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Phase I/II study of tumor-infiltrating lymphocyte (TIL) infusion and low-dose interleukin-2 (IL-2) in patients with advanced malignant pleural mesothelioma (MPM).

2015· article· en· W2589956845 on OpenAlexaff
Mark Doherty, Natasha B. Leighl, Ronald Feld, Penelope Ann Bradbury, Lisa Wang, Jessica Nie, Pei Hua Yen, Michael Pniak, Linh T. Nguyen, Marcus O. Butler, Marc de Perrot

Bibliographic record

VenueJournal of Clinical Oncology · 2015
Typearticle
Languageen
FieldMedicine
TopicOccupational and environmental lung diseases
Canadian institutionsUniversity of TorontoOntario Institute for Cancer ResearchPrincess Margaret Cancer Centre
Fundersnot available
KeywordsMedicineRegimenTumor-infiltrating lymphocytesOncologyInternal medicineInterim analysisChemotherapy regimenMelanomaChemotherapySurgeryImmunotherapyUrologyCancerClinical trialCancer research

Abstract

fetched live from OpenAlex

TPS7586 Background: MPM is a disease with poor outcomes, and only modest benefits from existing systemic therapies. Preclinical studies have shown that MPM often contains populations of TILs, and that these can be expanded ex vivo. Therapy using autologous TIL infusions and IL-2 following lymphodepleting chemotherapy has been successfully used in advanced melanoma. The therapeutic potential for TILs in MPM has not yet been explored. Methods: This is a single arm, phase I/II study to evaluate the feasibility, safety, and efficacy of TIL therapy for advanced MPM at the Princess Margaret Cancer Centre. Eligibility criteria include: advanced MPM, suitable surgical candidate for TIL harvesting from tumor, ECOG performance status 0-1, adequate organ function, and successful expansion of TILs. TILs are harvested from fresh tumor tissue, evaluated for suitability, and expanded ex-vivo. Patients are treated with a lymphodepleting chemotherapy regimen containing cyclophosphamide (60mg/m2 x 2 days) and fludarabine (25mg/m2 x 5 days), followed by infusion of expanded TILs. This is followed by low-dose IL-2 therapy (125000 IU/kg/day subcutaneously) for 2 weeks. The treatment protocol is adapted from that used in melanoma TIL studies, and no dose exploration is planned. The primary objective is determining the feasibility and safety of the regimen. Efficacy as measured by objective response rate (modified RECIST) is a secondary objective. The planned sample size is 10 patients. An informal interim analysis will be performed after 6 patients have been treated to review treatment toxicities and feasibility, given the lack of previous experience with this treatment in MPM. Correlative studies include analysis of peripheral blood mononuclear cells and assessment of persistence of infused TILs. Patients are currently being screened for TIL expansion at the Princess Margaret Cancer Centre.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.001
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Non-randomized trial · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.003
Threshold uncertainty score0.011

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0020.001
Meta-epidemiology (narrow)0.0020.001
Meta-epidemiology (broad)0.0020.001
Bibliometrics0.0010.000
Science and technology studies0.0010.001
Scholarly communication0.0010.001
Open science0.0010.000
Research integrity0.0020.003
Insufficient payload (model declined to judge)0.0030.001

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.054
GPT teacher head0.405
Teacher spread0.351 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNon-randomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations4
Published2015
Admission routes1
Has abstractyes

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