Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)
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ClinicalTrials.gov Identifier: NCT00204633 |
Recruitment Status :
Completed
First Posted : September 20, 2005
Last Update Posted : February 16, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dysgerminoma | Drug: Darbepoetin alfa | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 108 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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) |
Study Start Date : | July 2003 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | December 2008 |

- frequency of transfusions (reduction from 90% to 65%)
- proportion of patients with no transfusions
- developing of hemoglobin levels
- objective remission rate
- progression-free- and overall-survival (pfs, os)
- quality of life

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Performance-Status: WHO =< 2
- Written informed consent
- Ability to give informed consent
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00204633
Germany | |
Medical Center II, University of Tuebingen | |
Tuebingen, Germany, 72076 |
Principal Investigator: | Joerg T. Hartmann, MD | South West German Cancer Center, Medical Center II, University of Tuebingen |
ClinicalTrials.gov Identifier: | NCT00204633 |
Other Study ID Numbers: |
jth_004 |
First Posted: | September 20, 2005 Key Record Dates |
Last Update Posted: | February 16, 2009 |
Last Verified: | February 2009 |
Neoplasms, Germ Cell and Embryonal Dysgerminoma Neoplasms by Histologic Type Neoplasms |
Germinoma Darbepoetin alfa Hematinics |