BridgeMD
New treatment option for Germ Cell Tumor
Official title Accelerated v's Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours
ClinicalTrials.gov ID: NCT02582697
What this study is testing
What is Bleomycin (active name: Bleomycin Sulfate)?
Bleomycin (active name: Bleomycin Sulfate) is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for germ cell tumor.
Also referred to as Blenamax (Aspen), DBL Bleomycin Sulphate (Willow Pharmaceuticals Pty Limited).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumours.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 11 to 50
You may be able to join if
- Age ≥ 11 years and ≤ 50 years on the date of randomisation
- Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or...
- Primary arising in testis, ovary, retro-peritoneum, or mediastinum
- Metastatic disease or non-testicular primary
- Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and...
You likely can't join if
- Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5...
- Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2...
- Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
- Significant co-morbid respiratory disease that contraindicates the use of bleomycin
- Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus
- Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol...
See the full eligibility criteria
- Age ≥ 11 years and ≤ 50 years on the date of randomisation
- Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or Exceptionally raised tumour markers (AFP ≥ 1000ng/mL and/or HCG ≥ 5000 IU/L) without histologic or cytologic confirmation in the...
- Primary arising in testis, ovary, retro-peritoneum, or mediastinum
- Metastatic disease or non-testicular primary
- Intermediate or poor prognosis as defined by IGCCC classification3 (modified with different LDH criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries). (See protocol for more information).
- Adequate bone marrow function with ANC ≥1.0 x 10\^9/L, Platelet count ≥100 x 10\^9/L
- Adequate liver function where bilirubin must be ≤1.5 x ULN, except participants with Gilbert's Syndrome where bilirubin must be ≤2.0 x ULN; ALT and AST must be ≤2.5 x ULN, except if the elevations are due to hepatic...
- Adequate renal function with estimated creatinine clearance of ≥60 ml/min according to the Cockcroft-Gault formula, unless calculated to be \< 60 ml/min or borderline in which case GFR should be formally measured, eg...
- ECOG Performance Status of 0, 1, 2, or 3
- Study treatment both planned and able to start within 14 days of randomisation.
- Willing and able to comply with all study requirements, including treatment, timing and nature of required assessments
- Able to provide signed, written informed consent
- Other primary malignancy (EXCEPT adequately treated non-melanomatous carcinoma of the skin, germ cell tumour, or other malignancy treated at least 5 years previously with no evidence of recurrence)
- Previous chemotherapy or radiotherapy, except if patient has pure seminoma relapsing after adjuvant radiotherapy or adjuvant chemotherapy with 1-2 doses of single agent carboplatin or if patient hasb. non-seminoma by...
- Significant cardiac disease resulting in inability to tolerate IV fluid hydration for cisplatin
- Significant co-morbid respiratory disease that contraindicates the use of bleomycin
- Peripheral neuropathy ≥ grade 2 or clinically significant sensorineural hearing loss or tinnitus
- Concurrent illness, including severe infection that may jeopardize the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
- Inadequate contraception. Men must use 2 effective methods of contraception, including use of a condom, during chemotherapy and for a year after completing chemotherapy.
- Known allergy or hypersensitivity to any of the study drugs
- Presence of any psychological, familial, sociological or geographical condition that in the opinion of the investigator would hamper compliance with the study protocol and follow-up schedule, including alcohol...
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Newcastle, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Sydney, New South Wales, Australia
- Tweed Heads, New South Wales, Australia
- Wahroonga, New South Wales, Australia
- Brisbane, Queensland, Australia
- South Brisbane, Queensland, Australia
- Woolloongabba, Queensland, Australia
- Adelaide, South Australia, Australia
- Bedford Park, South Australia, Australia
- Hobart, Tasmania, Australia
- Box Hill, Victoria, Australia
- East Melbourne, Victoria, Australia
- Heidelberg, Victoria, Australia
- St Albans, Victoria, Australia
- Wodonga, Victoria, Australia
- Murdoch, Western Australia, Australia
- Grafton, Auckland, New Zealand
- Roslyn, Palmerston North, New Zealand
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 11 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Newcastle, New South Wales, Australia; St Leonards, New South Wales, Australia; Sydney, New South Wales, Australia; Tweed Heads, New South Wales, Australia; Wahroonga, New South Wales, Australia and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.