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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225173

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

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00225173     History of Changes
Other Study ID Numbers: G6HD, NIH/CA56060
Study First Received: September 21, 2005
Last Updated: August 26, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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
Etoposide
Doxorubicin
Cyclophosphamide
Etoposide phosphate
Liposomal doxorubicin
Vinorelbine
Vincristine
Prednisone
Vinblastine
Bleomycin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 30, 2014