Clinical trial NCT01812616 (phase 1/phase 2, status: completed)
Conditions: cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: sativex, placebo
SMILES: [H][C@@]12C=C(C)CC[C@@]1([H])C(C)(C)OC1=C2C(O)=CC(CCCCC)=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Patient is willing and able to give informed consent for participation in the study.

          -  Patient is aged 18 years or above.

          -  Histopathologically confirmed diagnosis of grade four Glioblastoma Multiforme as per
             World Health Organisation classification.

          -  Evidence of patients first tumour progression (as determined by Revised Assessment in
             Neuro-Oncology) following radiation and first line chemotherapy with Temozolomide.

          -  If taking steroids, then the dose must be stable or decreasing.

          -  Karnofsky performance scale of 60% or greater.

          -  Patient is able (in the investigators opinion) and willing to comply with all study
             requirements.

          -  Patient is willing for his or her name to be notified to the responsible authorities
             for participation in this study, as applicable in individual countries.

          -  Patient is willing to allow his or her primary care practitioner and consultant, if
             appropriate, to be notified of participation in the study.

        Exclusion Criteria:

          -  Patients with Glioblastoma Multiforme secondary to low-grade glioma or anaplastic
             glioma (anaplastic astrocytoma or anaplastic oligodendroglioma).

          -  Patients currently receiving treatment for recurrent Glioblastoma Multiforme.

          -  Less than a four week interval since prior chemotherapy.

          -  Less than a 12 week interval since prior radiotherapy unless there is either: a)
             histopathology confirmation of recurrent tumour, or b) new enhancement on Magnetic
             Resonance Imaging outside of the radiotherapy treatment field.

          -  Presence of extra-cranial metastatic disease.

          -  Any surgery, including intracranial biopsy (not including minor diagnostic procedures
             such as lymph node biopsy) within two weeks of baseline disease assessments; or not
             fully recovered from any side effects of previous procedures.

          -  Any history of a different malignancy unless the patient has remained disease-free for
             at least three years and are at low risk for recurrence of that malignancy (cervical
             cancer in situ, and basal cell or squamous cell carcinoma of the skin are exempt from
             this criterion if treatment has occurred).

          -  Have previously received first line chemotherapy other than Temozolomide.

          -  Presents with Leptomeningeal dissemination.

          -  Have previously received stereotactic radiotherapy, convection enhanced delivery or
             brachytherapy (as gliosis/scarring from these modalities may limit delivery).

          -  The patient is currently using or has used cannabis or cannabinoid based medications
             within 30 days of study entry and is unwilling to abstain for the duration of the
             study.

          -  Any known or suspected history of a substance abuse/dependence disorder, current heavy
             alcohol consumption (>60g of pure alcohol per day for men, >40 g of pure alcohol per
             day for women), current use of an illicit drug or current non prescribed use of any
             prescription drug.

          -  Any history or immediate family history of schizophrenia, other psychotic illness,
             severe personality disorder or other significant psychiatric disorder other than
             depression associated with their underlying condition.

          -  Has experienced myocardial infarction or clinically significant dysfunction within the
             last 12 months or has a cardiac disorder that, in the opinion of the investigator
             would put the patient at risk of clinically significant arrhythmia or myocardial
             infarction.

          -  Has grade 3 or above toxicity by Common Terminology Criteria for Adverse Events
             criteria.

          -  Female patients of child bearing potential and male patients whose partner is of child
             bearing potential, unless willing to ensure that they or their partner use effective
             contraception, for example, oral contraception, double barrier, intra-uterine device,
             during the study and for three months thereafter (however a male condom should not be
             used in conjunction with a female condom).

          -  Female patients who are pregnant, lactating or planning pregnancy during the course of
             the study and for three months thereafter.

          -  Patient who have received an Investigational Medicinal Product within the four weeks
             prior to the screening visit.

          -  Any other significant disease or disorder which, in the opinion of the investigator,
             may either put the patient at risk because of participation in the study, or may
             influence the result of the study, or the patient's ability to participate in the
             study.

          -  Travel outside the country of residence planned during the study.

          -  Patients previously enrolled into this study and received either Investigational
             Medicinal Product or Dose-Intense Temozolomide.

          -  Any known or suspected hypersensitivity to cannabinoids or any of the excipients of
             the Investigational Medicinal Product.

          -  Any known allergy to or other intolerability to Temozolomide.

          -  Following a physical examination, the patient has any abnormalities that, in the
             opinion of the investigator would prevent the patient from safe participation in the
             study.

          -  Unwilling to abstain from donation of blood during the study.