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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Hodgkin Disease
Intervention	Drug: doxorubicin,vinblastine,cyclophosphamide,etoposide,vincristine,bleomycin,gemcitabine,vinorelbine,prednisone
Phase	Phase 2
Sponsor	Stanford University
Responsible Party	Stanford University
ClinicalTrials.gov Identifier	NCT00225173
First Received	September 21, 2005
Last Updated	September 21, 2005
Last verified	September 2005

Tracking Information[ + expand ][ + ]

First Received Date	September 21, 2005
Last Updated Date	September 21, 2005
Start Date	October 2001
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	To assess freedom from progression. To assess overall survival and failure-free survival.
Current Secondary Outcome Measures	To assess: freedom from second relapse; incidence of second cancers; reproductive function;deaths from causes other than Hodgkin's disease

Descriptive Information[ + expand ][ + ]

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
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
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Hodgkin Disease
Intervention	Drug: doxorubicin,vinblastine,cyclophosphamide,etoposide,vincristine,bleomycin,gemcitabine,vinorelbine,prednisone
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	45
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	Not Provided
Eligibility Criteria	Inclusion Criteria: - Untreated, locally extensive or advanced stage classical Hodgkin’s disease - Three 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 0-2 - WBC>4000/µl,platelet count>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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00225173
Other Study ID Numbers	G6HD
Has Data Monitoring Committee	Not Provided
Information Provided By	Stanford University
Study Sponsor	Stanford University
Collaborators	National Cancer Institute (NCI)
Investigators	Study Chair: Sandra J. Horning, MD Stanford University
Verification Date	September 2005

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