Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025259
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2001-10-11
Brief Title:
Chemotherapy With or Without Additional Chemotherapy andor Radiation Therapy in Treating Children With Newly Diagnosed Hodgkins Disease
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease
Status:
COMPLETED
Status Verified Date:
2016-05
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:
This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkins disease Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Giving the drugs in different combinations may kill more cancer cells Radiation therapy uses high-energy x-rays to damage cancer cells It is not yet known if chemotherapy is more effective with or without additional chemotherapy andor radiation therapy in treating Hodgkins disease
Detailed Description:
OBJECTIVES
I To compare response-based therapy to standard therapy for intermediate risk Hodgkin disease
II To determine whether involved field radiation therapy IFRT can be eliminated based upon early and complete response to multiagent chemotherapy
III To determine whether the addition of an additional two cycles of chemotherapy DECA can improve outcome in those with a slow early response to standard chemotherapy
IV To prospectively collect information on the individual prognostic significance of the following presenting factors erythrocyte sedimentation rate circulating levels of IL-10 each of the B symptoms - fever night sweats weight loss nodal aggregate 6 cm large mediastinal mass 13 thoracic diameter and number of involved nodal sites histology albumin blood counts sex and age
V To study the reliability and utility of 18F -Fluorodeoxyglucose FDG Imaging PET scans as an imaging modality in Hodgkin disease
VI To determine the frequency and severity of late effects of therapy including thyroid dysfunction infertility cardiotoxicity pulmonary toxicity and second malignant neoplasms
VII To serve as the therapeutic companion to biology studies in Hodgkin disease and correlate those results with response to therapy event free-survival and overall survival
OUTLINE This is a randomized multicenter study
ARM I ALL PATIENTS-OFF THERAPY BEFORE CALLBACK-INDUCTION CHEMOTHERAPY ABVE-PC Patients receive doxorubicin intravenously IV over 10-30 minutes on days 1-2 bleomycin sulfate IV over 10-20 minutes or subcutaneously SC and vincristine IV on days 1 and 8 etoposide IV over 1 hour on days 1-3 oral prednisone 2 or 3 times daily on days 1-7 and cyclophosphamide IV over 1 hour on day 1 Patients receive filgrastim G-CSF SC beginning on day 2 and continuing until blood counts recover G-CSF is held on day 8 Treatment repeats every 21 days for 2 courses in the absence of progressive disease At the end of initial chemotherapy patients undergo evaluation for response Patients with less than 60 disease reduction are considered to have slow early response SER Patients with 60 or more disease reduction are considered to have rapid early response RER
RER Patients receive 2 additional courses of ABVE-PC chemotherapy After completion of treatment patients are randomized to 1 of 4 treatment arms
ARM II Patients with sustained complete response CR undergo involved field radiation therapy IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week
ARM III Patients with sustained CR receive no further treatment
ARM IV Patients with very good partial response VGPR partial response PR or stable disease SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week
ARM V Patients with progressive disease are taken off therapy and treated their physicians discretion
SER Patients are randomized to 1 of 2 treatment arms
ARM VI Patients receive dexamethasone IV over 15 minutes etoposide IV over 3 hours cytarabine IV over 3 hours on days 1-2 and receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1 2 and 3 Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 and G-CSF SC beginning on day 3 and continuing until blood counts recover Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity After these 2 courses patients then receive 2 additional courses of ABVE-PC chemotherapy
ARM VII Patients receive 2 courses of ABVE-PC chemotherapy
In both SER arms patients with sustained CR or PR undergo IFRT approximately 3 weeks after the last course of chemotherapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
I To compare response-based therapy to standard therapy for intermediate risk Hodgkin disease
II To determine whether involved field radiation therapy IFRT can be eliminated based upon early and complete response to multiagent chemotherapy
III To determine whether the addition of an additional two cycles of chemotherapy DECA can improve outcome in those with a slow early response to standard chemotherapy
IV To prospectively collect information on the individual prognostic significance of the following presenting factors erythrocyte sedimentation rate circulating levels of IL-10 each of the B symptoms - fever night sweats weight loss nodal aggregate 6 cm large mediastinal mass 13 thoracic diameter and number of involved nodal sites histology albumin blood counts sex and age
V To study the reliability and utility of 18F -Fluorodeoxyglucose FDG Imaging PET scans as an imaging modality in Hodgkin disease
VI To determine the frequency and severity of late effects of therapy including thyroid dysfunction infertility cardiotoxicity pulmonary toxicity and second malignant neoplasms
VII To serve as the therapeutic companion to biology studies in Hodgkin disease and correlate those results with response to therapy event free-survival and overall survival
OUTLINE This is a randomized multicenter study
ARM I ALL PATIENTS-OFF THERAPY BEFORE CALLBACK-INDUCTION CHEMOTHERAPY ABVE-PC Patients receive doxorubicin intravenously IV over 10-30 minutes on days 1-2 bleomycin sulfate IV over 10-20 minutes or subcutaneously SC and vincristine IV on days 1 and 8 etoposide IV over 1 hour on days 1-3 oral prednisone 2 or 3 times daily on days 1-7 and cyclophosphamide IV over 1 hour on day 1 Patients receive filgrastim G-CSF SC beginning on day 2 and continuing until blood counts recover G-CSF is held on day 8 Treatment repeats every 21 days for 2 courses in the absence of progressive disease At the end of initial chemotherapy patients undergo evaluation for response Patients with less than 60 disease reduction are considered to have slow early response SER Patients with 60 or more disease reduction are considered to have rapid early response RER
RER Patients receive 2 additional courses of ABVE-PC chemotherapy After completion of treatment patients are randomized to 1 of 4 treatment arms
ARM II Patients with sustained complete response CR undergo involved field radiation therapy IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week
ARM III Patients with sustained CR receive no further treatment
ARM IV Patients with very good partial response VGPR partial response PR or stable disease SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week
ARM V Patients with progressive disease are taken off therapy and treated their physicians discretion
SER Patients are randomized to 1 of 2 treatment arms
ARM VI Patients receive dexamethasone IV over 15 minutes etoposide IV over 3 hours cytarabine IV over 3 hours on days 1-2 and receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1 2 and 3 Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 and G-CSF SC beginning on day 3 and continuing until blood counts recover Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity After these 2 courses patients then receive 2 additional courses of ABVE-PC chemotherapy
ARM VII Patients receive 2 courses of ABVE-PC chemotherapy
In both SER arms patients with sustained CR or PR undergo IFRT approximately 3 weeks after the last course of chemotherapy
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
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 |
|---|---|---|---|
| U10CA098543 | NIH | CTEP | httpsreporternihgovquickSearchU10CA098543 |
| NCI-2011-02069 | REGISTRY | None | None |
| CDR0000068943 | None | None | None |
| COG-AHOD0031 | None | None | None |
| AHOD0031 | OTHER | None | None |
| AHOD0031 | OTHER | None | None |