Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005090
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2000-04-06
Brief Title:
S9901 Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Stage III or Stage IV Hodgkins Disease
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
A Randomized Phase III Trial Comparing Early High Dose Chemotherapy and an Autologous Stem Cell Transplant to Conventional Dose ABVD Chemotherapy for Patients With Advanced Stage Poor Prognosis Hodgkins Disease as Defined by the International Prognostic Factors Project on Advanced Hodgkins Disease
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
poor accrual
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 tumor cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells It is not yet known if combination chemotherapy is more effective with or without peripheral stem cell transplantation in treating Hodgkins Disease
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without peripheral stem cell transplantation in treating men who have stage III or stage IV Hodgkins disease
PURPOSE Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without peripheral stem cell transplantation in treating men who have stage III or stage IV Hodgkins disease
Detailed Description:
OBJECTIVES
Compare progression-free and overall survival of patients with stage III or IV Hodgkins disease treated with doxorubicin bleomycin vinblastine and dacarbazine with or without autologous peripheral blood stem cell transplantation and high-dose chemotherapy
Compare the toxic effects of these treatment regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to number of poor prognostic factors 3 vs 4 vs 5 and stage of disease III vs IV
Patients receive induction chemotherapy consisting of doxorubicin IV over 5 minutes bleomycin IV over 10 minutes vinblastine IV over 5 minutes and dacarbazine IV over 15-30 minutes on days 1 and 15 Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity Patients who show at least partial response after the fifth course of induction chemotherapy and whose blood counts have recovered are randomized to 1 of 2 treatment arms
Arm I Patients receive 3 additional courses of induction chemotherapy for a total of 8 courses
Arm II Patients receive 1 additional course of induction chemotherapy followed by stem cell collection Patients then receive high-dose chemotherapy with carmustine IV over 2 hours on days -6 to -4 etoposide IV over 4 hours on day -4 and cyclophosphamide IV on day -2 Patients undergo autologous peripheral blood stem cell transplantation on day 0
Patients are followed at 60 days every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 460 patients will be accrued for this study within 4 years
Compare progression-free and overall survival of patients with stage III or IV Hodgkins disease treated with doxorubicin bleomycin vinblastine and dacarbazine with or without autologous peripheral blood stem cell transplantation and high-dose chemotherapy
Compare the toxic effects of these treatment regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to number of poor prognostic factors 3 vs 4 vs 5 and stage of disease III vs IV
Patients receive induction chemotherapy consisting of doxorubicin IV over 5 minutes bleomycin IV over 10 minutes vinblastine IV over 5 minutes and dacarbazine IV over 15-30 minutes on days 1 and 15 Treatment repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity Patients who show at least partial response after the fifth course of induction chemotherapy and whose blood counts have recovered are randomized to 1 of 2 treatment arms
Arm I Patients receive 3 additional courses of induction chemotherapy for a total of 8 courses
Arm II Patients receive 1 additional course of induction chemotherapy followed by stem cell collection Patients then receive high-dose chemotherapy with carmustine IV over 2 hours on days -6 to -4 etoposide IV over 4 hours on day -4 and cyclophosphamide IV on day -2 Patients undergo autologous peripheral blood stem cell transplantation on day 0
Patients are followed at 60 days every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 460 patients will be accrued for this study within 4 years
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 |
|---|---|---|---|
| U10CA032102 | NIH | ECOG | httpsreporternihgovquickSearchU10CA032102 |
| S9901 | OTHER | None | None |
| CLB-59802 | OTHER | None | None |
| E-S9901 | OTHER | None | None |