Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145600
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2005-09-02
Brief Title:
Therapy for Pediatric Hodgkin Lymphoma
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Risk-Adapted Therapy for Pediatric Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2022-09
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:
With the success of current chemotherapy for Hodgkins disease the goal of this protocol is to maintain the currently successful cure rate and reduce treatment related side effects and long term toxicity The main purpose of this study is to estimate the event free survival of patients treated with risk-adapted therapy compared to historical controls
Detailed Description:
This study will evaluate the following objectives
Primary Objectives
1 To evaluate the efficacy of 4 cycles of VAMP chemotherapy alone in patients with favorable risk Hodgkins disease who achieve a complete response after 2 cycles of VAMP chemotherapy
2 To evaluate the efficacy of 4 cycles VAMP chemotherapy plus low dose RT in patients with favorable risk Hodgkins disease who achieve a partial response after 2 cycles of VAMP chemotherapy
3 To evaluate the efficacy of 2 alternating cycles of VAMPCOP chemotherapy total 4 cycles of chemotherapy plus low-dose involved-field RT in children with intermediate risk Hodgkins disease
4 To evaluate the efficacy of 12 weeks of Stanford V chemotherapy plus low-dose involved-field RT in children with unfavorable risk Hodgkins disease
Secondary Objectives
1 To evaluate patient quality of life during and after treatment from the patient and parent perspective
2 To compare patient and parental ratings of treatment-related symptoms and patient physical psychological social and cognitive functioning before the first treatment T1 - baseline after Cycle 2 or after 8 weeks of Stanford V T2 - Evaluate Response after cycle 4 or after 12 weeks of Stanford V and before or on the first day of radiation as applicable T3 at the conclusion of radiation or within a few days following the end of radiation as applicable T4 and at 3 to 6 months after completion of therapy follow-up evaluation T5
Primary Objectives
1 To evaluate the efficacy of 4 cycles of VAMP chemotherapy alone in patients with favorable risk Hodgkins disease who achieve a complete response after 2 cycles of VAMP chemotherapy
2 To evaluate the efficacy of 4 cycles VAMP chemotherapy plus low dose RT in patients with favorable risk Hodgkins disease who achieve a partial response after 2 cycles of VAMP chemotherapy
3 To evaluate the efficacy of 2 alternating cycles of VAMPCOP chemotherapy total 4 cycles of chemotherapy plus low-dose involved-field RT in children with intermediate risk Hodgkins disease
4 To evaluate the efficacy of 12 weeks of Stanford V chemotherapy plus low-dose involved-field RT in children with unfavorable risk Hodgkins disease
Secondary Objectives
1 To evaluate patient quality of life during and after treatment from the patient and parent perspective
2 To compare patient and parental ratings of treatment-related symptoms and patient physical psychological social and cognitive functioning before the first treatment T1 - baseline after Cycle 2 or after 8 weeks of Stanford V T2 - Evaluate Response after cycle 4 or after 12 weeks of Stanford V and before or on the first day of radiation as applicable T3 at the conclusion of radiation or within a few days following the end of radiation as applicable T4 and at 3 to 6 months after completion of therapy follow-up evaluation T5
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-2011-03721 | REGISTRY | NCI Clinical Trial Registration Program | None |