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Oncology clinic said these 4 common drugs are proven good and safe for off label use on brain tumors adjunctive to standard cancer treatment
- Thread starter ginfreely
- Start date
What is the COC Protocol?
The COC Protocol is a combination treatment regimen comprised of licensed medications, specifically designed by Care Oncology for adjunctive use alongside a patient’s usual treatments (i.e. standard-of-care).The four medications included in the COC Protocol regimen are: metformin, a very common anti-diabetes drug; atorvastatin, a type of statin used to manage cardiovascular conditions; doxycycline, a type of antibiotic often used to treat chronic infections like acne; and mebendazole, a medicine commonly used to treat parasite infections in children and adults.
We chose these four medications from thousands of potential candidates specifically because they fit our predetermined selection criteria. These criteria include solid evidence of effectiveness against cancer, a coherent mechanism of action, and importantly, a good safety profile. These three central tenets have shaped our approach from the very beginning.
https://careoncology.com/the-coc-pr...s included in,medicine commonly used to treat
Initial results suggest that patients who attended our clinic and took the COC Protocol as part of their usual care were much more likely to survive at least 2 years (64.0% of patients in our study survived at least 2 years, compared to 27-29% for patients included in previously published studies), and tended to have longer survival times overall than would usually be expected for patients with this type of cancer (patients survived an average of 27 months in our study, compared to 15-16 months in earlier studies)(Agrawal et al., 2019).
These results are extremely promising, but they are also still preliminary. We don’t yet know exactly how the COC Protocol may have impacted survival times for example, or how other factors such as certain patient characteristics may have also influenced these results. But this first, initial evidence is certainly encouraging, and it suggests to us that we are heading in the right direction. Our next planned stage is to conduct a larger, well-designed study. You can find out more about future METRICS plans by looking online or contacting the clinic.
These results are extremely promising, but they are also still preliminary. We don’t yet know exactly how the COC Protocol may have impacted survival times for example, or how other factors such as certain patient characteristics may have also influenced these results. But this first, initial evidence is certainly encouraging, and it suggests to us that we are heading in the right direction. Our next planned stage is to conduct a larger, well-designed study. You can find out more about future METRICS plans by looking online or contacting the clinic.
Ongoing clinical research
Table 1 summarizes current ongoing or recently completed clinical trials investigating individual metabolically targeted off-label COC Protocol medications in the treatment of brain tumors, including gliomas of all types, glioblastoma, and childhood brain tumors such as medulloblastoma.It is notable that whereas most studies are testing just one or two of these medications in combination with standard treatments, Care Oncology’s own METRICS study (NCT02201381) is currently the only study to investigate the tolerability and effectiveness of a combination of four off-label metabolic treatments (i.e. atorvastatin, mebendazole, metformin, and doxycycline) alongside standard treatments in glioma and other cancers.
Table 1: Clinical trials for COC Protocol medications in brain tumors
| NCT number | Cancer type | Summary | Completion date |
| Metformin | |||
| NCT02496741 | Glioma Cholangiocarcinoma Chondrosarcoma | Phase 1/2 trial in approx. 20 adults investigating tolerability and effectiveness of metformin and chloroquine in IDH1/2 positive solid tumors | Dec 2016; Results NA |
| NCT02149459 | Brain neoplasms | Phase 1 trial in approx. 18 adults investigating safety and effectiveness of treatment of recurrent brain tumors using metabolic manipulation (metformin and low carb diet) combined with radiotherapy | Jul 2018; Results NA |
| NCT02040376 | Brain tumor treated with cranial or cranial-spinal radiation | A Phase 3 trial in approx. 24 children with medulloblastoma treated with cranial-spinal radiation investigating effectiveness of added metformin for brain repair | Mar 2018 Results NA |
| NCT02780024 | Glioblastoma multiforme | A Phase 2 trial in approx. 50 adults investigating the effectiveness and tolerability of metformin, neo-adjuvant temozolomide and hypo-accelerated radiotherapy followed by adjuvant temozolomide | Dec 2021 |
| NCT03243851 | Recurrent or refractory glioblastoma | A Phase 2 trial in approx. 108 adults investigating safety and effectiveness of low dose temozolomide plus metformin or placebo | Dec 2019 |
| NCT03151772 | Glioblastoma | An early Phase 1 trial in approx. 40 patients investigating the bioavailability (activity in the body) of disulfiram and metformin in glioblastoma | Mar 2021 |
| NCT01430351 | Glioblastoma multiforme | A Phase I/II trial in approx. 144 adults investigating the safety and effectiveness of temozolomide plus various combinations of memantine, mefloquine, or metformin for post-radiation therapy of glioblastoma multiforme | Sep 2019 |
| NCT01528046 | Relapsed or refractory solid tumors and primary brain tumors | A Phase 1 trial in approx. 25 children investigating safety and effectiveness of metformin in combination with vincristine, irinotecan and temozolomide | Dec 2020 |
| Statins | |||
| NCT02115074 | Glioma | A Phase 1 trial in approx. 21 children investigating the safety and effectiveness of fluvastatin and celebrex in low-grade and high grade optico-chiasmatic gliomas | Oct 2022 |
| NCT02029573 | Glioblastoma multiforme | A Phase 2 trial in approx. 36 adults investigating the efficacy and safety of atorvastatin in combination with radiotherapy and temozolomide in glioblastoma | Dec 2016 Results NA |
| NCT02104193 | Brain metastases | A Phase 2 trial in approx. 50 adults investigating the efficacy and safety of simvastatin with radiation therapy of brain metastases | Dec 2015; Trial terminated, results NA |
| Mebendazole | |||
| NCT01729260 | Newly diagnosed high-grade glioma | A Phase 1 trial in approx. 24 adults investigating the tolerability of mebendazole in glioma patients receiving temozolomide | Sep 2020 |
| NCT01837862 | Childhood glioma | A Phase I/2 trial in approx. 36 children investigating the safety and effectiveness of mebendazole in combination with vincristine, carboplatin and temozolomide or bevacizumab and irinotecan for the treatment of childhood gliomas | Apr 2020 |
| NCT02644291 | Recurrent/progressive childhood brain tumors | Phase I study in approx. 21 children investigating the safety and effectiveness of mebendazole therapy |
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