Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004010
Status:
COMPLETED
Last Update Posted:
2014-02-26
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy and Radiation Therapy in Treating Children With Previously Untreated Stage II Stage III or Stage IV Hodgkins Disease
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
Pilot Study for the Treatment of Children With Newly Diagnosed Advanced Stage Hodgkins Disease Upfront Dose Intensive Chemotherapy
Status:
COMPLETED
Status Verified Date:
2014-02
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells Radiation therapy uses high-energy x-rays to damage cancer cells Giving radiation therapy after chemotherapy may be an effective treatment for Hodgkins disease
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating children who have previously untreated stage II stage III or stage IV Hodgkins disease
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating children who have previously untreated stage II stage III or stage IV Hodgkins disease
Detailed Description:
OBJECTIVES I Determine the feasibility and toxicity of bleomycin etoposide doxorubicin cyclophosphamide vincristine procarbazine and prednisone BEACOPP induction in pediatric patients with previously untreated stage II stage III or stage IV Hodgkins disease II Determine rates of complete response and rapid early partial response defined as greater than 70 reduction in the size of a bulky mediastinal mass or nodal aggregate and a negative gallium scan in these patients treated with 4 courses of BEACOPP III Determine whether thallium scans effectively measure response to therapy in these patients treated with this regimen IV Evaluate the expression of markers of apoptosis in tumor samples from these patients at diagnosis and at time of relapse and correlate expression of these markers with response to therapy and overall outcome V Determine the utility of seven molecular genetic markers as surrogate markers of genotoxic damage caused by this regimen in these patients VI Estimate the incidence of therapy related late effects including second malignant neoplasms sterility cardiac dysfunction pulmonary restrictive disease growth abnormalities and thyroid disease in these patients
OUTLINE Induction On day 0 patients receive cyclophosphamide IV over 30 minutes doxorubicin IV over 15-30 minutes etoposide IV over 1 hour oral prednisone every 12 hours and oral procarbazine On days 1 and 2 patients receive etoposide IV over 1 hour oral prednisone every 12 hours and oral procarbazine On days 3-6 patients receive oral prednisone every 12 hours and oral procarbazine On day 7 patients receive vincristine IV bleomycin IV over 5 minutes and oral prednisone every 12 hours On days 8-13 patients receive oral prednisone every 12 hours Beginning on day 8 patients receive filgrastim G-CSF subcutaneously until absolute neutrophil counts recover Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Consolidation therapy begins on week 12 or when blood counts recover Consolidation for rapid early responders patients with complete response CR or rapid early partial response PR-1 to induction therapy Females - Patients receive vincristine IV cyclophosphamide IV over 30 minutes oral prednisone every 12 hours and oral procarbazine on day 0 On days 1-6 patients receive oral prednisone every 12 hours and oral procarbazine On day 7 patients receive vinblastine IV bleomycin IV over 5 minutes doxorubicin IV over 15-30 minutes and oral prednisone every 12 hours On days 8-13 patients receive oral prednisone every 12 hours Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity Males - Patients receive doxorubicin IV over 15-30 minutes bleomycin IV over 5 minutes vinblastine IV and dacarbazine IV on days 0 and 14 Treatment repeats every 28 days for a total of 2 courses in the absence of disease progression or unacceptable toxicity Beginning 3 weeks after completion of chemotherapy male patients with CR or PR-1 receive radiotherapy 5 days per week to areas of initial disease involvement total duration of radiotherapy is dependent on initial extent of disease Consolidation for slow early responders Patients with slow partial response PR-2 or stable disease SD after 4 courses of induction therapy receive 4 additional courses of induction therapy in the absence of disease progression or unacceptable toxicity Beginning on day 8 patients receive G-CSF subcutaneously until blood counts recover Patients should be off G-CSF for more than 24 hours prior to the next course of chemotherapy Beginning 3 weeks after completion of chemotherapy male and female patients with PR-2 or SD receive radiotherapy 5 days per week to areas of initial disease involvement total duration of radiotherapy is dependent on initial extent of disease Patients are followed every 3 months for 2 years every 6 months for 1 year annually for 2 years and then at years 10 and 20
PROJECTED ACCRUAL Approximately 25-50 patients will be accrued for this study
OUTLINE Induction On day 0 patients receive cyclophosphamide IV over 30 minutes doxorubicin IV over 15-30 minutes etoposide IV over 1 hour oral prednisone every 12 hours and oral procarbazine On days 1 and 2 patients receive etoposide IV over 1 hour oral prednisone every 12 hours and oral procarbazine On days 3-6 patients receive oral prednisone every 12 hours and oral procarbazine On day 7 patients receive vincristine IV bleomycin IV over 5 minutes and oral prednisone every 12 hours On days 8-13 patients receive oral prednisone every 12 hours Beginning on day 8 patients receive filgrastim G-CSF subcutaneously until absolute neutrophil counts recover Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Consolidation therapy begins on week 12 or when blood counts recover Consolidation for rapid early responders patients with complete response CR or rapid early partial response PR-1 to induction therapy Females - Patients receive vincristine IV cyclophosphamide IV over 30 minutes oral prednisone every 12 hours and oral procarbazine on day 0 On days 1-6 patients receive oral prednisone every 12 hours and oral procarbazine On day 7 patients receive vinblastine IV bleomycin IV over 5 minutes doxorubicin IV over 15-30 minutes and oral prednisone every 12 hours On days 8-13 patients receive oral prednisone every 12 hours Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity Males - Patients receive doxorubicin IV over 15-30 minutes bleomycin IV over 5 minutes vinblastine IV and dacarbazine IV on days 0 and 14 Treatment repeats every 28 days for a total of 2 courses in the absence of disease progression or unacceptable toxicity Beginning 3 weeks after completion of chemotherapy male patients with CR or PR-1 receive radiotherapy 5 days per week to areas of initial disease involvement total duration of radiotherapy is dependent on initial extent of disease Consolidation for slow early responders Patients with slow partial response PR-2 or stable disease SD after 4 courses of induction therapy receive 4 additional courses of induction therapy in the absence of disease progression or unacceptable toxicity Beginning on day 8 patients receive G-CSF subcutaneously until blood counts recover Patients should be off G-CSF for more than 24 hours prior to the next course of chemotherapy Beginning 3 weeks after completion of chemotherapy male and female patients with PR-2 or SD receive radiotherapy 5 days per week to areas of initial disease involvement total duration of radiotherapy is dependent on initial extent of disease Patients are followed every 3 months for 2 years every 6 months for 1 year annually for 2 years and then at years 10 and 20
PROJECTED ACCRUAL Approximately 25-50 patients will be accrued for this study
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 |
|---|---|---|---|
| CDR0000067222 | OTHER | ClinicalTrialsgov | None |
| COG-59704 | OTHER | None | None |