Extragonadal Germ Cell TumorPhase 2NCT00453232
Combination Chemotherapy and Pegfilgrastim in Treating Men With Metastatic Germ Cell Tumors
A Phase 2 study testing bleomycin sulfate, pegfilgrastim and cisplatin in people with Extragonadal Germ Cell Tumor and Teratoma, run by Cambridge University Hospitals NHS Foundation Trust at 7 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Extragonadal Germ Cell Tumor, Teratoma, Testicular Germ Cell Tumor
- What is being tested?
- bleomycin sulfate, pegfilgrastim and cisplatin
- How many people
- 20 participants
- Where
- 7 sitesUnited Kingdom
- Study dates
- Aug 2004to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Patients must fulfill all of the following criteria for 1 of the following diagnoses:
- Nonseminoma germ cell tumor (intermediate risk)
- Testis or retroperitoneal primary
- Abnormal markers (alpha fetoprotein [AFP] > 1,000 and < 10,000 ng/mL, human chorionic gonadotropin [HCG] > 5,000 and < 50,000 IU/L, lactate dehydrogenase [LDH] > 1.5 times and < 10 times upper limit of normal [ULN])
- No liver, bone, brain, or other nonpulmonary visceral metastasis
- Histologic confirmation is not required if AFP or HCG are grossly elevated
- Nonseminoma germ cell tumor (poor prognosis) meeting 1 of the following criteria:
- Mediastinal primary
- Nonpulmonary visceral metastases
- Poor markers (AFP > 10,000 ng/mL, HCG > 50,000 IU/L, LDH > 10 times ULN)
- Histologic confirmation not required if AFP or HCG are grossly elevated
- Seminoma (intermediate prognosis)
- Histological confirmation is required
- Any primary site
- Nonpulmonary visceral metastases must be present
- Normal AFP
- Any HCG
- Any LDH
- Surveillance relapse
- Must fulfill appropriate criteria above according to initial histology
PATIENT CHARACTERISTICS:
- Neutrophil count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Must have adequate renal function (creatinine clearance ≥ 60 mL/min)
- No prior malignancy except basal cell carcinoma
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United Kingdom7 sites
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G11 6NT
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Saint Bartholomew's Hospital
London, England, EC1A 7BE
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, NE4 6BE
Churchill Hospital
Oxford, England, OX3 7LJ
About this study
Official title: Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor
RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the feasibility of accelerated treatment comprising bleomycin, etoposide, cisplatin, and pegfilgrastim in men with metastatic germ cell tumors.
- Determine the toxicity of this regimen (particularly with respect to renal, pulmonary, and neurological function) in these patients.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
OUTLINE: This is a non-randomized, pilot study.
Patients receive etoposide IV on days 1-3, cisplatin IV on days 1 and 2, and bleomycin IV over 2 hours on days 2, 6, and 10. Patients also receive pegfilgrastim subcutaneously on day 4. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
- Being tested
- bleomycin sulfate, pegfilgrastim, cisplatin, etoposide
- Keywords
- stage III malignant testicular germ cell tumor, testicular choriocarcinoma and seminoma, testicular embryonal carcinoma and seminoma, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma, testicular choriocarcinoma and yolk sac tumor, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular embryonal carcinoma, testicular seminoma, testicular yolk sac tumor, testicular yolk sac tumor and teratoma with seminoma, testicular yolk sac tumor and teratoma, recurrent malignant testicular germ cell tumor, recurrent extragonadal non-seminomatous germ cell tumor, recurrent extragonadal seminoma, stage IV extragonadal non-seminomatous germ cell tumor
- Medical subject headings
- Teratoma, Testicular Germ Cell Tumor, Testicular Neoplasms, Seminoma, Carcinoma, Embryonal, Endodermal Sinus Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bleomycin sulfateBiological
pegfilgrastimBiological
cisplatinDrug
etoposideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicity
Feasibility
Secondary outcomes (2)
Response rate
Progression-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2007 (estimated)
- Study startAug 2004
- Primary completionDec 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extragonadal Germ Cell TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Michael Williams, MD, Study chair, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453232
- Sponsor's protocol ID
- CRCA-CCTC-ACCELERATED-BEP
- Other IDs
- CDR0000537042, EUDRACT-2004-000847-79, EU-20713, ISRCTN18505589
- Status last verified
- Aug 2007
- First submitted
- 27 Mar 2007
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated BEP Chemotherapy for Intermediate and High Risk Metastatic Germ Cell Tumor
- ClinicalTrials.gov ID
- NCT00453232
- Acronym / sponsor ID
- CRCA-CCTC-ACCELERATED-BEP
- Keywords
- stage III malignant testicular germ cell tumor, testicular choriocarcinoma and seminoma, testicular embryonal carcinoma and seminoma, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma, testicular choriocarcinoma and yolk sac tumor, testicular embryonal carcinoma and teratoma with seminoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 28 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with pegfilgrastim works in treating men with metastatic germ cell tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the feasibility of accelerated treatment comprising bleomycin, etoposide, cisplatin, and pegfilgrastim in men with metastatic germ cell tumors.
- Determine the toxicity of this regimen (particularly with respect to renal, pulmonary, and neurological function) in these patients.
Secondary
- Determine the response rate in patients treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
OUTLINE: This is a non-randomized, pilot study.
Patients receive etoposide IV on days 1-3, cisplatin IV on days 1 and 2, and bleomycin IV over 2 hours on days 2, 6, and 10. Patients also receive pegfilgrastim subcutaneously on day 4. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bleomycin sulfate | Biological | – |
| pegfilgrastim | Biological | – |
| cisplatin | Drug | – |
| etoposide | Drug | – |
Primary outcome
Toxicity
Feasibility
2 secondary outcomes
Response rate
Progression-free survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
Related trials for Extragonadal Germ Cell Tumor
RecruitingPhase 3
Active Surveillance, Bleomycin, Etoposide, Carboplatin or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors
Childhood Extracranial Germ Cell Tumor, Extragonadal Embryonal Carcinoma
Active, not recruitingPhase 3
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors
Germ Cell Tumor, Teratoma
RecruitingPhase 2
High-dose Chemotherapy as Second-line Drug Therapy for Relapsed Germ Cell Tumors
Germ Cell Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Williams, MD study chair
Cambridge University Hospitals NHS Foundation Trust
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bleomycin sulfate, pegfilgrastim and cisplatin in people with Extragonadal Germ Cell Tumor and Teratoma, run by Cambridge University Hospitals NHS Foundation Trust at 7 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.