TABLE 2.
Clinical trials (finished or ongoing) for potential use of cannabinoids for their antitumor effects.
| Cancer type | Type of study | Intervention/Treatment | Outcome measure | Result | Citation/Clinical trial # |
|---|---|---|---|---|---|
| Glioblastoma multiforme | Part 1- Phase 1b (open label) | Nabiximols oromucosal spray in combination with dose-dense Temozolamide | • Adverse events | • In Part 1 most adverse events were mild (CTCAE grade 1) or moderate (grade 2), the most frequently reported being fatigue, dizziness, headache, and vomiting | Twelves et al. (2021) |
| Part 2 randomized, double-blind, and placebo-controlled | • Progression Free Survival at 6 months (PFS) | • In Part 2, 33% of both nabiximols- and placebo-treated patients were progression-free at 6 months. Survival at 1 year was 83% for nabiximols- and 44% for placebo-treated patients | |||
| • Overall Survival (OS) | |||||
| Glioblastoma multiforme | Phase II, multi-center, double-blind, placebo-controlled, randomized trial (ARISTOCRAT) | Sativex in combination with Temozolamide | • Overall survival time (OS) | • Ongoing | NCT05629702 |
| • Progression-free survival time (PFS) | |||||
| • Health-related quality of life (HRQoL) | |||||
| • Adverse events | |||||
| Glioblastoma multiforme | Phase Ib, Open-label, Multicenter | THC+CBD 1:1 combination in the presence of temozolomide and radiotherapy | • Adverse events | • Ongoing | NCT03529448 |
| • THC-CBD Maximum tolerated dose | |||||
| • Tumor volume | |||||
| • Overall survival | |||||
| • Progression free survival | |||||
| Brain cancer | Phase 1 open label | Dexanabinol | • Dose Limiting Toxicity | • Generally, well tolerated | Juarez et al. (2021) |
| • Pharmacokinetics parameters of Dexanabinol | |||||
| • Adverse Events | • No objective tumor responses occurred | ||||
| • Progression Free Survival | |||||
| Glioblastoma multiforme | Phase II double-blind randomized clinical trial, single-centre | Whole plant extracts of cannabis based on a 1:1 and 4:1 ratio of THC: CBD in combination with standard of care | • Side effects | • Both cannabis product ratios were found to be well tolerated | Schloss et al. (2021) |
| • Blood safety markers | |||||
| • Dose response | • 11% had a reduction in disease, 34% had stable disease, 16% had slight tumor enhancement, 10% had progressive disease | ||||
| • Tumour growth | |||||
| Glioblastoma multiforme | Pilot phase I trial | Delta-9-THC | • Safety of intracranial THC administration | • No psychoactive side effects | Guzmán et al. (2006) |
| • Overall Survival | • No clinical benefit | ||||
| Solid tumors | Phase 2 open label | Cannabidiol | • Overall Response Rate | • Unknown | NCT02255292 |
| Glioblastoma Multiforme, Multiple Myeloma, and GI Malignancies | A Randomized, Double-Blind, Placebo-Controlled, Parallel, Multi-Cente | Cannabidiol (BRCX014) in combination with standard of care treatment | • Overall response rate | • Unknown | NCT03607643 |
| • Time to progression (TTP) | |||||
| • Progression-free survival (PFS) | |||||
| • Quality-of-life | |||||
| Acute leukemia and myelodysplastic syndrome | Phase 1, Phase 2 open label | Cannabidiol with standard GVHD prophylaxis (cyclosporine and methotrexate) | • Incidence rate of acute graft-versus-host disease after allogenic hematopoietic stem cell transplantation (GVHD) | • Cannabidiol prevents GVHD | Yeshurun et al. (2015) |