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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
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 |
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 |
The IPAX-1 study is an open-label, single-arm, randomised, parallel-group, multi-centre dose-finding study to evaluate ascending radioactive dose levels of 131I-IPA, intravenously administered using different dose schedules (fractionations), concomitantly to 2nd line XRT (36 Gy, administered in 18 fractions of 2 Gy). Gross tumour volume will be determined using contrast-enhanced MRI and amino acid-based PET imaging (18F-FET or 11C-methionine). Patients will be included if they meet all of the following 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. Gross tumour volume (GTV) of up to 4.8 cm diameter, clinical target volume (CTV) 0.5 cm margin and planning target volume (PTV) less than or equal to 0.5 cm margin. 6. Male or female ≥18 years of age. 7. Karnofsky performance status (KPS) ≥70. Life expectancy of at least 16 weeks. 8. Haematological, liver and renal function test results as follows:
Experimental: Single administration of 131I-IPA (1f group)
Study participants with GBM receive a single administration of 4-L-[131I]iodo-phenylalanine (131I-IPA), followed by 18 cycles of external radiotherapy, each cycle being of 2 Gy.
Experimental: Three administrations of 131I-IPA (3f-parallel group)
Study participants will be administered in 2GBq in 3 fractions corresponding to ⅓ full dose activity (0.67 GBq for the 2.0 GBq dose level). The 1st fraction of 131I-IPA will be administered as above, 1- 3 days prior to 1st XRT. The 2nd and 3rd 131I-IPA fractions will be administered after 5-9 XRT fractions (subject to investigator's discretion and day of IMP administration) following the previous 131I-IPA fraction. The remainder of XRT fractions will be given following the 3rd 131I-IPA fraction.
Experimental: Three administrations of 131I-IPA (3f-sequential group)
Study participants will be administered in 2GBq in 3 fractions corresponding to ⅓ full dose activity (0.67 GBq for the 2.0 GBq dose level). The 1st fraction of 131I-IPA will be administered as above 1- 3 days prior to 1st XRT. The 2nd 131I-IPA fraction will be administered after all 18 XRT fractions have been completed, and the 3rd 131I-IPA fraction will be administered 1 week after the 2nd 131I-IPA fraction.
Experimental: Dose escalation of fractionated dosing
Dose escalation will be made in steps of 2.0 GBq, i.e. 4.0 (3*1.33 GBq), 6.0 GBq (3*2.0 GBq), up to 8.0 GBq (3*2.67 GBq) until the maximum tolerated dose (MTD) is reached, using cohorts of N=3 patients.
Radiation: - 4-L-[131I]iodo-phenylalanine (131I-IPA)
Study participants will receive by intravenous infusion an escalating activity of 4-L-[131I]iodo-phenylalanine (131I-IPA). Additional therapy is received in the form of externally administered radiotherapy
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.
Status
Recruiting
Address
Lake Macquarie Private Hospital
Gateshead, New South Wales, 2290
Status
Recruiting
Address
Kepler University Clinic
Linz, , 4020
Status
Recruiting
Address
Medical University of Vienna
Vienna, , 1090
Status
Recruiting
Address
The Netherlands Cancer Institute
Amsterdam, , 1066
Status
Recruiting
Address
UMC Utrecht Cancer Center
Utrecht, , 3508