Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003262
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Hodgkins Disease and HIV Infection
Sponsor:
Centro di Riferimento Oncologico - Aviano
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Prospective Non Randomized Study With Chemotherapy in Patients With Hodgkins Disease and HIV Infection Stanford V Regimen For Low Risk Patients EBVP Regimen For High Risk Patients
Status:
UNKNOWN
Status Verified Date:
2002-10
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 tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of two combination chemotherapy regimens in treating patients with Hodgkins disease and HIV infection
PURPOSE Phase II trial to study the effectiveness of two combination chemotherapy regimens in treating patients with Hodgkins disease and HIV infection
Detailed Description:
OBJECTIVES
Investigate the effects on survival life expectancy and quality toxicity and immunological status in low risk patients with Hodgkins Disease and HIV infection treated with the Stanford V regimen and in high risk patients treated with epirubicin bleomycin vinblastine and prednisone
OUTLINE Patients are stratified into 2 groups designated as low and high risk on the basis of ECOG performance status 0-2 vs 3-4 presence or absence of AIDS before the diagnosis of Hodgkins Disease and immune status CD4 cell count greater vs no greater than 100mm3
Low risk patients those with no risk factors receive the EBVP regimen as follows
Epirubicin intravenously on day 1
Bleomycin intramuscularly or intravenously on day 1
Vinblastine intravenously on day 1
Prednisone orally on days 1-5
Patients also receive daily injections of filgrastim granulocyte colony-stimulating factor G-CSF on days 6-15 This schedule is repeated every 3 weeks for 6 courses
High risk patients those with one or more risk factors receive the Stanford V regimen as follows
Doxorubicin and vinblastine intravenously on days 1 and 15
Mechlorethamine intravenously on day 1
Vincristine and bleomycin intravenously on days 8 and 22
Etoposide intravenously on days 15 and 16
Prednisone orally daily
Patients also receive daily injections of G-CSF on days 3-7 9-13 17-21 and 23-26 This schedule is repeated every 28 days for 3 courses
Patients are followed every 2 months the first year and then every 3 months thereafter
PROJECTED ACCRUAL 20-30 patients will initially be accrued in this study
Investigate the effects on survival life expectancy and quality toxicity and immunological status in low risk patients with Hodgkins Disease and HIV infection treated with the Stanford V regimen and in high risk patients treated with epirubicin bleomycin vinblastine and prednisone
OUTLINE Patients are stratified into 2 groups designated as low and high risk on the basis of ECOG performance status 0-2 vs 3-4 presence or absence of AIDS before the diagnosis of Hodgkins Disease and immune status CD4 cell count greater vs no greater than 100mm3
Low risk patients those with no risk factors receive the EBVP regimen as follows
Epirubicin intravenously on day 1
Bleomycin intramuscularly or intravenously on day 1
Vinblastine intravenously on day 1
Prednisone orally on days 1-5
Patients also receive daily injections of filgrastim granulocyte colony-stimulating factor G-CSF on days 6-15 This schedule is repeated every 3 weeks for 6 courses
High risk patients those with one or more risk factors receive the Stanford V regimen as follows
Doxorubicin and vinblastine intravenously on days 1 and 15
Mechlorethamine intravenously on day 1
Vincristine and bleomycin intravenously on days 8 and 22
Etoposide intravenously on days 15 and 16
Prednisone orally daily
Patients also receive daily injections of G-CSF on days 3-7 9-13 17-21 and 23-26 This schedule is repeated every 28 days for 3 courses
Patients are followed every 2 months the first year and then every 3 months thereafter
PROJECTED ACCRUAL 20-30 patients will initially be accrued in 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 |
|---|---|---|---|
| ITA-GICAT-POS5 | None | None | None |
| EU-97022 | None | None | None |