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

This study has been terminated.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
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
  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,vinblastine,cyclophosphamide,etoposide,vincristine,bleomycin,gemcitabine,vinorelbine,prednisone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • To assess freedom from progression.
  • To assess overall survival and failure-free survival.

Secondary Outcome Measures:
  • To assess: freedom from second relapse; incidence of second cancers; reproductive function;deaths from causes other than Hodgkin's disease

Estimated Enrollment: 45
Study Start Date: October 2001
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
  • 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
  Contacts and Locations
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
National Cancer Institute (NCI)
Investigators
Study Chair: Sandra J. Horning, MD Stanford University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00225173     History of Changes
Other Study ID Numbers: G6HD, NIH/CA56060
Study First Received: September 21, 2005
Last Updated: September 21, 2005
Health Authority: United States: Food and Drug Administration

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
Bleomycin
Doxorubicin
Gemcitabine
Vinorelbine
Cyclophosphamide
Etoposide
Prednisone
 Vinblastine
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 22, 2013