A NOVEL HYBRID PROTOCOL FOR RELAPSED GERM CELL TUMOURS WITH POOR PROGNOSIS - GAMIO

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005295-27-GB

Enrollment

Registered

2009-04-16

Start date

2009-05-14

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed Germ Cell Tumour with poor prognosis

Interventions

Product Name: Methotrexate Pharmaceutical Form: Solution for injection Trade Name: Neulasta Product Name: pegfilgrastim Pharmaceutical Form: Solution for injection Product Name: Oxaliplatin Pharmace

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: INCLUSION 1. Germ Cell Tumour (GCT) 2. Relapsed or progression on or following platinum-based chemotherapy (rising tumour markers or progressive disease on CT) 3. Neutrophil count > 1.0 x109/l 4. Platelets > 70 x109/l 5. Haemoglobin > 100g/l (may be transfused) 6. Calculated Creatinine clearance > 60mls/min or EDTA clearance of > 40ml/min 7. Age 16-65 years (Patient under 35 must have a raised LDH at relapse) 8. ECOG Performance status 0-3 9. FDG-PET CT scans prior to chemotherapy (within 14 days of study entry). Are the trial subjects under 18? yes 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: EXCLUSION 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 Unable or unwilling to give written informed consent

Design outcomes

Primary

Measure	Time frame
Secondary Objective: ;Primary end point(s): PRIMARY ENDPOINTS • FDG PET-CT Scan metabolic response • Toxicity • Objective response rate ;Main Objective: 1. To establish the response rates to GAMIO 2. To establish the safety and efficacy of substitution of oxaliplatin and irinotecan for cisplatin and etoposide 3. To establish the toxicity of GAMIO 4. To establish progression free survival (PFS) 5. To ascertain whether a repeat FDG PET-CT scan at 14 days (after 1 cycle of therapy but prior to cycle 2) may predict long-term, progression-free survival following GAMIO.	—

Measure

Time frame

Secondary Objective: ;Primary end point(s): PRIMARY ENDPOINTS • FDG PET-CT Scan metabolic response • Toxicity • Objective response rate ;Main Objective: 1. To establish the response rates to GAMIO 2. To establish the safety and efficacy of substitution of oxaliplatin and irinotecan for cisplatin and etoposide 3. To establish the toxicity of GAMIO 4. To establish progression free survival (PFS) 5. To ascertain whether a repeat FDG PET-CT scan at 14 days (after 1 cycle of therapy but prior to cycle 2) may predict long-term, progression-free survival following GAMIO.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026