Combination Chemotherapy +/- Radiation in High Risk Hodgkin's Disease
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- To assess freedom from progression.
- To assess overall survival and failure-free survival.
- To assess: freedom from second relapse; incidence of second cancers; reproductive function;deaths from causes other than Hodgkin's disease
|Study Start Date:||October 2001|
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
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|Study Chair:||Sandra J. Horning, MD||Stanford University|