Relapsed Germ Cell Tumour with poor prognosis
Conditions
Interventions
Trade Name: Methotrexate
Product Name: Methotrexate
Pharmaceutical Form: Solution for injection
Trade Name: Neulasta
Product Name: Pegf
Sponsors
Barts and the London NHS Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Germ Cell Tumour (GCT) 2. Relapsed or progression on or following platinum-based chemotherapy (rising tumour markers or progressive disease on PET CT Scan prior to entering study) 3. Neutrophil count >1.0x109/l 4. Platelets >70x109/l 5. Haemoglobin >100g/l (may be transfused) 6. Glomerular filtration rate >40ml/min 7. ALT up 2.5 x ULN 8. Men aged 16-65 years Patients under 35 must have: i) A raised LDH (more than 480) at relapse or ii) Have a mediastinal non-seminomatous germ cell tumour or iii) Have a contraindication to further cisplatin based chemotherapy 9. Patients must be sterile or agree to use adequate contraception during the period of therapy 10. ECOG Performance status 0-3 11. Able and willing to give written informed consent and comply with the protocol study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Other malignancy except basal cell carcinoma 2. Significant co-morbidity likely to make delivery of this treatment unsafe 3. Currently enrolled in any other investigational drug study 4. Previous chemotherapy with oxaliplatin, methotrexate or Actinomycin D
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine complete response and negative marker partial response. Response assessment (stable disease (SD), partial response (PR) or complete response (CR)) determined according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1) in all patients receiving at least two cycles of treatment;Secondary Objective: - To ascertain whether a repeat FDG PET-CT scan at 15-21 days (after one cycle of therapy but prior to cycle 2) may predict long-term progression-free survival following treatment, - To study the overall survival - To assess the safety and toxicity of Pegfilgrastim, Actinomycin D, Methotrexate, Paclifaxel and Oxaliplatin;Primary end point(s): Complete response and negative marker partial response. Response assessment (stable disease (SD), partial response (PR) or complete response (CR)) determined according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1) in all patients receiving at least two cycles of treatment. | — |
Countries
United Kingdom
Outcome results
None listed