valacyclovir; Radiation: Radiation

What is being measured

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

  1. Incidence of treatment emergent adverse events

    Measured: 2 months

Secondary outcomes (3)

  1. Overall survival

    Measured: 5 years

  2. Progression-free survival

    Measured: 5 years

  3. Objective tumor response

    Measured: 5 years

Timeline

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

  1. First posted12 Mar 2008 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2015
  4. Study completionJun 2021

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
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00634231
Sponsor's protocol ID
PeBrTK01
Status last verified
Aug 2023
First submitted
5 Mar 2008
Last updated
25 Aug 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Kieran MW, Goumnerova L, Manley P, Chi SN, Marcus KJ, Manzanera AG, Polanco MLS, Guzik BW, Aguilar-Cordova E, Diaz-Montero CM, DiPatri AJ, Tomita T, Lulla R, Greenspan L, Aguilar LK, Goldman S. Phase I study of gene-mediated cytotoxic immunotherapy with AdV-tk as adjuvant to surgery and radiation for pediatric malignant glioma and recurrent ependymoma. Neuro Oncol. 2019 Mar 18;21(4):537-546. doi: 10.1093/neuonc/noy202.

    PubMed 30883662

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AdV-tk, valacyclovir and Radiation in people with Malignant Glioma and Recurrent Ependymoma, run by Candel Therapeutics, Inc. at 2 sites 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 11 inclusion and 7 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 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Incidence of treatment emergent adverse events (time frame: 2 months). 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 NCT00634231, which also lists 1 linked publication.

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 25 Aug 2023.

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