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

• Status: Terminated
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bleomycin; Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Gemcitabine; Liposomal doxorubicin; Prednisone; Vinblastine; Vincristine; Vinorelbine

Criteria

Inclusion Criteria:

• Untreated, locally extensive or advanced stage classical Hodgkin's disease

• 3 or more adverse risk factors

• Age > 18 years and < 70 years.

• No prior invasive malignancies for > 5 years except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

• ECOG performance status 0 to 2

• WBC > 4000/µL

• Platelets > 100,000/µL

• Creatinine < 2.0mg/dL

• Bilirubin < 5.0mg/dL

Exclusion Criteria:

• HIV-positive

• Pregnant or currently breast feeding women

• Lymphocyte predominant Hodgkin's disease