Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005578
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2000-05-02
Brief Title:
Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkins Disease
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study
Status:
COMPLETED
Status Verified Date:
2014-07
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 use different ways to stop tumor cells from dividing so they stop growing or die Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane in treating children who have Hodgkins disease
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane in treating children who have Hodgkins disease
Detailed Description:
OBJECTIVES I Determine the efficacy of doxorubicin bleomycin vincristine etoposide prednisone and cyclophosphamide DBVE-PC with filgrastim G-CSF followed by consolidative radiotherapy in children with advanced stage Hodgkins disease II Tailor therapy based on rapidity of response in order to minimize cumulative drug dosages III Compare the efficacy of dexrazoxane in reducing pulmonary and cardiac toxicity of DBVE-based therapy without compromising response
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms All patients receive 3 courses of chemotherapy consisting of doxorubicin and etoposide on days 0 and 1 bleomycin and vincristine on days 0 and 7 cyclophosphamide on day 0 and prednisone on days 0-6 Filgrastim G-CSF is administered on days 5-6 and 8-19 Each course is 21 days in length Patients assigned to arm I receive only these drugs Patients assigned to arm II receive dexrazoxane on days 0 1 and 7 in addition to therapy as in arm I Patients who exhibit a complete remission CR or provisional CR then receive radiotherapy to the regional field 5 days a week for 28 weeks If the disease is not responsive 2 more courses of chemotherapy are given Patients whose disease remains nonresponsive or progresses go off the study Radiotherapy may follow for others Patients are followed every 3 months for the first year every 4 months for the second year every 6 months for the third year and then annually thereafter
PROJECTED ACCRUAL A total of 277 patients will be accrued for this study within 3 years
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms All patients receive 3 courses of chemotherapy consisting of doxorubicin and etoposide on days 0 and 1 bleomycin and vincristine on days 0 and 7 cyclophosphamide on day 0 and prednisone on days 0-6 Filgrastim G-CSF is administered on days 5-6 and 8-19 Each course is 21 days in length Patients assigned to arm I receive only these drugs Patients assigned to arm II receive dexrazoxane on days 0 1 and 7 in addition to therapy as in arm I Patients who exhibit a complete remission CR or provisional CR then receive radiotherapy to the regional field 5 days a week for 28 weeks If the disease is not responsive 2 more courses of chemotherapy are given Patients whose disease remains nonresponsive or progresses go off the study Radiotherapy may follow for others Patients are followed every 3 months for the first year every 4 months for the second year every 6 months for the third year and then annually thereafter
PROJECTED ACCRUAL A total of 277 patients will be accrued for this study within 3 years
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 |
|---|---|---|---|
| P9425 | OTHER | Pediatric Oncology Group | None |
| COG-9425 | OTHER | None | None |
| CDR0000065359 | OTHER | None | None |