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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)


Phase 2
18 Years
65 Years
Not Enrolling
Male
Dysgerminoma

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Trial Information

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)


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/┬Ál)

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

frequency of transfusions (reduction from 90% to 65%)

Principal Investigator

Joerg T. Hartmann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

South West German Cancer Center, Medical Center II, University of Tuebingen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

jth_004

NCT ID:

NCT00204633

Start Date:

July 2003

Completion Date:

December 2008

Related Keywords:

  • Dysgerminoma
  • Dysgerminoma
  • Neoplasms, Germ Cell and Embryonal

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