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Prednisone Oral |
Deltasone |
Clinical Trial: Phase I/II Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Elderly Patients with Advanced Stages Hodgkin''s Lymphoma
This study is currently recruiting patients.
Verified by University of Cologne August 2005
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Purpose
The objectives of this study are to assess the feasibility and efficacy of a combination chemotherapy (PVAG) in elderly patients with advanced stages Hodgkin''''s lymphoma
| Condition | Intervention | Phase |
|---|---|---|
| Hodgkin''''s Disease | Drug: Prednisone Drug: Vinblastine Drug: Doxorubicin (Adriamycin) Drug: Gemcitabine | Phase I Phase II |
MedlinePlus related topics: Hodgkin''''s Disease
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) with Advanced Stages Hodgkin''''s Lymphoma
Further Study Details:
Primary Outcomes: Phase I: Dose-limiting toxicities and dose reductions; Phase II: Treatment administration and complete response rate
Secondary Outcomes: Toxicities; Supportive care (RBCT need, antibiotic need); Early progression rate; Overall survival
Expected Total Enrollment: 40
Secondary Outcomes: Toxicities; Supportive care (RBCT need, antibiotic need); Early progression rate; Overall survival
Expected Total Enrollment: 40
Study start: March 2004
Gemcitabine shows promising activity in patients with relapsed lymphoma either administered as single agent or in combination with other cytotoxic agents. No trial to date evaluated its role in patients with primary Hodgkin''''s lymphoma. We therefore developed a three-weekly regimen based on the standard ABVD regimen.
Eligibility
Ages Eligible for Study: 60 Years - 75 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Hodgkin''''s lymphoma (histologically proven)
- Clinical stage IIB (with risk factors bulky mediastinal mass and/or extranodal involvement), III, or IV
- No prior antitumor therapy
- Age 60 to 75 years
- WHO performance status 0-2
- Normal pulmonary function
- Written informed consent
Exclusion Criteria:
- The following histologies are excluded: lymphocyte predominant HD
- Leukocytes < 2,500/microL
- Platelets < 100,000/microL
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00147875
Sven Trelle +49/221/478 Ext. 6128 sven.trelle@uk-koeln.de
Margret Platz +49/221/478 Ext. 3777 margarethe.platz@uk-koeln.de
Margret Platz +49/221/478 Ext. 3777 margarethe.platz@uk-koeln.de
Germany, NRW
University of Cologne, Cologne, NRW, 50924, Germany; Recruiting
Sven Trelle +49/221/478 Ext. 6128 sven.trelle@uk-koeln.de
Sven Trelle, Sub-Investigator
Henning Bredenfeld, Sub-Investigator
Andreas Engert, Principal Investigator
Sven Trelle, Sub-Investigator
Henning Bredenfeld, Sub-Investigator
Andreas Engert, Principal Investigator
Study chairs or principal investigators
Andreas Engert, Principal Investigator, University of Cologne
More Information
Study ID Numbers: PVAG elderly
Last Updated: September 6, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00147875
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 6, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00147875
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13
Resources
- Deltasone (Drug Digest)
- Prednisone Oral (Drug Digest)
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