Reverse swing-M, phase 1 study of repurposing mebendazole in recurrent high-grade glioma
An Indian phase 1 trial gave a worm medicine to 11 people with recurrent glioblastoma alongside chemotherapy or re-irradiation, found the dose they could tolerate, and saw anaemia and nausea as the most common side effects.
Overview
Eleven patients with recurrent glioblastoma were enrolled in an accelerated titration design: arm A1 added mebendazole to re-irradiation with concurrent temozolomide, arm B1 to lomustine and arm C1 to temozolomide alone (Reverse swing-M phase 1 2020). The maximum tolerated dose was not reached in arms A1 and C1, giving a recommended phase 2 dose of 1600 mg three times a day, while with lomustine it was 1600 mg three times a day and the recommended dose 800 mg three times a day; the most common adverse events were anaemia in 9 patients, nausea in 7 and fatigue in 6 (Reverse swing-M phase 1 2020).
- Recommended phase 2 dose 1600 mg three times a day with temozolomide or chemoradiation; 800 mg three times a day with lomustine.
- Anaemia 82 percent, nausea 64 percent, fatigue 55 percent.
This is what legitimate repurposing looks like: a registered dose-finding trial that reports its toxicities. It says nothing yet about whether mebendazole helps glioblastoma.
- Phase 1 with 11 patients; no efficacy endpoint.
Similar pages
not linked directly; found by shared links- Key paperA phase 2a clinical study on the safety and efficacy of individualized dosed mebendazole in patients with advanced gastrointestinal cancer
Shares Mebendazole, Systematic drug repurposing.
- TermDose-limiting toxicity (DLT)
Shares Recommended phase 2 dose (RP2D), Dose-escalation designs (3+3, BOIN, dose-expansion).
- TrialA Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme
Shares Lomustine (CCNU), Glioma & glioblastoma.
- PersonMichael Weller
Shares Lomustine (CCNU), Temozolomide, Glioma & glioblastoma.
- TrialCODEL
Shares Lomustine (CCNU), Temozolomide, Glioma & glioblastoma.
- TermMaximum tolerated dose (MTD)
Shares Recommended phase 2 dose (RP2D), Dose-escalation designs (3+3, BOIN, dose-expansion).
- TrialA Study of NanO2™ Combined With Radiation and Temozolomide in Patients With Newly Diagnosed GBM
Shares Temozolomide, Glioma & glioblastoma.
- TrialA Phase 2b Clinical Study With a Combination Immunotherapy in Newly Diagnosed Patients With Glioblastoma
Shares Temozolomide, Glioma & glioblastoma.