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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00225173
First Posted: September 23, 2005
Last Update Posted: August 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Stanford University
  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 Intervention Phase
Hodgkin Disease Drug: Doxorubicin Drug: Vinblastine Drug: Cyclophosphamide Drug: Etoposide Drug: Vincristine Drug: Bleomycin Drug: Gemcitabine Drug: Vinorelbine Drug: Prednisone Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Freedom from progression

Estimated Enrollment: 45
Study Start Date: October 2001
Study Completion Date: September 2006
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225173


Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
Study Chair: Sandra J. Horning, MD Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00225173     History of Changes
Other Study ID Numbers: G6HD
NIH/CA56060
First Submitted: September 21, 2005
First Posted: September 23, 2005
Last Update Posted: August 27, 2014
Last Verified: September 2005

Keywords provided by Stanford University:
nodular sclerosis
lymphocyte rich
lymphocyte depleted
mixed cellularity

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Doxorubicin
Etoposide
Cyclophosphamide
Liposomal doxorubicin
Etoposide phosphate
Vinorelbine
Prednisone
Vincristine
Vinblastine
Bleomycin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents