A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours With Poor Prognosis
Status:
Unknown status
Trial end date:
2021-01-01
Target enrollment:
Participant gender:
Summary
The treatment of germ cell tumours is considered to be one of the major successes in the area
of cytotoxic chemotherapy. Even in patients who relapse after first line therapy, a durable
remission rate of between 25% and 60% has been seen using further chemotherapy. In 1999,
researchers at St Bartholomew's Hospital developed the GAMEC protocol (combination
chemotherapy with filgrastim, actinomycin D, methotrexate, etoposide, cisplatin). Results
from this study showed that 50% of patients with relapsed testicular cancer could be cured
using this treatment. When we reviewed the individual patients it was clear that older
patients (>35yrs) or patients with a raised Lactate Dehydrogenase (a blood test that 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. We have
been developing a study for patients who fulfil at least one of these criteria. The GAMIO
study (filgrastim, actinomycin D, methotrexate, irinotecan, oxaliplatin) has recently closed
due to problems with high levels of toxicity from the irinotecan. GAMMA is a new study that
will use paclitaxel instead of irinotecan and oxaliplatin instead of cisplatin. We expect
that this treatment with oxaliplatin will be less damaging to the kidneys than cisplatin.
Both oxaliplatin and paclitaxel and oxaliplatin and irinotecan have similar activity in
relapsed patients in the phase II setting. We hope to improve on our previous results with
this substitution and see if this will lead to an improvement in the cure rate of relapsed
germ cell tumours with poor prognosis and reduce the side effects compared to our standard
treatment. In addition, we do not expect any hearing damage and the treatment requires a
shorter hospital stay.