PVAG-14 Pilot for Intermediate Stages Hodgkin Lymphoma

This study has been terminated.
(lower recruitment rates as expected)
Sponsor:
Information provided by:
University of Cologne
ClinicalTrials.gov Identifier:
NCT00512980
First received: August 7, 2007
Last updated: May 12, 2011
Last verified: May 2011
  Purpose

A randomized phase II study of prednisone, vinblastine, doxorubicin, and gemcitabine in patients with intermediate stage Hodgkin's lymphoma


Condition Intervention Phase
Hodgkin Lymphoma
Drug: prednisone
Drug: vinblastine
Drug: doxorubicin
Drug: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Prednisone, Vinblastine, Doxorubicin, and Gemcitabine in Patients With Intermediate Stage Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Study Start Date: August 2008
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: prednisone Drug: vinblastine Drug: doxorubicin Drug: gemcitabine
Active Comparator: 2 Drug: prednisone Drug: vinblastine Drug: doxorubicin Drug: gemcitabine

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of Hodgkin's lymphoma
  2. Stage

    • Clinical Stage IA, IB, IIA with at least one of the risk factors a-d given below
    • Clinical Stage IIB with one or both risk factors c-d given below risk factors:

      • Large mediastinal mass (≥ 1/3 of the greatest thorax diameter as measured by chest x-ray)
      • Extranodal involvement
      • High erythrocyte sedimentation rate (≥ 50 mm/h in patients without B-symptoms, ≥ 30 mm/h in patients with B-symptoms)
      • Three or more involved lymph node areas
  3. No prior therapy for Hodgkin's lymphoma (exception: pre-phase treatment with corticosteroids and vinca-alkaloids for a maximum of seven days may not preclude trial participation if clinically indicated and all staging examinations have been performed; all forms of prior radiotherapy preclude trial participation)
  4. Age: 18-60 years
  5. Signed informed consent with understanding of the study procedures and the investigational nature of the study
  6. Patient agrees that personal data and tissue samples are provided to the GHSG (protection of privacy as defined by law will be ensured)
  7. Life expectancy > 3 months according to investigator judgement.

Exclusion Criteria:

  1. Incomplete diagnosis of stage of disease
  2. Prior or concurrent disease which prevents treatment according to protocol In particular the following contraindications:

    • Chronic obstructive pulmonary disease with global insufficiency
    • Symptomatic coronary heart disease
    • Cardiomyopathy or cardiac insufficiency (NYHA value of EF < 50% or FS < 25%)
    • Serious uncontrolled hypertension
    • Uncontrollable infection
    • Leucocyte concentration < 3.000/mm3 or thrombocyte concentration < 100.000/mm3
    • Creatinin clearance < 60 ml/min
    • Bilirubin > 2 mg/dl or GPT > 100 U/l or GOT > 100 U/I (exception: elevated values of Hodgkin`s disease liver involvement)
    • HIV-Infection according to HIV test
    • Chronic or acute Hepatitis
  3. HD as composite lymphoma
  4. Prior chemotherapy or radiation
  5. Malignant disease within the last 5 years (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma TNMpT1)
  6. Pregnancy, lactation, positive pregnancy test
  7. Refusal to use effective contraception
  8. WHO performance index > 2
  9. Long-term ingestion of corticosteroids (e.g. for chronic polyarthritis) or antineoplastic drugs (e.g. methotrexate)
  10. Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes correspondingly
  11. Non compliance: Refusal of blood products during treatment, epilepsy, drug dependency, change of residence abroad, prior cerebral injury or similar circumstances which appear to make protocol treatment or long-term follow-up impossible
  12. Antiepileptic treatment
  13. General intolerance of any protocol medication
  14. Any contraindication for study medication according to the summaries of product information
  15. Simultaneous participation in another clinical
  16. Institutionalization by law
  17. Relation of dependence with the sponsor`s representative / trialist
  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: NCT00512980

Locations
Germany
University of Cologne
Cologne, Germany
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Andreas Engert, Prof University of Cologne
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00512980     History of Changes
Other Study ID Numbers: PVAG-14 pilot
Study First Received: August 7, 2007
Last Updated: May 12, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Cologne:
intermediate stages

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Liposomal doxorubicin
Gemcitabine
Prednisone
Vinblastine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on August 25, 2014