A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours With Poor Prognosis

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

May 1, 2012

Primary Completion Date

May 5, 2021

Study Completion Date

May 5, 2021

Conditions
Germ Cell Tumour
Interventions
DRUG

Combination Chemotherapy

"4 cycles of: Day 1 Actinomycin D 1mg/m2, Paclitaxel 80mg/m2, Methotrexate Day 4 Oxaliplatin 100mg/m2 Pegfilgrastim 6mg Day 8\* Paclitaxel 80mg/m2 Day 15 Paclitaxel 80mg/m2~\*Day 8 will be omitted for the first three patients treated in this study and will be given at the end of treatment in a fifth cycle where Paclitaxel 80mg/m2 will be administered on Days 1, 8, 15 and 22. Before adding the extra Paclitaxel 80mg/m2 dose on day 8 the safety data for these patients will be reviewed by a DMC.~NB This 5th cycle for patients 1-3 has been included to ensure that the four 'missed doses of paclitaxel are not omitted from the patients treatment regimen. Cycles 1-4 are 21 days cycles; Cycle 5 (for the first three patients only) is a 28 day cycle."

Trial Locations (1)

EC1A 7BE

St Bartholomew's Hospital, London

All Listed Sponsors
lead

Barts & The London NHS Trust

OTHER

NCT01782339 - A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours With Poor Prognosis | Biotech Hunter | Biotech Hunter