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Glioblastoma MultiformePhase 1NCT01317212

Dose-Escalation Study of Carboplatin Administration Into the Brain for Glioblastoma Multiforme

A Phase 1 study testing Peritumoural carboplatin administration. in people with Glioblastoma Multiforme, run by North Bristol NHS Trust at 1 site in United Kingdom.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

High-grade gliomas are the commonest primary malignant brain tumours in adults, affecting approximately 5000 people per year in the UK. Standard treatment comprises a combination of surgery, radiotherapy and chemotherapy; however this condition remains incurable and the average survival is approximately 18 months from… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma Multiforme
What is being tested?
Peritumoural carboplatin administration.
Type of treatment
Injection or infusion
How many people
0 participants
Where
1 siteUnited Kingdom
Study dates
May 2015to May 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Department of Neurosurgery

    Bristol, Bristol, BS16 1LE

Other trials in United Kingdom

About this study

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

High-grade gliomas are the commonest primary malignant brain tumours in adults, affecting approximately 5000 people per year in the UK. Standard treatment comprises a combination of surgery, radiotherapy and chemotherapy; however this condition remains incurable and the average survival is approximately 18 months from diagnosis. There are a number of reasons for this. Firstly these tumours are highly invasive and involve important areas of brain making it impossible to remove them surgically or cure them with radiotherapy. In the majority of cases the tumour recurs within 2 to 3cm of the original site of tumour removal. Secondly, due to the presence of a barrier between the bloodstream and the brain, when drugs designed to kill tumour cells (chemotherapy) are given intravenously or orally, they frequently do not reach the tumour at a sufficient dose to have a beneficial effect. As the chemotherapy dose has to be very high for a sufficient dose to reach the tumour, drug-related side-effects are common.

Laboratory studies demonstrate that glioma tumour cells are sensitive to a number of different chemotherapies, including carboplatin. When given intravenously however, carboplatin does not reach a sufficient concentration in the tumour to have a beneficial effect. However, studies have shown that carboplatin can be infused directly into the brain at a concentration that is highly toxic to tumour cells, but not to normal brain tissue. Using very small tubes implanted around the tumour, the investigators are able to infuse carboplatin reliably and repeatedly into the area where tumours typical recur. In this study, the investigators intend to evaluate the safety of this approach and determine the optimal dose of carboplatin to administer. It is hoped that this study will also provide evidence of improved survival for patients with high-grade glioma.

Being tested
Peritumoural carboplatin administration.
Keywords
Glioblastoma multiforme, Carboplatin, Convection-enhanced delivery
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peritumoural carboplatin administration.Drug

    Peritumoural carboplatin administration by convection-enhanced delivery (CED) through 4 implanted intracranial catheters. Infusions conducted weekly for 4 consecutive weeks.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated infusion concentration

    Measured: 2 years

  2. Complications/side-effects/tolerability/toxicity (As defined by Eastern Cooperative Oncology Group criteria) of treatment.

    Measured: 2 years.

Secondary outcomes (6)

  1. Serial quality of life measurements at 3-month intervals.

    Measured: 2 years.

  2. Progression-free survival (PFS) based on serial MRI scans at 3-month intervals.

    Measured: 2 years.

  3. Overall survival.

    Measured: 2 years.

  4. Relationship between catheter location and visible carboplatin distribution based on MRI.

    Measured: 2 years.

  5. Relationship between carboplatin distribution, PFS and overall survival.

    Measured: 2 years.

  6. Serum carboplatin pharmacokinetics during/after intracranial infusions.

    Measured: 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2011 (estimated)
  2. Study startMay 2015
  3. Primary completionMay 2017 (estimated)
  4. Study completionMay 2018 (estimated)

Why it stopped: Sufficient funding could not be secured for the study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01317212
Sponsor's protocol ID
2467
Other IDs
2010-023454-37
Status last verified
Apr 2015
First submitted
16 Mar 2011
Last updated
17 Apr 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Peritumoural carboplatin administration. in people with Glioblastoma Multiforme, run by North Bristol NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated infusion concentration (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01317212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.

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