None listed
Conditions
Brief summary
This is a study on the safety and effectiveness of accelerated treatment with three chemotherapy drugs (bleomycin, etoposide and cisplatin with pegylated G-CSF) known as ‘accelerated BEP’, in treating people with advanced germ cell tumours. Who is it for? You can join this study if you have germ cell cancer that has spread to distant sites and is widespread. Trial details All participants will receive accelerated BEP chemotherapy intravenously over two week cycles. The number of cycles will be determined by the person’s risk of disease and their response to treatment. Accelerated BEP is a more intense treatment than the standard treatment, and may cause more side effects. This clinical trial will investigate the safety and efficacy of the new regimen as well as its impact on lung function, and neurotoxicity as rated by the participants.
Interventions
Accelerated BEP chemotherapy, consisting of:
- Bleomycin 30000 international units intravenous (IV) days 1 and 8
- Etoposide 100mg/m2 IV days 1, 2, 3, 4, 5
- Cisplatin 20mg/m2 IV days 1, 2, 3, 4, 5
with pegylated G-CSF (pegfilgastrim, Neulasta) 6mg SCI administered on day 6
For patients with intermediate or poor risk disease, treatment is repeated every 2 weeks for 4 cycles. An additional 4 weeks of Bleomycin will be administered if lung function tests allow to a maximum of 12 doses. Total dura
Accelerated BEP chemotherapy, consisting of: - Bleomycin 30000 international units intravenous (IV) days 1 and 8 - Etoposide 100mg/m2 IV days 1, 2, 3, 4, 5 - Cisplatin 20mg/m2 IV days 1, 2, 3, 4, 5 with pegylated G-CSF (pegfilgastrim, Neulasta) 6mg SCI administered on day 6 For patients with intermediate or poor risk disease, treatment is repeated every 2 weeks for 4 cycles. An additional 4 weeks of Bleomycin will be administered if lung function tests allow to a maximum of 12 doses. Total duration – 12 weeks For patients with good risk disease, treatment is repeated every 2 weeks for 3 cycles. An additional 3 weeks of Bleomycin will be administered if lung function tests allow to a maximum of 9 doses. Total duration – 9 weeks
Sponsors
The University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Subjects with histologically proven germ cell tumours (GCT), non-seminoma germ cell tumour (NSGCT) or seminoma arising in testis, retro-peritoneum, mediastinum or ovary- Exceptionally raised tumour markers (Alpha-fetoprotein (AFP) = 1000ng/mL and/or ß-Human chronic gonadotropin (HCG) = 5000 IU/L) are acceptable without histologic confirmation only in male patients with appropriate clinical picture- Relapses on surveillance are also acceptable2. Advanced stage with radiologically measurable disease according to Response Evaluation Criteria in Sold Tumors (RECIST).3. Intermediate risk, poor risk, or selected good risk patients (as defined by modified International Germ Cell Consensus Classification)- Patients must fulfil all of the following criteria in a particular category:- NSGCT – intermediate risk Testis, retro-peritoneal or ovarian primary, and No liver, bone, brain or other non-pulmonary visceral metastases, and Intermediate markers – any of AFP =1,000 and =10,000 µg/L B-HCG = 5,000 and = 50,000 iU/L Lactate dehydrogenase (LDH) = 1.5 x upper limit of normal and = 10 * N upper limit of normal- NSGCT – poor risk Mediastinal primary, or Liver, bone, brain or other non-pulmonary visceral metastases, or Poor markers – any of AFP > 10,000 µg/L B-HCG > 50,000 iU/L LDH > 10 x upper limit of normal- Seminoma - intermediate prognosis Any primary site, and Liver, bone, brain or other non-pulmonary visceral metastases must be present Normal Alpha-fetoprotein (AFP). Any B-HCG. Any LDH- Selected patients with good risk features will also be eligible at investigator’s discretion. These patients must have radiologically measurable disease according to RECIST. Patients with elevated serum tumour markers as the only evidence of disease are ineligible.- NSGCT – good risk Testis/retroperitoneal primary and No non-pulmonary visceral metastases and Good markers – all of AFP <1000 µg/L and B-HCG < 5,000 U/L and LDH < 1.5 x upper limit of normal- Seminoma – good risk Any primary site, and No non-pulmonary visceral metastases and Markers – all of Normal AFP and Any B-HCG Any LDH 4. Adequate bone marrow function (Absolute neutrophil count (ANC) = 1.0 x 109/L, platelet count =100 x 109/L)5. Adequate hepatic function (Bilirubin must be = 1.5 x upper limit of normal range, alanine aminotransferase (ALT) and alkaline phosphatase (ALP) must be = 2.5 x upper limit of normal (ULN) except if the elevations are due to metastatic disease6. Adequate renal function (glomerular filtration rate (GFR) estimated with the Cockcroft-Gault formula = 60 ml/min).7. Able to commence treatment within 7 days of enrolment8. Able to comply with all treatment, assessments and follow-up9. Written, informed consent
Exclusion criteria
2. Previous malignancy (other than germ cell malignancy, basal cell carcinoma or non-invasive squamous cell carcinoma of skin)3. Previous chemotherapy or radiotherapy, except patients with pure seminoma relapsing after radiotherapy.4. Uncontrolled medical condition including significant cardiac disease resulting in inability to tolerate intravenous fluid hydration for cisplatin5. Peripheral neuropathy = grade 2 or clinically significant sensori-neural hearing loss or tinnitus (audiometric abnormalities without corresponding clinical deafness are not grounds for exclusion)6. Medical or psychiatric condition disorder that compromises the patient’s ability to give informed consent7. Known hypersensitivity to cisplatin, etoposide, bleomycin or pegfilgrastrim (Neulasta)
Outcome results
None listed