Combination Chemotherapy +/- Radiation in High Risk Hodgkin's Disease

Hodgkin Disease Clinical Trial

Official title: A Phase II Trial of Stanford VI ± Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease With 3+ Risk Factors: the G6 Study

Status Terminated

Clinical Trial Summary

Patients with 3 or more adverse prognostic factors have a higher relapse rate. Significant anti-tumor activity in Hodgkin's lymphoma has been reported with two new drugs:gemcitabine 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.

Clinical Trial Description

Patients will receive chemotherapy weekly for 19 weeks, alone or followed by irradiation as indicated per protocol guidelines.

• Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11

• Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11

• Cyclophosphamide 750 mg/m2 IV w 1, 5, 9

• Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11

• Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)

• Bleomycin 5 u/m2 IV w 2,4,6,8,10,12

• Gemcitabine 1250 mg/m2 IV w 13,15,17,19

• Vinorelbine 25 mg/m2 IV w 13,15,17,19

• Prednisone 40 mg/m2 PO qod w 1-10, taper ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease

• NCT number: NCT00225173
• Study type: Interventional
• Source: Stanford University
• Status: Terminated
• Phase: Phase 2
• Start date: October 2001
• Completion date: September 2006