NCT06309732

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

GAMEC-SHORT (S) & GAMEC-ANTHRACYCLINE(A) (Combination Chemotherapy With GCSF, Actinomycin-D, Methotrexate, Etoposide and Cisplatin) Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: Male
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

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.

Detailed description

GAMEC-II (GAMEC -S \& GAMEC-A) is an open-labelled, non-randomised clinical trial in patients with relapsed germ cell tumours (GCT) and its objectives are: 1. To establish the response rates to GAMEC-S or GAMEC-A 2. To establish the safety and efficacy of substitution of epirubicin for etoposide (GAMEC-A regimen) 3. To establish the toxicity of GAMEC-A 4. To establish progression free survival (PFS) 5. To establish whether shortening GAMEC-S in patients without adverse prognostic factors reduces toxicity without compromising survival.

Conditions

• Testicular Neoplasms

Interventions

Type	Name	Description
DRUG	Pegfilgrastim	6mg at each cycle
DRUG	Dactinomycin	1mg/m2
DRUG	Methotrexate	Doses are titrated against renal function. Dosage: 30 mins loading plus 12 hour infusion
DRUG	Etoposide	90mg/m2 injection for infusion
DRUG	Cisplatin	50mg/m2
DRUG	Epirubicin	37.5mg/m2

Timeline

• Start date: 2006-07-01
• Primary completion: 2013-06-01
• Completion: 2014-01-01
• First posted: 2024-03-13
• Last updated: 2024-03-13

Locations

1 site across 1 country: United Kingdom