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Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00433459
First Posted: February 12, 2007
Last Update Posted: November 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Deutsche Krebshilfe e.V., Bonn (Germany)
Euronet Worldwide
Information provided by (Responsible Party):
Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to compare how well they work in treating young patients with Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma Drug: cyclophosphamide Drug: dacarbazine Drug: prednisolone Drug: prednisone Drug: procarbazine hydrochloride Drug: vincristine sulfate Radiation: fludeoxyglucose F 18 Radiation: radiation therapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First International Inter-Group Study for Classical Hodgkin's Lymphoma in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ]
  • Progression-free survival [ Time Frame: 5 years ]
  • Toxicity [ Time Frame: 5 years ]
  • Evidence of male infertility score [ Time Frame: 5 years ]
  • Evidence of female infertility score [ Time Frame: 5 years ]
  • Long-term consequences (e.g., premature menopause, secondary cancer) [ Time Frame: 5 years ]

Enrollment: 2134
Study Start Date: January 2007
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: COPP
procarbazine-containing consolidation chemotherapy arm
Drug: cyclophosphamide
drug is used in first line treatment in combination (COPP or COPDAC)
Other Name: CYC
Drug: prednisolone
drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
Drug: prednisone
drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
Drug: procarbazine hydrochloride
drug is used in first line treatment in combination (COPP)
Drug: vincristine sulfate
drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
Other Name: VCR
Radiation: fludeoxyglucose F 18
used as a diagnostic marker for metabolically active tumour at staging and response assessment
Radiation: radiation therapy
part of combination treatment (combined modality between chemo- and radiotherapy)
Other Name: IFRT
Experimental: COPDAC
procarbazine-free consolidation chemotherapy arm
Drug: cyclophosphamide
drug is used in first line treatment in combination (COPP or COPDAC)
Other Name: CYC
Drug: dacarbazine
drug is used in first line treatment in combination (COPDAC)
Other Name: DTIC
Drug: prednisolone
drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
Drug: prednisone
drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
Drug: vincristine sulfate
drug is used in first line treatment in combination (OEPA, COPP or COPDAC)
Other Name: VCR
Radiation: fludeoxyglucose F 18
used as a diagnostic marker for metabolically active tumour at staging and response assessment
Radiation: radiation therapy
part of combination treatment (combined modality between chemo- and radiotherapy)
Other Name: IFRT

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed classical Hodgkin's lymphoma

    • No lymphocyte-predominant Hodgkin's lymphoma
    • Fine-needle biopsy not sufficient
  • No prior treatment for Hodgkin's lymphoma except for recommended pre-phase therapy for a large mediastinal tumor

PATIENT CHARACTERISTICS:

  • No known hypersensitivity or contraindication to study drugs
  • No other current malignancy
  • No severe concurrent disease (e.g., immune deficiency syndrome)
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for up to 1 year after completion of study treatment
  • No known HIV positivity

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior chemotherapy or radiotherapy
  • At least 30 days since prior and no other concurrent investigational drugs or participation in another investigational trial
  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): NCT00433459


Locations
Germany
Universitaetsklinikum Giessen-Marburg
Giessen, Germany, D-35385
United Kingdom
Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Sponsors and Collaborators
Christine Mauz-Körholz
Deutsche Krebshilfe e.V., Bonn (Germany)
Euronet Worldwide
Investigators
Study Chair: Dieter Koerholz, MD Martin-Luther-Universität Halle-Wittenberg
Principal Investigator: W. Hamish Wallace, MD Royal Hospital for Sick Children
Principal Investigator: Judith Landman-Parker, MD Hopital d'Enfants Trousseau
  More Information

Responsible Party: Christine Mauz-Körholz, Prof. Dr. med. Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00433459     History of Changes
Other Study ID Numbers: CDR0000531687
EURONET-PHL-C1
EU-20703
EUDRACT-2006-000995-33
CCLG-HD-2007-10
First Submitted: February 8, 2007
First Posted: February 12, 2007
Last Update Posted: November 18, 2015
Last Verified: November 2015

Keywords provided by Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg:
childhood lymphocyte depletion Hodgkin lymphoma
childhood mixed cellularity Hodgkin lymphoma
childhood nodular sclerosis Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage II childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Prednisone
Vincristine
Prednisolone
Procarbazine
Fluorodeoxyglucose F18
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Tubulin Modulators