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

NCT06309732 | Completed Phase 2

• 3 other identifiers: 44912006-001963-52TE 2006-09
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Testicular Neoplasms

Keywords

Germ cell tumour

Outcome Measures

Primary Outcomes (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)

  6 weekly

Secondary Outcomes (2)

• Relapse-free survival

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

• Overall survival

  5 years

Study Arms (2)

GAMEC - S

EXPERIMENTAL

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; Drug: Methotrexate; Drug: Etoposide; Drug: Cisplatin

GAMEC-A

EXPERIMENTAL

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: Pegfilgrastim; Drug: Dactinomycin; Drug: Methotrexate; Drug: Cisplatin; Drug: Epirubicin

Interventions

Pegfilgrastim DRUG

6mg at each cycle

Also known as: Neupogen, Ratiograstim, Zarzio

GAMEC-A

Dactinomycin DRUG

1mg/m2

Also known as: Cosmegen Lyovac

GAMEC - S; GAMEC-A

Methotrexate DRUG

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

GAMEC - S; GAMEC-A

Etoposide DRUG

90mg/m2 injection for infusion

Also known as: Etopophos

GAMEC - S

Cisplatin DRUG

50mg/m2

GAMEC - S; GAMEC-A

Epirubicin DRUG

37.5mg/m2

GAMEC-A

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Barts and the London NHS Trust

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Testicular Neoplasms; Neoplasms, Germ Cell and Embryonal

Interventions

pegfilgrastim; Filgrastim; Dactinomycin; Methotrexate; Etoposide; etoposide phosphate; Cisplatin; Epirubicin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Glucosides; Glycosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides

Study Officials

• Jonathan Shamash

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2014
• First Posted: March 13, 2024
• Study Start: July 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: January 1, 2014
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

GB (1)