NCT00225173

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Hodgkin Disease

Interventions

Type	Name	Description
DRUG	Doxorubicin	Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
DRUG	Vinblastine	Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
DRUG	Cyclophosphamide	Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
DRUG	Etoposide	Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
DRUG	Vincristine	Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
DRUG	Bleomycin	Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
DRUG	Gemcitabine	Gemcitabine 1250 mg/m2 IV w 13,15,17,19
DRUG	Vinorelbine	Vinorelbine 25 mg/m2 IV w 13,15,17,19
DRUG	Prednisone	Prednisone 40 mg/m2 PO qod w 1-10, taper

Timeline

• Start date: 2001-10-01
• Primary completion: 2005-09-01
• Completion: 2006-09-01
• First posted: 2005-09-23
• Last updated: 2014-08-27

Locations

1 site across 1 country: United States