A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours with Poor Prognosis - GAMMA

Phase 1

• Conditions: Relapsed Germ Cell Tumour with poor prognosis

• Registration Number: EUCTR2010-022795-31-GB
• Lead Sponsor: Barts and the London NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-23
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 43

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.