Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398554
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2006-11-09
Brief Title:
Combination Chemotherapy in Treating Young Male Patients With Hodgkins Lymphoma
Sponsor:
Christine Mauz-Körholz
Organization:
Martin-Luther-Universität Halle-Wittenberg
Study Overview
Official Title:
Pilot Study for Therapy Optimising for Hodgkins Lymphoma in Childhood and Adolescence Optimising Therapy for Boys With Hodgkins Lymphoma in Intermediate and Advanced Stages Safety and Efficacy Study for Drug Combination VECOPA
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 Giving combination chemotherapy may kill more cancer cells
PURPOSE This phase II trial is studying the side effects and how well combination chemotherapy works in treating young male patients with Hodgkins lymphoma
PURPOSE This phase II trial is studying the side effects and how well combination chemotherapy works in treating young male patients with Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine the safety and efficacy of combination chemotherapy comprising vincristine etoposide cyclophosphamide vinblastine prednisone and doxorubicin hydrochloride VECOPA in pediatric male patients with previously untreated stage II-IV classic Hodgkins lymphoma
Compare the effects of VECOPA vs cyclophosphamide vincristine procarbazine hydrochloride and prednisone COPP in these patients
OUTLINE This is a pilot multicenter study Patients are stratified according to disease stage IABE IIAE IIB or IIIA vs IIBE IIIABE IIIB or IVAB
Stratum 1 stages IABE IIAE IIB or IIIA Patients receive oral prednisone on days 1-15 vincristine IV on days 1 8 and 15 doxorubicin hydrochloride IV over 4 hours on days 1 and 15 and etoposide IV over 2 hours on days 2-6 OEPA Treatment repeats every 4 weeks for 2 courses Beginning at week 9 patients receive VECOPA chemotherapy comprising oral prednisone on days 1-14 and 21-34 etoposide IV over 2 hours on days 1-3 doxorubicin hydrochloride IV over 2 hours on day 21 vinblastine IV and cyclophosphamide IV over 1 hour on days 1 and 21 and vincristine IV on days 8 and 29 Patients then undergo radiotherapy
Stratum 2 stages IIBE IIIABE IIIB or IVAB Patients receive 2 courses of OEPA as in stratum 1 followed by 2 courses of VECOPA 6-week courses Patients then undergo radiotherapy
After completion of study treatment patients are followed periodically for at least 6 years
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Determine the safety and efficacy of combination chemotherapy comprising vincristine etoposide cyclophosphamide vinblastine prednisone and doxorubicin hydrochloride VECOPA in pediatric male patients with previously untreated stage II-IV classic Hodgkins lymphoma
Compare the effects of VECOPA vs cyclophosphamide vincristine procarbazine hydrochloride and prednisone COPP in these patients
OUTLINE This is a pilot multicenter study Patients are stratified according to disease stage IABE IIAE IIB or IIIA vs IIBE IIIABE IIIB or IVAB
Stratum 1 stages IABE IIAE IIB or IIIA Patients receive oral prednisone on days 1-15 vincristine IV on days 1 8 and 15 doxorubicin hydrochloride IV over 4 hours on days 1 and 15 and etoposide IV over 2 hours on days 2-6 OEPA Treatment repeats every 4 weeks for 2 courses Beginning at week 9 patients receive VECOPA chemotherapy comprising oral prednisone on days 1-14 and 21-34 etoposide IV over 2 hours on days 1-3 doxorubicin hydrochloride IV over 2 hours on day 21 vinblastine IV and cyclophosphamide IV over 1 hour on days 1 and 21 and vincristine IV on days 8 and 29 Patients then undergo radiotherapy
Stratum 2 stages IIBE IIIABE IIIB or IVAB Patients receive 2 courses of OEPA as in stratum 1 followed by 2 courses of VECOPA 6-week courses Patients then undergo radiotherapy
After completion of study treatment patients are followed periodically for at least 6 years
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| EUDRACT-2004-005244-28 | None | None | None |
| GPOH-HD-2002-PILOT-VECOPA | None | None | None |
| EU-20652 | None | None | None |