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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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Hodgkin Disease

Thank you

Trial Information

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 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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess freedom from progression.

Principal Investigator

Sandra J. Horning, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Stanford University

Authority:

United States: Food and Drug Administration

Study ID:

G6HD

NCT ID:

NCT00225173

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Hodgkin Disease
  • nodular sclerosis
  • lymphocyte rich
  • lymphocyte depleted
  • mixed cellularity
  • Hodgkin Disease

Name

Location
Stanford University Medical Center Stanford, California  94305-5408