Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Hodgkin's Lymphoma
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|ClinicalTrials.gov Identifier: NCT00416832|
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : March 26, 2020
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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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: procarbazine hydrochloride Drug: vincristine sulfate Radiation: radiation therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||648 participants|
|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 Start Date :||November 2002|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
- Safety and efficacy
- Reduction of gonadotoxicity
- Quality assurance
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|Ages Eligible for Study:||up to 17 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416832
|Study Chair:||Dieter Koerholz, MD||Martin-Luther-Universität Halle-Wittenberg|
|Responsible Party:||Christine Mauz-Körholz, Prof. Dr. Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg|
|Other Study ID Numbers:||
|First Posted:||December 28, 2006 Key Record Dates|
|Last Update Posted:||March 26, 2020|
|Last Verified:||March 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
stage II childhood Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors