drugset / Trial / NCT06309732

GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT)

NCT06309732

Phase 2 Completed 36 enrolled Queen Mary University of London
Non-randomizedParallel-groupOpen-labelTreatment

Summary

St Bartholomew's hospital completed a study using the regimen GAMEC (PEG-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. In reviewing this study, it became clear that of the 5 cycles of treatment which were proposed, the first 3 seemed to matter and the last 2 did not appear important. In addition there was a group of patients who appeared to do particularly well namely patients under the age of 35 and those who had a normal LDH (lactate dehydrogenase). LDH is a blood test which monitors cancer activity. Selecting patients which fill both these criteria, this trial aims to see whether the investigators can maintain the good results the investigators have seen but using only 3 cycles of treatment. This will therefore shorten the treatment from 10 weeks to 6 weeks, thus reducing the side effects.

Timeline

Start
2006-07
Primary completion
2013-06
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 50 mg/m2
Subject Dactinomycin Protein / enzyme biologic 1 mg/m2
Subject Epirubicin Small molecule 37.5 mg/m2
Subject Etoposide Small molecule 90 mg/m2
Subject Methotrexate Small molecule 8 g/kg
Background Pegfilgrastim Protein / enzyme biologic 6 mg