A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours With Poor Prognosis
Patients will receive a 4 drug combination chemotherapy in hospital over two nights. On the
third day, the patient will receive an injection of pegfilgrastim. This stimulates the bone
marrow to produce white blood cells and shortens the period of risk of serious infection.
The treatment will be repeated every three weeks. This constitutes one cycle of treatment.
We aim to give the patient four cycles of treatment over a total of twelve weeks.
Before each cycle, the following will be conducted - physical examination, full blood count,
urea + electrolytes, liver function tests, LDH, αFP, βHCG.
Patients will have a FDG PET-CT scan at baseline, prior to cycle 2(approximately 1521 days
after chemotherapy starts)and within 28 days of the last treatment, only if clinically
indicated. On each cycle, serum creatinine should be measured 24 hours after the start of
the methotrexate to exclude renal failure due to methotrexate.
The following will be conducted at the end of treatment physical examination, full blood
count, urea + electrolytes, liver function tests, LDH, αFP, βHCG. The patients will be
monitored during chemotherapy and then monthly in the first year and two monthly in the
An interim analysis will be performed after 15 patients have completed treatment. If less
than 9 responses are observed in this group, the study will be terminated. The final
analysis will be performed after 43 patients have recruited, completed treatment and been
followed for 24 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
United Kingdom: Medicines and Healthcare Products Regulatory Agency