Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041327
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2002-07-08
Brief Title:
Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell LeukemiaLymphoma
Sponsor:
AIDS Malignancy Consortium
Organization:
AIDS Malignancy Consortium
Study Overview
Official Title:
Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With CombivirInterferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-02
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 Antiviral therapy may kill viruses such as HTLV-1 that can cause cancer Interferon alfa may interfere with the growth of cancer cells Combining chemotherapy with antiviral drugs and interferon alfa may be effective in treating adult T-cell leukemialymphoma
PURPOSE Phase II trial to determine the effectiveness of combination chemotherapy followed by antiviral therapy and interferon alfa in treating patients who have adult T-cell leukemialymphoma caused by HTLV-1
PURPOSE Phase II trial to determine the effectiveness of combination chemotherapy followed by antiviral therapy and interferon alfa in treating patients who have adult T-cell leukemialymphoma caused by HTLV-1
Detailed Description:
OBJECTIVES
Determine the efficacy of etoposide prednisone vincristine cyclophosphamide and doxorubicin EPOCH followed by lamivudine zidovudine and interferon alfa in terms of response rate in patients with HTLV-1-associated adult T-cell leukemialymphoma
Determine the duration of response in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the effect of this regimen on markers of virus replication and expression and immune function in these patients
OUTLINE This is a multicenter study
Patients receive EPOCH chemotherapy comprising etoposide vincristine and doxorubicin IV continuously on days 1-5 cyclophosphamide IV over 30 minutes on day 5 and oral prednisone on days 1-5 Patients also receive filgrastim G-CSF subcutaneously SC daily beginning on day 7 and continuing until blood counts recover Treatment repeats every 21-28 days for at least 2 courses beyond best response or for up to 6 courses in the absence of unacceptable toxicity disease progression or stable disease
Beginning 1 month after completion of EPOCH patients receive oral lamivudine and zidovudine twice daily and interferon alfa SC daily continuously for 1 year
Patients are followed monthly for 1 year every 2 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 10-32 patients will be accrued for this study within 1-2 years
Determine the efficacy of etoposide prednisone vincristine cyclophosphamide and doxorubicin EPOCH followed by lamivudine zidovudine and interferon alfa in terms of response rate in patients with HTLV-1-associated adult T-cell leukemialymphoma
Determine the duration of response in patients treated with this regimen
Determine the toxicity of this regimen in these patients
Determine the effect of this regimen on markers of virus replication and expression and immune function in these patients
OUTLINE This is a multicenter study
Patients receive EPOCH chemotherapy comprising etoposide vincristine and doxorubicin IV continuously on days 1-5 cyclophosphamide IV over 30 minutes on day 5 and oral prednisone on days 1-5 Patients also receive filgrastim G-CSF subcutaneously SC daily beginning on day 7 and continuing until blood counts recover Treatment repeats every 21-28 days for at least 2 courses beyond best response or for up to 6 courses in the absence of unacceptable toxicity disease progression or stable disease
Beginning 1 month after completion of EPOCH patients receive oral lamivudine and zidovudine twice daily and interferon alfa SC daily continuously for 1 year
Patients are followed monthly for 1 year every 2 months for 1 year and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 10-32 patients will be accrued for this study within 1-2 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 |
|---|---|---|---|
| CDR0000069469 | OTHER | NCI | httpsreporternihgovquickSearchU01CA070019 |
| U01CA070019 | NIH | None | None |