DysgerminomaPhase 2NCT00204633
Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)
A Phase 2 study testing Darbepoetin alfa in people with Dysgerminoma, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The aim is to determine the frequency of RBC transfusion in patients with metastatic "poor prognosis" germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without Darbepoetin alfa Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Dysgerminoma
- What is being tested?
- Darbepoetin alfa
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2003to Dec 2008
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Poor prognosis" according IGCCCG-criteria:
- Primary mediastinal tumor
- Gonadal/retroperitoneal germ cell tumor with visceral metastases except of lung
- Poor marker: AFP > 10.000 ng/ml or beta-HCG > 10.000 ng/ml (50.000 IU/l) andd LDH >10 x upper normal limit
- No previous chemotherapy
- Age > 18 years
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- Performance-Status: WHO =< 2
- Written informed consent
- Ability to give informed consent
Who cannot join
- Hemolysis
- Hematological disease with insufficient erythropoiesis
- Patients without sufficient treatment of sideropenia, folate deficiency or vitamin B12 deficiency
- Uncontrolled arterial hypertension
- Treatment with rh-Erythropoetin during trial
- Creatinin clearance < 50 ml/min
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- Insufficient bone marrow function (WBC count < 3.000/ml or platelets < 100.000/µl)
- Other major symptomatic or uncontrolled illnesses not allowing to complete treatment protocol with the exception of symptoms caused by the primary disease
- Second malignancy, except of completely resected basal cell carcinoma of the skin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II-Trial to Determine the Impact of Darbepoetin Alfa on the Frequency of RBC Transfusions in Patients With Metastatic "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP Regimen)
The aim is to determine the frequency of RBC transfusion in patients with metastatic "poor prognosis" germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without Darbepoetin alfa
- Conditions
- Dysgerminoma
- Being tested
- Darbepoetin alfa
- Medical subject headings
- Dysgerminoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Darbepoetin alfaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of transfusions (reduction from 90% to 65%)
Secondary outcomes (5)
proportion of patients with no transfusions
developing of hemoglobin levels
objective remission rate
progression-free- and overall-survival (pfs, os)
quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysgerminomaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Joerg T. Hartmann, MD, Principal investigator, South West German Cancer Center, Medical Center II, University of Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204633
- Sponsor's protocol ID
- jth_004
- Status last verified
- Feb 2009
- First submitted
- 13 Sep 2005
- Last updated
- 16 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II-Trial to Determine the Impact of Darbepoetin Alfa on the Frequency of RBC Transfusions in Patients With Metastatic "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP Regimen)
- ClinicalTrials.gov ID
- NCT00204633
- Acronym / sponsor ID
- jth_004
- Conditions
- Dysgerminoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Sep 2005 (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.
The aim is to determine the frequency of RBC transfusion in patients with metastatic "poor prognosis" germ cell tumor during high-dose chemotherapy (HD-VIP, level 6) with or without Darbepoetin alfa
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Poor prognosis" according IGCCCG-criteria:
- Primary mediastinal tumor
- Gonadal/retroperitoneal germ cell tumor with visceral metastases except of lung
- Poor marker: AFP > 10.000 ng/ml or beta-HCG > 10.000 ng/ml (50.000 IU/l) andd LDH >10 x upper normal limit
- No previous chemotherapy
Key exclusion criteria (9 listed)
- Hemolysis
- Hematological disease with insufficient erythropoiesis
- Patients without sufficient treatment of sideropenia, folate deficiency or vitamin B12 deficiency
- Uncontrolled arterial hypertension
- Treatment with rh-Erythropoetin during trial
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 |
|---|---|---|
| Darbepoetin alfa | Drug | – |
Primary outcome
frequency of transfusions (reduction from 90% to 65%)
5 secondary outcomes
proportion of patients with no transfusions
developing of hemoglobin levels
objective remission rate
progression-free- and overall-survival (pfs, os)
quality of life
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 16 Feb 2009.
Related trials for Dysgerminoma
Active, not recruitingPhase 2
Evaluating Immune Therapy, Duravalumab (MEDI4736) With Tremelimumab for Relapsed/Refractory Germ Cell Tumors
Germ Cell Tumor, Nonseminomatous 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.
Joerg T. Hartmann, MD principal investigator
South West German Cancer Center, Medical Center II, University of Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Darbepoetin alfa in people with Dysgerminoma, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. 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 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
frequency of transfusions (reduction from 90% to 65%). 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 16 Feb 2009.