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

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ClinicalTrials.gov Identifier: NCT00147875
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : September 7, 2009
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hodgkin's Disease Drug: Prednisone Drug: Vinblastine Drug: Doxorubicin (Adriamycin) Drug: Gemcitabine Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2004
Primary Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. Toxicities
  2. Supportive care (RBCT need, antibiotic need)
  3. Early progression rate
  4. Overall survival

Eligibility Criteria

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): 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

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
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: September 7, 2009
Last Verified: September 2009

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
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists