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)

4491

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.

2006-07-01

2013-06-01

2014-01-01

Completed

Early phase I

36

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}

2024-03-13