Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT00352027
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2006-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Chemotherapy With Low-Dose Radiation for Pediatric Hodgkin Lymphoma
Sponsor:
St. Jude Children's Research Hospital
Organization:
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 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11
Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11
Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9
Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage)
Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12
Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12
Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11
Prednisone\* 40 mg/m2/day 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 mcg/kg 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 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.
Adriamycin 25 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11
Vinblastine 6 mg/m2 IV Day 1 of weeks 1, 3, 5, 7, 9, 11
Nitrogen Mustard 6mg/m2 IV on Day 1 of weeks 1, 5, and 9
Cyclophosphamide 650 mg/m2 IV Day 1 of weeks 1, 5, 9(when Nitrogen Mustard was not available due to national shortage)
Vincristine 1.4 mg/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12
Bleomycin 5 units/m2 IV Day 1 of weeks 2, 4, 6, 8, 10, 12
Etoposide 60 mg/m2 IV Days 1,2 of weeks 3, 7, 11
Prednisone\* 40 mg/m2/day 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 mcg/kg 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 25.5 Gy achieving less than a complete response, or patients with bulky mediastinal mass.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2011-01253 | REGISTRY | NCI Clinical Trial Registration Program | View |