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

Hodgkin Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00225173
• Other study ID #: G6HD
• Secondary ID: NIH/CA56060
• Status: Terminated
• Phase: Phase 2
• First received: September 21, 2005
• Last updated: August 26, 2014
• Start date: October 2001
• Est. completion date: September 2006

Study information

• Verified date: September 2005
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: September 2006
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hodgkin Disease

Intervention

Drug:
• Doxorubicin
Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
• Vinblastine
Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
• Cyclophosphamide
Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
• Etoposide
Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
• Vincristine
Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
• Bleomycin
Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
• Gemcitabine
Gemcitabine 1250 mg/m2 IV w 13,15,17,19
• Vinorelbine
Vinorelbine 25 mg/m2 IV w 13,15,17,19
• Prednisone
Prednisone 40 mg/m2 PO qod w 1-10, taper

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from progression