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Testicular NeoplasmsPhase 2GAMEC-IINCT06309732

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

A Phase 2 study testing Pegfilgrastim, Dactinomycin and Methotrexate in people with Testicular Neoplasms, run by Queen Mary University of London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 35 years, men only
Conditions the study is for
Testicular Neoplasms
What is being tested?
Pegfilgrastim, Dactinomycin and Methotrexate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited Kingdom
Study dates
Jul 2006to Jan 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 35 years
  • Men only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Barts and the London NHS Trust

    London, EC1A 7BE

Other trials in United Kingdom

About this study

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)

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.

Read the 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.
Being tested
Pegfilgrastim, Dactinomycin, Methotrexate, Etoposide, Cisplatin
Keywords
Germ cell tumour
Medical subject headings
Testicular Neoplasms, Neoplasms, Germ Cell and Embryonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PegfilgrastimDrug

    Also called Neupogen, Ratiograstim, Zarzio

    6mg at each cycle

  • DactinomycinDrug

    Also called Cosmegen Lyovac

    1mg/m2

  • MethotrexateDrug

    Doses are titrated against renal function. Dosage: 30 mins loading plus 12 hour infusion

  • EtoposideDrug

    Also called Etopophos

    90mg/m2 injection for infusion

  • CisplatinDrug

    50mg/m2

  • EpirubicinDrug

    37.5mg/m2

Study groups in NCT06309732
Study groupRoleWhat they receive
GAMEC - SExperimentalDay 4 PEG Filgrastim 6mg Day 1 Actinomycin D 1mg/m2 Day 1 Methotrexate (dependent on creatinine clearance) Days 1,2, 3, 4 Etoposide 90mg/m2 Days 2, 3 Cisplatin 50mg/m2 Day 8 Cisplatin 50mg/m2 (cycle 1\&2 only)
Receives: Drug: Dactinomycin; Drug: Methotrexate; Drug: Etoposide; Drug: Cisplatin
GAMEC-AExperimentalDay 1 Actinomycin-D 1m/m2 Day 2, 3 and 8 Methotrexate 8g/m2 (dependent on creatinine clearance) Day 2, 3 and 8 Cisplatin 50mg/m2 (Day 8 dose omitted from week 6 onwards) Day 1 and 2 Epirubicin 37.5mg/m2 Day 3 Pegfilgrastim 6mg Treatment given on weeks 1, 3, 6, 8 and 10.
Receives: Drug: Pegfilgrastim; Drug: Dactinomycin; Drug: Methotrexate; Drug: Cisplatin; Drug: Epirubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate to GAMEC-S or GAMEC-A

    Tumour markers, clinical and radiological assessment of disease and/or examination of resected tissue (if surgery is done)

    Measured: 6 weekly

Secondary outcomes (2)

  1. Relapse-free survival

    CT-scan chest, abdomen and pelvis (continued pelvic scanning is dependent whether disease present)

    Measured: Monthly for 1 year, 2 monthly for 2nd year, 3 monthly 3rd year, annually there after

  2. Overall survival

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2024
  2. Study startJul 2006
  3. Primary completionJun 2013
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06309732
Sponsor's protocol ID
4491
Other IDs
2006-001963-52, TE 2006-09
Acronym
GAMEC-II
Status last verified
Mar 2024
First submitted
9 Sep 2014
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegfilgrastim, Dactinomycin and Methotrexate in people with Testicular Neoplasms, run by Queen Mary University of London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate to GAMEC-S or GAMEC-A (time frame: 6 weekly). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06309732.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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