Status:
TERMINATED
Combination Chemotherapy +/- Radiation in High Risk Hodgkin's Disease
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Hodgkin Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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. T...
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,...
Eligibility Criteria
Inclusion
- 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
- HIV-positive
- Pregnant or currently breast feeding women
- Lymphocyte predominant Hodgkin's disease
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2006
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00225173
Start Date
October 1 2001
End Date
September 1 2006
Last Update
August 27 2014
Active Locations (1)
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1
Stanford University Medical Center
Stanford, California, United States, 94305