Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
North Bristol NHS Trust
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18 years old or over
Male or female
World Health Organisation performance status 0-2
Life expectancy greater than 3 months
Capacity to give informed consent
Progressive and/or recurrent disease confirmed by MRI
Progressive disease, defined as 25% or greater increase in contrast-enhanced tumour volume on T1-weighted MRI
Supratentorial disease
Disease confined to a single quadrant of brain
It must be feasible to achieve sufficient carboplatin distribution in the peritumoural tissue as defined by the principal investigator and/or trial coordinator. Feasibility may be determined through the use of appropriate software that uses diffusion imaging and fluid dynamics mathematical modelling to predict infusate distribution
Recurrent disease following conventional treatment, including surgery (biopsy or debulking), radiotherapy and chemotherapy (temozolomide)
More than 30 days since prior chemotherapy (42 days for nitrosureas or mitomycin)
More than 90 days since radiotherapy or radiosurgery
More than 7 days since tumour debulking or other neurosurgery
More than 30 days since prior investigational agents or participation in another clinical research trial
Platelet count \> or = 100,000/mm3
Absolute neutrophil count \> or = 1000mm3
Total bilirubin no greater than 1.5 x upper limit of normal (except patients with Gilbert's syndrome)
AST and ALT \< or = to 2 times upper limit of normal
PT and APTT no greater than control
Creatinine clearance \> 50ml/min using Cockcroft Formula
Fertile patients must agree to use effective contraception during and for 2 months after study treatment
Negative pregnancy test if appropriate
You may not be if
Clinical evidence of raised intracranial pressure.
Concurrent medical condition that would preclude general anaesthesia.
Severe acute infection.
Pregnancy or breast feeding.
Documented allergy to carboplatin or cisplatin.
Prior participation in a trial of biological therapy (e.g. monoclonal antibodies, gene therapy, oncolytic viral therapy, immunotoxin therapy).
Prior local chemotherapy, including administration of biodegradable polymer wafers containing carmustine.
Prior enrolment in this study.
Concurrent anticancer drugs.
Concurrent investigational therapies.
Infratentorial or intraventricular tumour visible on MRI.
Clareo Health | Dose-Escalation Study of Carboplatin Administration Into the Brain for Glioblastoma Multiforme
