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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00225173
First received: September 21, 2005
Last updated: August 26, 2014
Last verified: September 2005

September 21, 2005
August 26, 2014
October 2001
September 2005   (final data collection date for primary outcome measure)
Freedom from progression
  • To assess freedom from progression.
  • To assess overall survival and failure-free survival.
Complete list of historical versions of study NCT00225173 on ClinicalTrials.gov Archive Site
Not Provided
To assess: freedom from second relapse; incidence of second cancers; reproductive function;deaths from causes other than Hodgkin's disease
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hodgkin Disease
  • Drug: Doxorubicin
    Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
    Other Names:
    • Adriamycin
    • hydroxydaunorubicin
    • hydroxydaunomycin
  • Drug: Vinblastine
    Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
    Other Names:
    • Alkaban-AQ
    • Velban
    • Vinblastine sulfate
    • Vincaleukoblastine
    • VLB
  • Drug: Cyclophosphamide
    Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
    Other Names:
    • Cytoxan
    • Endoxan
    • Neosar
    • Procytox
    • Revimmune
    • cytophosphane
  • Drug: Etoposide
    Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
    Other Names:
    • Etopophos
    • Toposar
    • VePesid
    • etoposide phosphate
    • VP-16
  • Drug: Vincristine
    Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
    Other Names:
    • Oncovin
    • leurocristine
    • VCR
  • Drug: Bleomycin
    Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
    Other Names:
    • Blenoxane
    • bleomycin sulfate
  • Drug: Gemcitabine
    Gemcitabine 1250 mg/m2 IV w 13,15,17,19
    Other Names:
    • Gemzar
    • Gemcitabine HCl
  • Drug: Vinorelbine
    Vinorelbine 25 mg/m2 IV w 13,15,17,19
    Other Names:
    • Navelbine
    • Vinorelbine tartrate
  • Drug: Prednisone
    Prednisone 40 mg/m2 PO qod w 1-10, taper
    Other Names:
    • Deltasone
    • Liquid Pred
Experimental: Treatment
  • 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
Interventions:
  • Drug: Doxorubicin
  • Drug: Vinblastine
  • Drug: Cyclophosphamide
  • Drug: Etoposide
  • Drug: Vincristine
  • Drug: Bleomycin
  • Drug: Gemcitabine
  • Drug: Vinorelbine
  • Drug: Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
45
September 2006
September 2005   (final data collection date for primary outcome measure)

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
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
Stanford University
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