Spots Global Cancer Trial Database for Combination Chemotherapy +/- Radiation in High Risk Hodgkin's Disease

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Trial Identification

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

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

Study ID: NCT00225173

Conditions

Hodgkin Disease

Interventions

Study Description

Brief 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