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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cyclophosphamide
dacarbazine
doxorubicin hydrochloride
etoposide
prednisone
procarbazine hydrochloride
vincristine sulfate
radiation therapy
Sponsored by
Christine Mauz-Körholz
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of classic Hodgkin's lymphoma (HL)

    • Intermediate or advanced disease, including the following stages:

      • Stage I
      • Stage IIA, IIB, IIE, or IIBE
      • Stage IIIA or IIIBE
      • Stage IV

PATIENT CHARACTERISTICS:

  • No other concurrent malignancies
  • No severe concurrent diseases (e.g., immune deficiency syndrome)

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy
  • Pre-phase therapy for large mediastinal tumor allowed

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Safety and efficacy
    Reduction of gonadotoxicity
    Quality assurance

    Secondary Outcome Measures

    Full Information

    First Posted
    December 27, 2006
    Last Updated
    March 24, 2020
    Sponsor
    Christine Mauz-Körholz
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00416832
    Brief Title
    Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Hodgkin's Lymphoma
    Official Title
    Optimising Therapy for Boys With Hodgkin's Lymphoma and Quality Assurance of Therapy for Girls With Hodgkin's Lymphoma Until Start of a New Prospective Trial for Hodgkin's Lymphoma in Childhood and Adolescence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2002 (undefined)
    Primary Completion Date
    December 2005 (Actual)
    Study Completion Date
    December 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Christine Mauz-Körholz

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells. PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with radiation therapy works in treating young patients with Hodgkin's lymphoma.
    Detailed Description
    OBJECTIVES: Determine the safety and efficacy of intensified etoposide administered as a part of OEPA combination chemotherapy (vincristine, etoposide, prednisone, and doxorubicin hydrochloride) in pediatric male patients with intermediate or advanced Hodgkin's lymphoma (HL). Determine the safety and efficacy of COPDIC combination chemotherapy (cyclophosphamide, vincristine, prednisone, and dacarbazine) or COPP combination chemotherapy (cyclophosphamide, vincristine, procarbazine hydrochloride, and prednisone) in reducing gonadotoxicity in male or female patients. Assess quality assurance of these regimens in pediatric female patients with intermediate or advanced HL. OUTLINE: This is a pilot, multicenter study. Patients are stratified according to disease stage (I or IIA vs IIB, IIE, or IIIA vs IIBE, IIIBE, or IV). Stratum 1 (stages I or IIA): Male patients receive vincristine IV on days 1, 8, and 15, etoposide IV over 2 hours on days 3-7, oral prednisone on days 1-15, and doxorubicin hydrochloride IV over 4 hours on days 1 and 15 (OEPA). Female patients receive vincristine, prednisone, and doxorubicin hydrochloride as in male patients and oral procarbazine hydrochloride on days 1-15 (OPPA). Both regimens repeat every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who do not achieve complete remission undergo involved-field radiotherapy beginning 3 weeks after completion of chemotherapy. Stratum 2 (stages IIB, IIE, or IIIA): Male patients receive 2 courses of OEPA as in stratum 1 followed by 2 courses of COPDIC comprising oral prednisone on days 1-15, dacarbazine IV over 30 minutes on days 1-3, and vincristine IV and cyclophosphamide IV over 1 hour on days 1 and 8. Female patients receive 2 courses of OPPA as in stratum 1 followed by COPP comprising oral prednisone and 2 courses of oral procarbazine hydrochloride on days 1-15 and vincristine IV and cyclophosphamide IV over 1 hour on days 1 and 8. Both regimens repeat every 4 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Beginning 3 weeks after completion of chemotherapy, all patients undergo involved-field radiotherapy. Stratum 3 (stages IIBE, IIIBE, or IV): Male patients receive 2 courses of OEPA as in stratum 1 followed by 4 courses of COPDIC as in stratum 2. Female patients receive 2 courses of OPPA as in stratum 1 followed by 4 courses of COPP as in stratum 2. Beginning 3 weeks after completion of chemotherapy, all patients undergo involved-field radiotherapy. PROJECTED ACCRUAL: A total of 648 patients will be 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 II childhood Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma, stage I childhood Hodgkin lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    648 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    cyclophosphamide
    Intervention Type
    Drug
    Intervention Name(s)
    dacarbazine
    Intervention Type
    Drug
    Intervention Name(s)
    doxorubicin hydrochloride
    Intervention Type
    Drug
    Intervention Name(s)
    etoposide
    Intervention Type
    Drug
    Intervention Name(s)
    prednisone
    Intervention Type
    Drug
    Intervention Name(s)
    procarbazine hydrochloride
    Intervention Type
    Drug
    Intervention Name(s)
    vincristine sulfate
    Intervention Type
    Radiation
    Intervention Name(s)
    radiation therapy
    Primary Outcome Measure Information:
    Title
    Safety and efficacy
    Title
    Reduction of gonadotoxicity
    Title
    Quality assurance

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Diagnosis of classic Hodgkin's lymphoma (HL) Intermediate or advanced disease, including the following stages: Stage I Stage IIA, IIB, IIE, or IIBE Stage IIIA or IIIBE Stage IV PATIENT CHARACTERISTICS: No other concurrent malignancies No severe concurrent diseases (e.g., immune deficiency syndrome) PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy Pre-phase therapy for large mediastinal tumor allowed
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dieter Koerholz, MD
    Organizational Affiliation
    Martin-Luther-Universität Halle-Wittenberg
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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