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NCT Number: NCT06309732

GAMEC-II, 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.

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Key information

Conditions

Testicular Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Testicular Diseases Urogenital Diseases Urogenital Neoplasms

Age range

16 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Barts and the London NHS Trust

London, EC1A 7BE, United Kingdom

About this study

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:

  • To establish the response rates to GAMEC-S or GAMEC-A
  • To establish the safety and efficacy of substitution of epirubicin for etoposide (GAMEC-A regimen)
  • To establish the toxicity of GAMEC-A
  • To establish progression free survival (PFS)
  • To establish whether shortening GAMEC-S in patients without adverse prognostic factors reduces toxicity without compromising survival.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pegfilgrastim

Drug

6mg at each cycle

Other names: Neupogen, Ratiograstim, Zarzio

Dactinomycin

Drug

1mg/m2

Other names: Cosmegen Lyovac

methotrexate

Drug

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

etoposide

Drug

90mg/m2 injection for infusion

Other names: Etopophos

Cisplatin

Drug

50mg/m2

Epirubicin

Drug

37.5mg/m2

Primary outcomes

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

    Time frame: 6 weekly

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

Secondary outcomes

  1. Relapse-free survival

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

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

  2. Overall survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study 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)

Acronym: GAMEC-II

Important dates

Study start
2006
Primary completion
2013
Study completion
2014
First posted
Mar 13, 2024
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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