Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079105
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2004-03-08
Brief Title:
A Phase II Study VEPEMB In Patients With Hodgkins Lymphoma Aged 60 Years
Sponsor:
Newcastle-upon-Tyne Hospitals NHS Trust
Organization:
Newcastle-upon-Tyne Hospitals NHS Trust
Study Overview
Official Title:
A Phase II Study VEPEMB In Patients With Hodgkins Lymphoma Aged 60 Years Vinblastine Cyclophosphamide Procarbazine Prednisolone Etoposide Mitoxantrone and Bleomycin in Treating Older Patients With Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-03
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 such as vinblastine cyclophosphamide procarbazine prednisolone etoposide mitoxantrone and bleomycin work in different ways to stop cancer cells from dividing so they stop growing or die Combining more than one chemotherapy drug may kill more cancer cells
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkins lymphoma
PURPOSE This phase II trial is studying how well combination chemotherapy works in treating older patients with previously untreated Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy and toxicity of vinblastine cyclophosphamide procarbazine prednisolone etoposide mitoxantrone and bleomycin in older patients with Hodgkins lymphoma
Determine whether the application of the Hasenclever prognostic index is valid in these patients at diagnosis
OUTLINE This is an open-label multicenter study
Chemotherapy Patients receive vinblastine IV and cyclophosphamide IV on day 1 oral procarbazine and oral prednisolone on days 1-5 oral etoposide on days 15-19 and mitoxantrone IV and bleomycin IV on day 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity for a total of 3 courses in patients with early stage IA or IIA disease or 6 courses in patients with advanced stage IB or IIB-IV disease
Radiotherapy Patients with early stage disease receive involved-field radiotherapy Patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease Radiotherapy begins 4 weeks after the completion of chemotherapy
Patients are followed monthly for 3 months every 3 months for 6 months and then annually thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study within 36 months
Primary
Determine the efficacy and toxicity of vinblastine cyclophosphamide procarbazine prednisolone etoposide mitoxantrone and bleomycin in older patients with Hodgkins lymphoma
Determine whether the application of the Hasenclever prognostic index is valid in these patients at diagnosis
OUTLINE This is an open-label multicenter study
Chemotherapy Patients receive vinblastine IV and cyclophosphamide IV on day 1 oral procarbazine and oral prednisolone on days 1-5 oral etoposide on days 15-19 and mitoxantrone IV and bleomycin IV on day 15 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity for a total of 3 courses in patients with early stage IA or IIA disease or 6 courses in patients with advanced stage IB or IIB-IV disease
Radiotherapy Patients with early stage disease receive involved-field radiotherapy Patients with advanced stage disease receive radiotherapy limited to sites of initial bulky disease or residual disease Radiotherapy begins 4 weeks after the completion of chemotherapy
Patients are followed monthly for 3 months every 3 months for 6 months and then annually thereafter
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL A total of 150 patients will be accrued for this study within 36 months
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 |
|---|---|---|---|
| EU-20346 | OTHER | Sponsor | None |
| UON-SHIELD | OTHER | None | None |