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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00225173
First received: September 21, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 21, 2005
September 21, 2005
October 2001
Not Provided
  • To assess freedom from progression.
  • To assess overall survival and failure-free survival.
Same as current
No Changes Posted
To assess: freedom from second relapse; incidence of second cancers; reproductive function;deaths from causes other than Hodgkin's disease
Same as current
Not Provided
Not Provided
 
Combination Chemotherapy +/- Radiation in High Risk Hodgkin's Disease
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

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.

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

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
45
Not Provided
Not Provided

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00225173
G6HD, NIH/CA56060
Not Provided
Not Provided
Stanford University
National Cancer Institute (NCI)
Study Chair: Sandra J. Horning, MD Stanford University
Stanford University
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP