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Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)

StatusRecruiting
PhasePhase 1/2
SponsorCerenome
Started2015-06-03
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 26, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2025-03-25
Study Status, Contacts/Locations v30
Primary completion date2025-01→2025-12
Completion date2025-01→2025-12
Study sitescontacts updated at 1 of 3 sites
2024-11-26
Study Status, Contacts/Locations v29
Study sites2→3
2024-11-07
Study Status, Contacts/Locations v28
Study sites3→2
2024-06-13
Study Status, Contacts/Locations v27
Re-verified, no change to tracked fields
2023-08-20
Study Status, Contacts/Locations v26
Study sitescontacts updated at 1 of 3 sites
Show 25 earlier versions
2023-08-10
Study Status, Contacts/Locations v25
Re-verified, no change to tracked fields
2022-12-07
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v24
Eligibility criteria+1,074 characters
Inclusion Criteria: At least 18 years of age. Ability to understand the purposes and risks of the study a [...] ent form approved by the investigator's IRB/Ethics Committee. Histologically confirmed Grade III/IV recurrent Glioma (following 2021 WHO CNS5 glioma nomenclature, e.g., Astrocytoma, IDH-mutant grade 3 or 4; Glioblastoma, IDH-wildtype grade 4). Progression by Response Assessment in Neuro-Oncology (RANO) criteria or other clinically accepted neurooncology evaluation, following standard treatment options with known survival benefit for any recurrence (Temozolomidee.g., Radiationsurgery, temozo [...] [...]
Secondary endpoints3 to 9 entries
Phase 1: Dose Distribution Phase 1: Response rate Phase 1: Survival Phase 1: Safety of single dose of treatment Phase 2: Safety and tolerability of 186RNL Phase 2: Objective response rate (ORR) Phase 2: Progression free survival at 6 months (PFS-6) Phase 2: Progression free survival (PFS) from the initiation of study to first documented progression Phase 2: Quality [...]
Primary endpoints1 to 2 entries
Phase 1: Maximum Tolerated Dose Phase 2: Overall Survival
Study description+593 characters
ThisThe Phase I portion of the clinical study evaluates a single dose of 186RNL (radionucl [...] f participants to be enrolled in the study is approximately 5521. The clinical study treatment will be administered, followi [...] al study physician. Participants will be followed for up to 1236 months after the clinical study drug is administered. The Phase II portion of the clinical study is a multicenter, single arm, prospective study utilizing a non-DLT dose obtained from the dose escalation portion of IND 116117, NIH-NCI Grant (22.3 mCi (total 186RNL activity) at a concentration of 2.5 mCi/mL and 8.8 mL to [...] [...]
2022-07-12
Study Status, Contacts/Locations v23
Re-verified, no change to tracked fields
2022-05-11
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v22
Eligibility criteria+77 characters
[...] cs Committee Histologically confirmed glioma Progression by Response Assessment in Neuro-Oncology (RANO) criteria following standard treatment options with known su [...] e being evaluated in the respective cohort (see 4.1 Design) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Life expectancy of at least 2 [...]
Study description+851 characters
This Phase I clinical study evaluates a single dose of 186RNL (radionuclide clinical study drug) administered through a convection enhanced delivery catheter (CED catheter) in participants with recurrent Glioma (GBM). The clinical study treatment consists of a single administered dose of 186RNL per [...]
Study sitescontacts updated at 1 of 3 sites
2021-11-03
Study Status, Contacts/Locations v21
Study sitescontacts updated at 1 of 3 sites
2020-12-09
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 3 sites
2020-12-09
Study Status, Contacts/Locations v19
Study sitesdetails revised at 1 of 3 sites
2020-12-02
Study Status, Contacts/Locations v18
Study sitesdetails revised at 1 of 3 sites
2020-11-17
Study Status, Contacts/Locations v17
Study sitescontacts updated at 2 of 3 sites
2020-07-09
Study Identification, Study Status, Conditions, Contacts/Locations v16
Study title+10 characters
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent Glioma (ReSPECT)
2020-07-08
Study Status, Contacts/Locations v15
Study sitesdetails revised at 1 of 3 sites
2020-06-29
Study Identification, Study Status, Sponsor/Collaborators, Study Description v14
Lead sponsorThe University of Texas Health Science Center at San Antonio→Plus Therapeutics
2020-04-09
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v13
Enrollment target30→55
Study sites1→3
Lead sponsorAndrew Brenner→The University of Texas Health Science Center at San Antonio
Eligibility criteria+74 characters
[...] m entry into the study through 6 months after the last dose For part 2: Bevacizumab naïve glioblastoma with no more than 1 recurrence Exclusion Criteria: The subject has evidence of acute intrac [...]
Secondary endpointsdetails revised at 1 of 3 entries
Collaborators+31 characters
National Cancer Institute (NCI)
2019-08-27
Study Identification, Study Status, Study Description, Conditions, Eligibility v12
Primary completion date2020-01→2025-01
Completion date2020-01→2025-01
Start date2015-03→2015-06-03
Eligibility criteria+438 characters
Inclusion Criteria: Planned stereotactic biopsy as standard of care (ie, for confirmation of disease progression) At least 18 years of age Ability to understand the purposes [...] nvestigator's IRB/Ethics Committee Histologically confirmed glioblastomaglioma Progression by RANO criteria following both standard combinedtreatment modalityoptions with known survival benefit (Temozolomide, Radiation, and Tumor Treating Fields [unless unwilling]) Patients who receive treatment with radiationantiepileptic andmedications temozolomidemust chemotherapy,have asa welltwo asweek anti-angiogenichistory therapyof [...]
Study description-2,169 characters
Rhenium-186 (186Re) (half-life 90 hours) is a reactor produced isotope with great potential for medical therapy. It is in the same chemical family as Technetium-99m (99mTc), a radioactive tracer that is the most commonly used isotope for diagnostic scintigraphic imaging in nuclear medicine. Like 99m [...]
Study title-6 characters
Maximum Tolerated Dose, Safety, and Efficacy of Rhenium Nanoliposomes in Recurrent GlioblastomaGlioma
2019-03-13
Study Status v11
Primary completion date2019-01→2020-01
Completion date2019-01→2020-01
2018-10-25
Study Status v10
Primary completion date2018-08→2019-01
Completion date2018-12→2019-01
2018-05-01
Study Status, Oversight, Arms and Interventions v9
InterventionsRhenium Liposome Treatment (Radiation)→Rhenium Liposome Treatment (Drug)
2017-10-12
Study Identification, Study Status, Arms and Interventions v8
Primary completion date2017-08→2018-08
Completion date2017-12→2018-12
2017-04-24
Study Status v7
Primary completion date2017-03→2017-08
2016-10-24
2 amendments v5-v6
2 re-verifications since 2015-12-23, no change to tracked fields
2015-03-13
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2015-03-10
Study Status, Contacts/Locations v3
Start date2014-12→2015-03
2014-09-16
Study Status, Arms and Interventions v2
Start date2014-03→2014-12
Study arms0→1
2014-02-11
Study Status v1
Primary completion date2016-10→2017-03
Start date2013-10→2014-03
2013-07-19
Original filing
Cerenome
5 trials monitored
See 1 trial at risk
Glioma
666 trials monitored
See 38 trials at risk
This is a multi-center, sequential cohort, open-label, volume and dose escalation study of the safety, tolerability, and distribution of 186RNL given by convection enhanced delivery to patients with recurrent or progressive malignant glioma after standard surgical, radiation, and/or chemotherapy treatment. The study uses a modified Fibonacci dose escalation, followed by an expansion at the maximum tolerated dose (MTD) to determine efficacy. The starting absorbed dose is 1mCi in a volume of 0.660mL.
Trial Details
NCT Number NCT01906385
Lead Sponsor Cerenome
Collaborators: National Cancer Institute (NCI)
Conditions Glioma
Enrollment 55 participants
Start Date 2015-06-03
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-03-26