Clinical trial NCT06309732: GAMEC-II, Risk-adapted Protocol for Relapsed Germ Cell Tumours (GCT)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Testicular Neoplasms
Keywords: Germ cell tumour
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 36
Sex: MALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Germ Cell Tumour (GCT), relapsed or progressing on or following platinum-based chemotherapy - as evidenced by rising tumour markers or progressive disease on CT scan
* Neutrophil count \>1.0 x109/l
* Platelets \>70 x109/l
* Haemoglobin \>100g/l (may be transfused)
* Creatinine clearance should be \>60ml/min. However, if creatinine clearance \<60 ml/min then an EDTA clearance is MANDATORY. (If EDTA clearance is \<60 ml/min then the patient will be excluded.)
* Males age \>16 ≤35 years \[decision made on physical fitness to participate\]
* ECOG Performance status 0-3
* Full written consent

Exclusion Criteria:

* Other malignancy except basal cell carcinoma
* Evidence of clinically significant cardiac failure, unstable angina or uncontrolled hypertension
* Current participation in any other investigational drug study

Primary outcomes:
measure: Response rate to GAMEC-S or GAMEC-A
timeFrame: 6 weekly
Secondary outcomes:
measure: Relapse-free survival
timeFrame: Monthly for 1 year, 2 monthly for 2nd year, 3 monthly 3rd year, annually there after
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts and the London NHS Trust
Study officials:
affiliation: Barts & The London NHS Trust
name: Jonathan Shamash
role: PRINCIPAL_INVESTIGATOR
References: