Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-28 @ 5:34 PM
Study NCT ID:
NCT06309732
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2014-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT)
Sponsor:
Queen Mary University of London
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GAMEC-II
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: