Darbepoetin Alfa in Patients With "Poor Prognosis" Germ Cell Tumor Treated With High-Dose Chemotherapy (HD-VIP)

NCT00204633 | Completed Phase 2

• 1 other identifier: jth_004
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dysgerminoma

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Darbepoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

Medical Center II, University of Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Dysgerminoma

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Joerg T. Hartmann, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2003
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 16, 2009

Record last verified: 2009-02

Locations

DE (1)