Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03849105 | 131I-IPA and Concurrent XRT in Recurrent GBM | PHASE1 | COMPLETED | 10 | — | — | Apr 9, 2019 | Oct 31, 2022 | Apr 14, 2023 | 5 | Australia, Austria +1 |
Treatment-related adverse events according to NCI-CTCAE v 4.03 criteria will be captured and evaluated for each patient
Frequency of occurrence and severity of abnormal findings as measured by beats per minute
Frequency of occurrence and severity of abnormal findings as measured by mmHg
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
| Arm | Type | Description |
|---|---|---|
| Single administration of 131I-IPA (1f group) | EXPERIMENTAL | 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. |
| Three administrations of 131I-IPA (3f-parallel group) | EXPERIMENTAL | 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. |
| Three administrations of 131I-IPA (3f-sequential group) | EXPERIMENTAL | 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. |
| Dose escalation of fractionated dosing | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| 4-L-[131I]iodo-phenylalanine (131I-IPA) | RADIATION | 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 |
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, temoz...