TheranosticTrials.org
Telix Pharmaceuticals

Clinical Trial · NCT03849105

131I-IPA and Concurrent XRT in Recurrent GBM

Overview

A multi-centre, open-label, single-arm, dose-finding phase I/II study to evaluate safety, tolerability, dosing schedule, and preliminary efficacy of carrier-added 4-L-\[131I\]iodo-phenylalanine (131I-IPA), administered as single or repetitive injections in patients with recurrent glioblastoma multiforme (GBM), concomitantly to 2nd line external radiation therapy (XRT) - IPAX-1

Sponsor

Telix Pharmaceuticals

Phase

Phase 1/2

Contacts

Josef Pichler, MD (PRINCIPAL_INVESTIGATOR)

Tatjana Traub-Weidinger (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03849105

Drug / Compound

FET

Isotope(s):
Target(s):
  • Amino Acid Transport
Ligand Class: Small Molecules

IPA

Isotope(s):
Target(s):
  • Amino Acid Transport
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Haemoglobin \>80 g/L
  • Amino acid-based molecular imaging (preferably 18F-FET-PETor 11C-methionine, as institutionally established) indicating pathologically increased amino acid uptake inside or in the vicinity of the tumour, clearly discernible from background activity.
  • Haematological, liver and renal function test results as follows:
  • ALT, ALP, AST: ≤5 times upper international limit of normal (UILN)
  • Karnofsky performance status ≥70. Life expectancy of at least 16 weeks.
  • Bilirubin ≤3 times UILN
  • Interval since end of 1st line XRT ≥6 months
  • Previously confirmed histological diagnosis of GBM, with current clinical or imaging evidence for first recurrence according to modified RANO criteria (2017). History of GBM standard therapy (debulking surgery, followed by radio-chemotherapy (50-60 Gy in 2 Gy fractions, temozolomide)
  • WBC: \>3\*109/L
  • Current indication for repeat radiation therapy as discussed at the multidisciplinary neuro-oncological tumour board meeting, planned as standard fractionated dose schedule (18\*2 Gy)
  • PLT \>100\*109/L

Exclusion

  • Administration of another investigational medicinal product within 90 days prior to screening
  • Prior treatment with bevacizumab
  • Ongoing toxicity \> grade 2 NCI-CTC (version 4.03) from previous standard or investigational therapies
  • Localisation of tumour related to brain stem or axis, unless sufficient reserve capacity (e.g. remnant resection cavity, marked atrophy) to accommodate possible post-procedural tissue reactions, or pre-therapeutic consent for emergency trepanation
  • Prior treatment with brachytherapy
  • Multifocal distant recurrence, defined as tumour lesion outside the primary XRT field, as evidenced by amino acid-based PET imaging
  • In pre-menopausal women: Pregnant as evidenced by a positive pregnancy test, or breast-feeding
  • Primary XRT dose \< 60 Gy

Patient Education

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Publications

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