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131I-IPA + XRT as Treatment for Patients With Glioblastoma Multiforme

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. 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) 2. Interval since end of 1st line XRT ≥6 months 3. 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. 4. 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) 5. Male or female ≥18 years of age. 6. Karnofsky performance status ≥70. Life expectancy of at least 16 weeks. 7. Haematological, liver and renal function test results as follows:
  • - WBC: >3*109/L - Haemoglobin >80 g/L - PLT >100*109/L - ALT, ALP, AST: ≤5 times upper international limit of normal (UILN) - Bilirubin ≤3 times UILN - Serum creatinine: within normal limits or <120 μmol/L for patients aged 60 years or older - Urine protein dipstick: no protein 8.
Female patients surgically sterile or postmenopausal for at least 2 years. Participants of generative potential agreeing to use effective contraception during the period of therapy and 6 months after the end of study. 9. Written informed consent

Exclusion Criteria:

1. Primary XRT dose < 60 Gy 2. Doses to organs at risk defined by Yasar and Tugrul (2005) exceeded or reached by prior radiation therapy; e.g. cumulative total dose on the optical chiasm >54 Gy for 2 Gy/fraction, alphas/beta=2 3. Multifocal distant recurrence, defined as tumour lesion outside the primary XRT field, as evidenced by amino acid-based PET imaging 4. Prior treatment with brachytherapy 5. Prior treatment with bevacizumab 6. Baseline steroid requirement , exceeding physiologic replacement doses ( <1.5 mg dexamethasone or equivalent per day) 7. History or evidence of delayed-type hypersensitivity (DTH)-dependent chronic infection (e.g. tuberculosis, systemic fungal or parasitic infection), potentially exacerbating under systemic corticoid therapy 8. 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 9. Haemostaseologic conditions, precluding catheterisation or invasive procedures 10. Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product 11. Known impairment of liver or kidney function or known liver or kidney disease, such as hepatitis, cirrhosis, renal failure 12. Known human immunodeficiency virus (HIV) positive serology or chronically active hepatitis B or C 13. Ongoing toxicity > grade 2 NCI-CTC (version 4.03) from previous standard or investigational therapies 14. Administration of another investigational medicinal product within 90 days prior to screening 15. Expected non-compliance with longer-term admission at isolated nuclear medicine ward 16. In pre-menopausal women: Pregnant as evidenced by a positive pregnancy test, or breast-feeding 17. Patients with known phenylketonuria

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03849105
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Telix International Pty Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Josef Pichler, MDTatjana Traub-Weidinger
Principal Investigator Affiliation Kepler University Clinic, Linz, AustriaMedical University of Vienna
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Austria, Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Additional Details

Primary objective To assess the safety and tolerability of intravenous 131I-IPA administered concomitantly to 2nd line XRT in recurrent GBM Secondary objectives 1. To assess the maximum tolerated dose (MTD) of 131I -IPA administered concomitantly to 2nd line XRT in recurrent GBM 2. To evaluate the feasibility of a fractionated administration of 131I-IPA 3. To evaluate the radiation absorbed dose to tumour from 131I-IPA 4. To confirm biodistribution and absorbed doses to whole body and organs from 131I-IPA 5. To explore the antineoplastic effect of 131I-IPA + XRT combination therapy 6. To explore the occurrence and frequency of pseudo-progression (PP) in response to 131I-IPA + XRT combination therapy 7. To explore the cognitive function before, during and after therapy

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

UMC Utrecht Cancer Center, Utrecht, Netherlands

Status

Recruiting

Address

UMC Utrecht Cancer Center

Utrecht, , 3508

Site Contact

Arthur J.A.T. Braat, MD

global-clinicaltrials@telixpharma.com

+61 3 9093 3808

The Netherlands Cancer Institute, Amsterdam, Netherlands

Status

Recruiting

Address

The Netherlands Cancer Institute

Amsterdam, , 1066

Medical University of Vienna, Vienna, Austria

Status

Recruiting

Address

Medical University of Vienna

Vienna, , 1090

Site Contact

Tatjana Traub-Weidinger, MD

global-clinicaltrials@telixpharma.com

+61 3 9093 3808

Kepler University Clinic, Linz, Austria

Status

Recruiting

Address

Kepler University Clinic

Linz, , 4020

Site Contact

Josef Pichler, MD

josef.pichler@kepleruniklinikum.at

+435768087

Lake Macquarie Private Hospital, Gateshead, New South Wales, Australia

Status

Recruiting

Address

Lake Macquarie Private Hospital

Gateshead, New South Wales, 2290