GAMIO Version 1 Final

• Research type

  Research Study

• Full title

  A NOVEL HYBRID PROTOCOL FOR RELAPSED GERM CELL TUMOURS WITH POOR PROGNOSIS

• IRAS ID

  3662

• Sponsor organisation

  St Bartholomew's and The London NHS Trust

• Eudract number

  2008-005295-27

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  We have recently completed a study using the regimen GAMEC (filgrastim, actinomycin-D, methotrexate, etoposide, cisplatin). The results of this study showed that 50% of patients with relapsed testicular cancer could be cured using this treatment. These results are very encouraging and compare very favourably to other treatment protocols. When we reviewed the individual patients it became clear that older patients (over 35 years of age) or patients with a raised LDH (Lactate Dehydrogenase) - a blood test which monitors cancer activity did not do as well. In addition patients whose original tumour started in their chest (mediastinal germ cell tumour) have tended to do badly if they relapse. For patients who fulfil at least one of these criteria, we would like to see whether we can improve on our previous results by substituting for two drugs (Oxaliplatin and Irinotecan) which have shown to be effective when GAMEC has failed and to see if this will lead to an improvement in the cure rate of relapsed germ cell tumours with poor prognosis.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/51

• Date of REC Opinion

  8 Apr 2009

• REC opinion

  Favourable Opinion