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
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
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
NCT ID
NCT00416832
First Posted
December 27, 2006
Last Updated
March 24, 2020
Sponsor
Christine Mauz-Körholz
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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