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

NCT ID: NCT06309732

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2014-01-31

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.

Conditions

Testicular Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Dactinomycin

Intervention Type: DRUG

1mg/m2

Methotrexate

Intervention Type: DRUG

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

Etoposide

Intervention Type: DRUG

90mg/m2 injection for infusion

Cisplatin

Intervention Type: DRUG

50mg/m2

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.

Group Type: EXPERIMENTAL

Pegfilgrastim

Intervention Type: DRUG

6mg at each cycle

Dactinomycin

Intervention Type: DRUG

1mg/m2

Methotrexate

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

50mg/m2

Epirubicin

Intervention Type: DRUG

37.5mg/m2

Interventions

Pegfilgrastim

6mg at each cycle

Intervention Type: DRUG

Dactinomycin

1mg/m2

Intervention Type: DRUG

Methotrexate

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

Intervention Type: DRUG

Etoposide

90mg/m2 injection for infusion

Intervention Type: DRUG

Cisplatin

50mg/m2

Intervention Type: DRUG

Epirubicin

37.5mg/m2

Intervention Type: DRUG

Other Intervention Names

Neupogen; Ratiograstim; Zarzio; Cosmegen Lyovac; Etopophos

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Shamash

Role: PRINCIPAL_INVESTIGATOR

Barts & The London NHS Trust

Locations

Barts and the London NHS Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2006-001963-52

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TE 2006-09

Identifier Type: OTHER

Identifier Source: secondary_id

4491

Identifier Type: -

Identifier Source: org_study_id