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A Phase I Trial of Carboplatin Administered by Convection-Enhanced Delivery to Patients With Recurrent/Progressive Glioblastoma Multiforme

Phase 1
18 Years
Not Enrolling
Glioblastoma Multiforme

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Trial Information

A Phase I Trial of Carboplatin Administered by Convection-Enhanced Delivery to Patients With Recurrent/Progressive Glioblastoma Multiforme

Inclusion Criteria:

- 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

- Histologically confirmed glioblastoma multiforme. Patients with a previous history
of a lower grade gliomas are eligible if histology at relapse confirms glioblastoma

- 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

Exclusion Criteria:

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated infusion concentration

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Steven S Gill, MBChB MS FRCS

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Bristol NHS Trust


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

May 2011

Completion Date:

May 2015

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma multiforme
  • Carboplatin
  • Convection-enhanced delivery
  • Glioblastoma