Viewing Study NCT00225173



Ignite Creation Date: 2024-05-05 @ 12:03 PM
Last Modification Date: 2024-10-26 @ 9:19 AM
Study NCT ID: NCT00225173
Status: TERMINATED
Last Update Posted: 2014-08-27
First Post: 2005-09-21

Brief Title: Combination Chemotherapy - Radiation in High Risk Hodgkins Disease
Sponsor: Stanford University
Organization: Stanford University

Study Overview

Official Title: A Phase II Trial of Stanford VI Radiation Therapy in Locally Extensive and Advanced Stage Hodgkins Disease With 3 Risk Factors the G6 Study
Status: TERMINATED
Status Verified Date: 2005-09
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: Patients with 3 or more adverse prognostic factors have a higher relapse rate Significant anti-tumor activity in Hodgkins lymphoma has been reported with two new drugsgemcitabine and vinorelbine The introduction of these new agents with their different mechanisms of action into the Stanford V regimen may increase effectiveness while maintaining a favorable toxicity profile with respect to fertility and a low risk of secondary leukemia On this basis we propose a new regimen Stanford VI for patients with bulky and advanced HD with 3 or more risk factors
Detailed Description: Patients will receive chemotherapy weekly for 19 weeks alone or followed by irradiation as indicated per protocol guidelines

Doxorubicin 25 mgm2 IV w 1357911
Vinblastine 6 mgm2 IV w 1357911
Cyclophosphamide 750 mgm2 IV w 1 5 9
Etoposide2 60 mgmg2 x 2 IV w 3 711
Vincristine1 14 mgm2 IV w 24681012 cap 2mg
Bleomycin 5 um2 IV w 24681012
Gemcitabine 1250 mgm2 IV w 13151719
Vinorelbine 25 mgm2 IV w 13151719
Prednisone 40 mgm2 PO qod w 1-10 taper

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
NIHCA56060 None None None