Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416832
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2006-12-27
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Hodgkins Lymphoma
Sponsor:
Christine Mauz-Körholz
Organization:
Martin-Luther-Universität Halle-Wittenberg
Study Overview
Official Title:
Optimising Therapy for Boys With Hodgkins Lymphoma and Quality Assurance of Therapy for Girls With Hodgkins Lymphoma Until Start of a New Prospective Trial for Hodgkins Lymphoma in Childhood and Adolescence
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Hodgkins lymphoma
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 Hodgkins 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 Hodgkins 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
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 Hodgkins 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20651 | None | None | None |
| GPOH-HD-2002 | None | None | None |