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      A pilot clinical study of Δ 9-tetrahydrocannabinol in patients with recurrent glioblastoma multiforme

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          Abstract

          Δ 9-Tetrahydrocannabinol (THC) and other cannabinoids inhibit tumour growth and angiogenesis in animal models, so their potential application as antitumoral drugs has been suggested. However, the antitumoral effect of cannabinoids has never been tested in humans. Here we report the first clinical study aimed at assessing cannabinoid antitumoral action, specifically a pilot phase I trial in which nine patients with recurrent glioblastoma multiforme were administered THC intratumoraly. The patients had previously failed standard therapy (surgery and radiotherapy) and had clear evidence of tumour progression. The primary end point of the study was to determine the safety of intracranial THC administration. We also evaluated THC action on the length of survival and various tumour-cell parameters. A dose escalation regimen for THC administration was assessed. Cannabinoid delivery was safe and could be achieved without overt psychoactive effects. Median survival of the cohort from the beginning of cannabinoid administration was 24 weeks (95% confidence interval: 15–33). Δ 9-Tetrahydrocannabinol inhibited tumour-cell proliferation in vitro and decreased tumour-cell Ki67 immunostaining when administered to two patients. The fair safety profile of THC, together with its possible antiproliferative action on tumour cells reported here and in other studies, may set the basis for future trials aimed at evaluating the potential antitumoral activity of cannabinoids.

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          Most cited references 31

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          The molecular logic of endocannabinoid signalling.

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            Isolation, Structure, and Partial Synthesis of an Active Constituent of Hashish

             Y GAONI,  R Mechoulam (1964)
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              Chemotherapy in adult high-grade glioma: a systematic review and meta-analysis of individual patient data from 12 randomised trials.

              Trials on the effect of systemic chemotherapy on survival and recurrence in adults with high-grade glioma have had inconclusive results. We undertook a systematic review and meta-analysis to assess the effects of such treatment on survival and recurrence. We did a systematic review and meta-analysis using updated data on individual patients from all available randomised trials that compared radiotherapy alone with radiotherapy plus chemotherapy. Data for 3004 patients from 12 randomised controlled trials were included (11 published and one unpublished). Overall, the results showed significant prolongation of survival associated with chemotherapy, with a hazard ratio of 0.85 (95% CI 0.78-0.91, p<0.0001) or a 15% relative decrease in the risk of death. This effect is equivalent to an absolute increase in 1-year survival of 6% (95% CI 3-9) from 40% to 46% and a 2-month increase in median survival time (1-3). There was no evidence that the effect of chemotherapy differed in any group of patients defined by age, sex, histology, performance status, or extent of resection. This small but clear improvement in survival from chemotherapy encourages further study of drug treatment of these tumours.
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                Author and article information

                Journal
                Br J Cancer
                British Journal of Cancer
                0007-0920
                1532-1827
                11 July 2006
                17 July 2006
                : 95
                : 2
                : 197-203
                Affiliations
                [1 ]simpleDepartment of Biochemistry and Molecular Biology I, School of Biology, Complutense University , Madrid 28040, Spain
                [2 ]simpleDepartment of Neurosurgery, Hospital Universitario de Canarias, La Laguna , Tenerife 38320, Spain
                Author notes
                [* ]Author for correspondence: mgp@ 123456bbm1.ucm.es
                [* ]Author for correspondence: lgferia@ 123456yahoo.es
                Article
                6603236
                10.1038/sj.bjc.6603236
                2360617
                16804518
                Copyright 2006, Cancer Research UK
                Categories
                Translational Therapeutics

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