Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352027
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2006-07-13
Brief Title:
Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Stanford V Chemotherapy With Low-Dose Tailored-Field Radiation Therapy for Intermediate Risk Pediatric Hodgkin Lymphoma
Status:
COMPLETED
Status Verified Date:
2023-09
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:
The main purpose of this protocol is to estimate the percentage of patients with intermediate risk Hodgkin lymphoma who will survive free of disease Event-free survival for three years after treatment with multi-agent chemotherapy Stanford V and low-dose tailored-field radiation therapy The hypothesis being studied is that this treatment will result in more than 80 of patients being alive and free of disease three years after starting treatment
Detailed Description:
Treatment Plan Description
Adriamycin 25 mgm2 IV Day 1 of weeks 1 3 5 7 9 11
Vinblastine 6 mgm2 IV Day 1 of weeks 1 3 5 7 9 11
Nitrogen Mustard 6mgm2 IV on Day 1 of weeks 1 5 and 9
Cyclophosphamide 650 mgm2 IV Day 1 of weeks 1 5 9when Nitrogen Mustard was not available due to national shortage
Vincristine 14 mgm2 IV Day 1 of weeks 2 4 6 8 10 12
Bleomycin 5 unitsm2 IV Day 1 of weeks 2 4 6 8 10 12
Etoposide 60 mgm2 IV Days 12 of weeks 3 7 11
Prednisone 40 mgm2day divided in 3 doses PO Every other day of weeks 1-12
G-CSF only as needed in case of severe myelo-suppression requiring treatment delay 5 mcgkg SC Days 3-13 16-26 29-39 42-52 55-65 68-78 as clinically indicated
Prednisone taper is foreseen for the last 2 weeks of therapy Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy 15 Gy for areas achieving a complete response and 255 Gy achieving less than a complete response or patients with bulky mediastinal mass
Adriamycin 25 mgm2 IV Day 1 of weeks 1 3 5 7 9 11
Vinblastine 6 mgm2 IV Day 1 of weeks 1 3 5 7 9 11
Nitrogen Mustard 6mgm2 IV on Day 1 of weeks 1 5 and 9
Cyclophosphamide 650 mgm2 IV Day 1 of weeks 1 5 9when Nitrogen Mustard was not available due to national shortage
Vincristine 14 mgm2 IV Day 1 of weeks 2 4 6 8 10 12
Bleomycin 5 unitsm2 IV Day 1 of weeks 2 4 6 8 10 12
Etoposide 60 mgm2 IV Days 12 of weeks 3 7 11
Prednisone 40 mgm2day divided in 3 doses PO Every other day of weeks 1-12
G-CSF only as needed in case of severe myelo-suppression requiring treatment delay 5 mcgkg SC Days 3-13 16-26 29-39 42-52 55-65 68-78 as clinically indicated
Prednisone taper is foreseen for the last 2 weeks of therapy Patients will be treated with 12 weeks of Stanford V chemotherapy in the schedule outlined above Patients will then receive radiation therapy after completion of 12 weeks of chemotherapy The radiation dose to individual nodal sites will be based on response after 8 weeks of chemotherapy 15 Gy for areas achieving a complete response and 255 Gy achieving less than a complete response or patients with bulky mediastinal mass
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| NCI-2011-01253 | REGISTRY | NCI Clinical Trial Registration Program | None |