A Pilot Study of Cetuximab Radiolabelled with Gallium-68, Lutetium-177 or Rhenium-188 as a Novel Radioimmunotherapy for Advanced Head and Neck Cancer: A New Adjunct to Multi-modality Treatment.

For patients with advanced head and neck squamous cell carcinoma, does Cetuximab Radiolabelled with Gallium-68, Lutetium-177 or Rhenium-188 exhibit tumour uptake relative to background sufficiently to enable targeted radioimmunotherapy?

Status

Not yet recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000491662

Acronym

The ReCHANCE Study

Enrollment

Registered

2014-05-12

Start date

2014-05-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is evaluating whether radiolabelled Cetuximab exhibits tumour uptake sufficiently to enable targeted radioimmunotherapy in patients with advanced head and neck cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced head and neck squamous cell carcinoma, without option for further surgery or radiotherapy. Study details: All participants in this study will undergo a precursor imaging study with gallium-68-cetuximab. If appropriate they will be offered salvage radioimmunotherapy with newly developed Rhenium-188-Cetuximab or Lutetium-177-Cetuximab using the tumour-targeting ability of Cetuximab to deliver internal radiation to the tumour. Follow up assessments will comprise standard-of-care imaging and blood testing. Given a favourable response, repeat radioimmunotherapy may be contemplated for subsequent relapse with either of the aforementioned beta emitting radionuclides.

Interventions

A theranostic micro dosing trial of gallium-68-DOTA-Cetuximab as a scouting radionuclide for tumour uptake with the potential for therapeutic Rhenium-188-DOTA-Cetuximab or Lutetium-177-DOTA-Cetuximab radioimmunotherapy. Administration of all targeted diagnostic molecular imaging is via intravenous infusion. Each patient radiopharmaecutical dose is personalised and will be radio labelled to a Cetuximab dose range of 20 to 100mg as follows: (a) for diagnostic molecular imaging: - Gallium-68 dose activity escalation from 50MBq according to dose estimation as a SINGLE precursor scouting study. (b) for theranostic progression to treatment: - Rhenium-188 dose activity escalation from 500 MBq according to dose estimation. - Lutetium-188 dose activity escalation from 500 MBq according to dose estimation. - Frequency of targeted radioimmunotherapy is to be personalised according to patient response. If there is response to treatment, outpatient intravenous administration can be continued as a monthly dose. Treatment will continue until disease progression or if there is evidence of unacceptable toxicity.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Histological evidence of head and neck squamous cell carcinoma. Disease progression without option for further surgery or radiotherapy (palliation). Able to provide informed consent.

Exclusion criteria

Option for further radiotherapy or salvage surgery Non-squamous cell carcinoma head and neck cancer

Outcome results