Combination Chemotherapy +/- Radiation in High Risk Hodgkin's Disease
Phase 2
Terminated
- Conditions
- Hodgkin Disease
- Interventions
- Registration Number
- NCT00225173
- Lead Sponsor
- Stanford University
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Doxorubicin * 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 Treatment Vinblastine * 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 Treatment Cyclophosphamide * 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 Treatment Gemcitabine * 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 Treatment Vincristine * 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 Treatment Etoposide * 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 Treatment Bleomycin * 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 Treatment Vinorelbine * 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 Treatment Prednisone * 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
- Primary Outcome Measures
Name Time Method Freedom from progression
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Stanford University Medical Center
🇺🇸Stanford, California, United States