Phase I Study of Cellular Immunotherapy for Recurrent/Refractory Malignant Glioma Using Intratumoral Infusions of GRm13Z40-2, An Allogeneic CD8+ Cytolitic T-Cell Line Genetically Modified to Express the IL 13-Zetakine and HyTK and to be Resistant to Glucocorticoids, in Combination With Interleukin-2
Model scores of the 29,894 trials active now.
Model score 15% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 23% of the time (1,629 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2013-09-30, after 2010-05-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2013-09-30. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: braindialysisstageradiationeffective
Phrases that lowered it: participantparticipantsadulteffecttrial is -
Sponsor's past termination rate: 3.6% (lowers risk) · Sponsor's track record
-
Phase: 1 (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Disease area, cancer: Yes (raises risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 38 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 15.3% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, neurology: Yes (raises risk) · Disease area
-
Design: single group (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Keywords listed: 15 (raises risk) · Design
-
Drug's FAERS reports marked serious: 97.8% (raises risk) · Drug's FDA history
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Maximum age: 70 (lowers risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Sponsor's past trials: 28 (raises risk) · Sponsor's track record
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Collaborators: 0 (raises risk) · Design
-
Number of arms: 1 (raises risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 1 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 15 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 28 (typical: 32)
- Sponsor's past termination rate
- 3.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 38 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 405 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 39 (typical: 412.5)
- Drug's FAERS reports marked serious
- 97.8% (typical: 85.6%)
- Drug's FAERS reports with a death
- 15.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- cancer, neurology
- Drugs matched to FDA substances
- aldesleukin, human interleukin2
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- CAR T Cell Receptor Immunotherapy Targeting EGFRvIII for Patients With Malignant Gliomas Expressing EGFRvIII NCT01454596 · started 2012 · scored riskier than 99% of active trials completed
- Autologous CMV-Specific Cytotoxic T Cells and Temozolomide in Treating Patients With Glioblastoma NCT02661282 · started 2016 · scored riskier than 95% of active trials completed
- A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction with Poly-ICLC in Pediatric Gliomas NCT01130077 · started 2009 · scored riskier than 70% of active trials completed
- Zotiraciclib (TG02) Plus Dose-Dense or Metronomic Temozolomide Followed by Randomized Phase II Trial of Zotiraciclib (TG02) Plus Temozolomide Versus Temozolomide Alone in Adults With Recurrent Anaplastic Astrocytoma and Glioblastoma NCT02942264 · started 2016 · scored riskier than 99% of active trials terminated
- Brain Stem Gliomas Treated With Adoptive Cellular Therapy During Focal Radiotherapy Recovery Alone or With Dose-intensified Temozolomide (Phase I) NCT03396575 · started 2018 · scored riskier than 74% of active trials terminated
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.