Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Elderly Patients With Advanced Stages Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborators:
German Hodgkin's Lymphoma Study Group
Eli Lilly and Company
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00147875
First received: September 2, 2005
Last updated: September 4, 2009
Last verified: September 2009
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PVAG - Phase I/II Dose Finding Trial in Elderly Patients (> 60 Years) With Advanced Stages Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Phase I: Dose-limiting toxicities and dose reductions
  • Phase II: Treatment administration and complete response rate

Secondary Outcome Measures:
  • Toxicities
  • Supportive care (RBCT need, antibiotic need)
  • Early progression rate
  • Overall survival

Enrollment: 60
Study Start Date: March 2004
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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 to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147875

Locations
Germany
University of Cologne
Cologne, NRW, Germany, 50924
Sponsors and Collaborators
University of Cologne
German Hodgkin's Lymphoma Study Group
Eli Lilly and Company
Investigators
Principal Investigator: Andreas Engert University of Cologne
  More Information

No publications provided by University of Cologne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00147875     History of Changes
Other Study ID Numbers: PVAG elderly
Study First Received: September 2, 2005
Last Updated: September 4, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
Lymphoma
Gemcitabine
Advanced stages Hodgkin's lymphoma
Elderly

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Doxorubicin
Liposomal doxorubicin
Prednisone
Vinblastine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on September 18, 2014