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

March 7, 2024 updated by: Queen Mary University of London

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Barts and The London NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GAMEC - S
Day 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)
Drug: Dactinomycin
1mg/m2
Other Names:
  • Cosmegen Lyovac
Drug: Methotrexate
Doses are titrated against renal function. Dosage: 30 mins loading plus 12 hour infusion
Drug: Etoposide
90mg/m2 injection for infusion
Other Names:
  • Etopophos
Drug: Cisplatin
50mg/m2
Experimental: GAMEC-A
Day 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.
Drug: Dactinomycin
1mg/m2
Other Names:
  • Cosmegen Lyovac
Drug: Methotrexate
Doses are titrated against renal function. Dosage: 30 mins loading plus 12 hour infusion
Drug: Cisplatin
50mg/m2
Drug: Pegfilgrastim
6mg at each cycle
Other Names:
  • Neupogen
  • Zarzio
  • Ratiograstim
Drug: Epirubicin
37.5mg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 weekly

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
5 years
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)
Monthly for 1 year, 2 monthly for 2nd year, 3 monthly 3rd year, annually there after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Investigators

  • Principal Investigator: Jonathan Shamash, Barts & The London NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2006

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 9, 2014

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4491
  • 2006-001963-52 (EudraCT Number)
  • TE 2006-09 (Other Identifier: Barts and the London NHS Trust)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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