Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025064
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy With or Without Radiation Therapy and Peripheral Stem Cell Transplant in Treating Children With Hodgkins Lymphoma
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Protocol For The Treatment Of Children And Adolescents With Hodgkins Disease
Status:
UNKNOWN
Status Verified Date:
2002-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Radiation therapy uses high-energy x-rays to damage tumor cells Peripheral stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy
PURPOSE This phase II trial is studying how well combination chemotherapy regimens with or without radiation therapy or peripheral stem cell transplant works in treating children with Hodgkins lymphoma
PURPOSE This phase II trial is studying how well combination chemotherapy regimens with or without radiation therapy or peripheral stem cell transplant works in treating children with Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine whether the current survival figures are maintained and long-term sequelae of treatment are minimized in children or adolescents with stage I-III Hodgkins lymphoma after receiving the following regimen which reduces exposure to chemotherapy and radiotherapy chlorambucil vinblastine prednisolone and procarbazine ChIVPP and doxorubicin bleomycin vincristine and dacarbazine ABVD with etoposide prednisolone ifosfamide and cisplatin EPIC radiotherapy high-dose melphalan andor autologous peripheral blood stem cell transplantation APBSCT
Determine whether the survival figures are improved in children or adolescents with stage IV Hodgkins lymphoma or inadequate response to initial therapy after receiving ChIVPP and ABVD with EPIC radiotherapy high-dose melphalan and APBSCT
OUTLINE This is a multicenter study Patients are assigned to 1 of 3 treatment groups based on disease status
Group 1 stage I disease All patients with mixed cellularity and younger patients with any subtype are assigned to subgroup A Older patients without mixed cellularity are assigned to subgroup A or B based on the decision of the physicians and patientsparents Subgroup A Patients receive 2 courses of the hybrid regimen One course of the hybrid regimen comprises regimen ChIVPP followed by regimen ABVD Regimen ChIVPP comprises vinblastine IV on days 1 and 8 and oral chlorambucil oral procarbazine and oral prednisolone PRDL daily on days 1-14 Regimen ABVD comprises doxorubicin IV over 6 hours bleomycin IV over 15-30 minutes vincristine IV and dacarbazine IV over 15 minutes on days 1 and 14 Patients with relapsed disease receive etoposide IV over 1 hour on days 1-4 oral PRDL and ifosfamide IV over 1 hour on days 1-5 and cisplatin IV over 24 hours on day 10 EPIC Treatment with EPIC continues every 3 weeks for a total of 6 courses Patients then undergo radiotherapy Patients with poor response after radiotherapy receive consolidation with high-dose melphalan L-PAM IV over 30-90 minutes followed at least 12 hours later by autologous peripheral blood stem cell transplantation APBSCT if there is no bone marrow involvement at the time of relapse Subgroup B Patients not in subgroup A may either receive chemotherapy as outlined or radiotherapy depending on clinician and patient discussion Patients with relapsed disease after radiotherapy receive 3 courses of the hybrid regimen If relapse occurs outside the initial radiotherapy field then further radiotherapy is administered
Group 2 stage II or III disease Patients receive 3 courses of the hybrid regimen Patients with relapsed disease receive 4 courses of EPIC Patients with complete remission CR or good partial remission GPR after the fourth course of EPIC receive 2 additional courses of EPIC followed by radiotherapy Patients without CR or GPR after the fourth course of EPIC undergo radiotherapy followed by L-PAM and APBSCT as in group 1 subgroup A
Group 3 stage IV or inadequate response to initial therapy Patients receive 2 courses the hybrid regimen Patients with CR or GPR after the second course of ABVD are assigned to subgroup C Patients without CR or GPR after the second course of ABVD are assigned to subgroup D Subgroup C Patients receive 2 additional courses of the hybrid regimen Patients with relapsed disease after the fourth course of ABVD receive 4 courses of EPIC followed by radiotherapy L-PAM and APBSCT as in group 1 subgroup A Subgroup D Patients receive 4 courses of EPIC followed by radiotherapy L-PAM and APBSCT as in group 1 subgroup A
Patients are followed every 2 months for 1 year every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 260 patients 75 with stage I disease 150 with stage II or III disease and 35 with stage IV disease will be accrued for this study within 5 years
Determine whether the current survival figures are maintained and long-term sequelae of treatment are minimized in children or adolescents with stage I-III Hodgkins lymphoma after receiving the following regimen which reduces exposure to chemotherapy and radiotherapy chlorambucil vinblastine prednisolone and procarbazine ChIVPP and doxorubicin bleomycin vincristine and dacarbazine ABVD with etoposide prednisolone ifosfamide and cisplatin EPIC radiotherapy high-dose melphalan andor autologous peripheral blood stem cell transplantation APBSCT
Determine whether the survival figures are improved in children or adolescents with stage IV Hodgkins lymphoma or inadequate response to initial therapy after receiving ChIVPP and ABVD with EPIC radiotherapy high-dose melphalan and APBSCT
OUTLINE This is a multicenter study Patients are assigned to 1 of 3 treatment groups based on disease status
Group 1 stage I disease All patients with mixed cellularity and younger patients with any subtype are assigned to subgroup A Older patients without mixed cellularity are assigned to subgroup A or B based on the decision of the physicians and patientsparents Subgroup A Patients receive 2 courses of the hybrid regimen One course of the hybrid regimen comprises regimen ChIVPP followed by regimen ABVD Regimen ChIVPP comprises vinblastine IV on days 1 and 8 and oral chlorambucil oral procarbazine and oral prednisolone PRDL daily on days 1-14 Regimen ABVD comprises doxorubicin IV over 6 hours bleomycin IV over 15-30 minutes vincristine IV and dacarbazine IV over 15 minutes on days 1 and 14 Patients with relapsed disease receive etoposide IV over 1 hour on days 1-4 oral PRDL and ifosfamide IV over 1 hour on days 1-5 and cisplatin IV over 24 hours on day 10 EPIC Treatment with EPIC continues every 3 weeks for a total of 6 courses Patients then undergo radiotherapy Patients with poor response after radiotherapy receive consolidation with high-dose melphalan L-PAM IV over 30-90 minutes followed at least 12 hours later by autologous peripheral blood stem cell transplantation APBSCT if there is no bone marrow involvement at the time of relapse Subgroup B Patients not in subgroup A may either receive chemotherapy as outlined or radiotherapy depending on clinician and patient discussion Patients with relapsed disease after radiotherapy receive 3 courses of the hybrid regimen If relapse occurs outside the initial radiotherapy field then further radiotherapy is administered
Group 2 stage II or III disease Patients receive 3 courses of the hybrid regimen Patients with relapsed disease receive 4 courses of EPIC Patients with complete remission CR or good partial remission GPR after the fourth course of EPIC receive 2 additional courses of EPIC followed by radiotherapy Patients without CR or GPR after the fourth course of EPIC undergo radiotherapy followed by L-PAM and APBSCT as in group 1 subgroup A
Group 3 stage IV or inadequate response to initial therapy Patients receive 2 courses the hybrid regimen Patients with CR or GPR after the second course of ABVD are assigned to subgroup C Patients without CR or GPR after the second course of ABVD are assigned to subgroup D Subgroup C Patients receive 2 additional courses of the hybrid regimen Patients with relapsed disease after the fourth course of ABVD receive 4 courses of EPIC followed by radiotherapy L-PAM and APBSCT as in group 1 subgroup A Subgroup D Patients receive 4 courses of EPIC followed by radiotherapy L-PAM and APBSCT as in group 1 subgroup A
Patients are followed every 2 months for 1 year every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL Approximately 260 patients 75 with stage I disease 150 with stage II or III disease and 35 with stage IV disease will be accrued for this study within 5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20108 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068901 | REGISTRY | None | None |