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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Hodgkin Disease

Intervention / Treatment
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* Drug: Doxorubicin
* Drug: Vinblastine
* Drug: Cyclophosphamide
* Drug: Etoposide
* Drug: Vincristine
* Drug: Bleomycin
* Drug: Gemcitabine
* Drug: Vinorelbine
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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 | Drug: Doxorubicin<br>* Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11<br>* Other names: hydroxydaunomycin;Drug: Vinblastine<br>* Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11<br>* Other names: VLB;Drug: Cyclophosphamide<br>* Cyclophosphamide 750 mg/m2 IV w 1, 5, 9<br>* Other names: cytophosphane;Drug: Etoposide<br>* Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11<br>* Other names: VP-16;Drug: Vincristine<br>* Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)<br>* Other names: VCR;Drug: Bleomycin<br>* Bleomycin 5 u/m2 IV w 2,4,6,8,10,12<br>* Other names: bleomycin sulfate;Drug: Gemcitabine<br>* Gemcitabine 1250 mg/m2 IV w 13,15,17,19<br>* Other names: Gemcitabine HCl;Drug: Vinorelbine<br>* Vinorelbine 25 mg/m2 IV w 13,15,17,19<br>* Other names: Vinorelbine tartrate;Drug: Prednisone<br>* Prednisone 40 mg/m2 PO qod w 1-10, taper<br>* Other names: Liquid Pred;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from progression |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nodular sclerosis, lymphocyte rich, lymphocyte depleted, mixed cellularity