Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00433459
First received: February 8, 2007
Last updated: June 16, 2011
Last verified: June 2007
  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
Biological: bleomycin sulfate
Drug: carmustine
Drug: cyclophosphamide
Drug: cytarabine
Drug: dacarbazine
Drug: doxorubicin hydrochloride
Drug: etoposide
Drug: etoposide phosphate
Drug: ifosfamide
Drug: melphalan
Drug: prednisolone
Drug: prednisone
Drug: procarbazine hydrochloride
Drug: vinblastine sulfate
Drug: vincristine sulfate
Procedure: autologous hematopoietic stem cell transplantation
Radiation: fludeoxyglucose F 18
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Evidence of male infertility score [ Designated as safety issue: No ]
  • Evidence of female sexual functioning score [ Designated as safety issue: No ]
  • Long-term consequences (e.g., premature menopause, secondary cancer) [ Designated as safety issue: No ]

Estimated Enrollment: 2150
Study Start Date: January 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433459

Locations
Germany
Universitaetsklinikum Halle Recruiting
Halle, Germany, D-06097
Contact: Dieter Koerholz, MD    49-345-557-2387      
United Kingdom
Royal Hospital for Sick Children Recruiting
Edinburgh, Scotland, United Kingdom, EH9 1LF
Contact: W. Hamish Wallace, MD    44-131-536-0426      
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Investigators
Study Chair: Dieter Koerholz, MD Martin-Luther-Universität Halle-Wittenberg
Investigator: W. Hamish Wallace, MD Royal Hospital for Sick Children
Investigator: Judith Landman-Parker, MD Hopital d'Enfants Trousseau
  More Information

Additional Information:
No publications provided

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
Study First Received: February 8, 2007
Last Updated: June 16, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
Bleomycin
Doxorubicin
Etoposide phosphate
Isophosphamide mustard
Carmustine
Cyclophosphamide
Cytarabine
Dacarbazine
Etoposide
Ifosfamide
Melphalan
Prednisolone
Methylprednisolone Hemisuccinate
Prednisone
Procarbazine
Vinblastine
Vincristine
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate

ClinicalTrials.gov processed this record on April 17, 2014