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

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bleomycin sulfate
chlorambucil
dacarbazine
doxorubicin hydrochloride
prednisolone
procarbazine hydrochloride
vinblastine sulfate
vincristine 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 - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed childhood Hodgkin's lymphoma by lymph node biopsy

    • Any stage disease
    • Patients with bilateral upper cervical disease with no evidence of supraclavicular, thoracic inlet, or Waldeyers ring involvement are treated as having stage I disease

PATIENT CHARACTERISTICS:

  • Platelet count > 100,000/mm^3
  • Absolute neutrophil count > 1,000/mm^3

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
    NCT00416377
    Brief Title
    Radiation Therapy or Combination Chemotherapy in Treating Young Patients With Hodgkin's Lymphoma
    Official Title
    Hodgkin's 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: Radiation therapy uses high-energy x-rays to kill cancer cells. 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. PURPOSE: This clinical trial is studying how well radiation therapy or combination chemotherapy work in treating young patients with Hodgkin's lymphoma.
    Detailed Description
    OBJECTIVES: Maintain the present satisfactory results of patients treated on protocol UKCCSG-HD-8201 in pediatric patients with stage I-III Hodgkin's lymphoma treated with radiotherapy or combination chemotherapy comprising chlorambucil, procarbazine hydrochloride, prednisolone, vinblastine followed by doxorubicin hydrochloride, bleomycin, vincristine, and dacarbazine. Determine, by comparison with UKCCSG-HD-8201, if mediastinal irradiation can be safely omitted from the management of pediatric patients with Hodgkin's lymphoma and bulky mediastinal disease. Determine if gallium scanning of the mediastinum after chemotherapy will identify patients with residual active mediastinal disease. Improve disease control in patients with stage IV Hodgkin's lymphoma and slow responders by intensifying treatment to patients who fail to achieve complete remission after 4 courses of chlorambucil, vinblastine, procarbazine hydrochloride, and prednisone. OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease (I vs II-IV). Stage I: Patients undergo involved-field radiotherapy. Stage II-IV: CHLVPP chemotherapy: Patients receive CHLVPP chemotherapy comprising oral chlorambucil, oral procarbazine hydrochloride, and oral prednisolone on days 1-14 and vinblastine IV on days 1-8. Treatment repeats every 28 days for 2 courses. Patients achieving complete resolution (CR) of measurable disease receive an additional 4 courses of CHLVPP. Patients with no response or progressive disease proceed to ABVD chemotherapy. Patients with shrinkage of measurable disease to < 50% original dimensions (GPR) receive 2 additional courses of CHLVPP. Patients achieving CR or GPR after completion of 2 additional courses of CHLVPP receive 4 more courses of CHLVPP. Patients achieving shrinkage of measurable disease to ≥ 50% of original dimension (PR) after 2 additional courses of CHLVPP OR patients not achieving CR after a total of 8 courses of CHLVPP proceed to ABVD chemotherapy. ABVD chemotherapy: Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV over 4 hours and bleomycin IV, vincristine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Mediastinal mass: Patients receive chemotherapy as per stages II-IV. Patients presenting with airway or superior vena cava obstruction may also undergo radiotherapy. Patients achieving CR after completion of chemotherapy receive no further treatment. Patients achieving GPR or PR after completion of chemotherapy undergo gallium scan and CT scan of thorax with or without biopsy at the investigator's discretion. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 353 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
    353 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    bleomycin sulfate
    Intervention Type
    Drug
    Intervention Name(s)
    chlorambucil
    Intervention Type
    Drug
    Intervention Name(s)
    dacarbazine
    Intervention Type
    Drug
    Intervention Name(s)
    doxorubicin hydrochloride
    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
    Drug
    Intervention Name(s)
    vincristine sulfate
    Intervention Type
    Radiation
    Intervention Name(s)
    radiation therapy

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically confirmed childhood Hodgkin's lymphoma by lymph node biopsy Any stage disease Patients with bilateral upper cervical disease with no evidence of supraclavicular, thoracic inlet, or Waldeyers ring involvement are treated as having stage I disease PATIENT CHARACTERISTICS: Platelet count > 100,000/mm^3 Absolute neutrophil count > 1,000/mm^3 PRIOR CONCURRENT THERAPY: Not specified
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ann Barrett
    Organizational Affiliation
    University of Glasgow
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Judith E. Kingston, MD
    Organizational Affiliation
    St. Bartholomew's Hospital
    First Name & Middle Initial & Last Name & Degree
    John Martin, MD
    Organizational Affiliation
    Royal Liverpool Children's Hospital, Alder Hey

    12. IPD Sharing Statement

    Learn more about this trial

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

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