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Combination Chemotherapy and/or Radiation Therapy in Treating Young Patients With Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
chlorambucil
prednisolone
procarbazine hydrochloride
vinblastine sulfate
radiation therapy
Sponsored by
Children's Cancer and Leukaemia Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma

Eligibility Criteria

undefined - 14 Years (Child)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Biopsy proven Hodgkin's lymphoma

    • Any stage allowed

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 27, 2006
    Last Updated
    August 1, 2013
    Sponsor
    Children's Cancer and Leukaemia Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00417014
    Brief Title
    Combination Chemotherapy and/or Radiation Therapy in Treating Young Patients With Hodgkin's Lymphoma
    Official Title
    Hodgkins Disease Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2006
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Children's Cancer and Leukaemia Group

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Drugs used in chemotherapy, such as chlorambucil, vinblastine, procarbazine, and prednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more cancer cells. PURPOSE: This clinical trial is studying how well giving combination chemotherapy and/or radiation therapy works in treating young patients with Hodgkin's lymphoma.
    Detailed Description
    OBJECTIVES: Establish a uniform practice for the management of children with Hodgkin's lymphoma. Document the long-term side effects of such management. Establish whether or not children can be safely managed without staging laparotomy and splenectomy. Establish whether or not chlorambucil, vinblastine, procarbazine hydrochloride, and prednisolone (CLVPP) is an effective alternative to mechlorethamine, vincristine, procarbazine hydrochloride, and prednisone (MOPP) chemotherapy. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 3 treatment regimens according to disease stage and presence of bulky mediastinal disease. Involved-field radiotherapy (for patients with stage IA [nodal] disease): Patients undergo involved-field radiotherapy 5 days a week for 4 weeks. CLVPP chemotherapy (for patients with all other stages of disease AND no bulky mediastinal disease): Patients receive CLVPP chemotherapy comprising oral chlorambucil, oral procarbazine hydrochloride, and oral prednisolone on days 1-14 and vinblastine IV on days 1 and 8. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. CLVPP chemotherapy and radiotherapy (for patients with all other stages of disease AND bulky mediastinal disease): Patients receive CLVPP chemotherapy as above. Patients then undergo radiotherapy to the mediastinum beginning 2 weeks after completing the last course of CLVPP chemotherapy. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 358 patients were accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma
    Keywords
    stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, recurrent/refractory childhood Hodgkin lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Masking
    None (Open Label)
    Enrollment
    358 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    chlorambucil
    Intervention Type
    Drug
    Intervention Name(s)
    prednisolone
    Intervention Type
    Drug
    Intervention Name(s)
    procarbazine hydrochloride
    Intervention Type
    Drug
    Intervention Name(s)
    vinblastine sulfate
    Intervention Type
    Radiation
    Intervention Name(s)
    radiation therapy

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Biopsy proven Hodgkin's lymphoma Any stage allowed PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Martin, MD
    Organizational Affiliation
    Royal Liverpool Children's Hospital, Alder Hey
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    A. Barratt, MD
    Organizational Affiliation
    Royal Marsden NHS Foundation Trust

    12. IPD Sharing Statement

    Learn more about this trial

    Combination Chemotherapy and/or Radiation Therapy in Treating Young Patients With Hodgkin's Lymphoma

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