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

Sponsor

Stanford University (Other)

Overall Status

Terminated

CT.gov ID

NCT00225173

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hodgkin Disease	Drug: Doxorubicin Drug: Vinblastine Drug: Cyclophosphamide Drug: Etoposide Drug: Vincristine Drug: Bleomycin Drug: Gemcitabine Drug: Vinorelbine Drug: Prednisone	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

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

Study Start Date :

Oct 1, 2001

Actual Primary Completion Date :

Sep 1, 2005

Actual Study Completion Date :

Sep 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Freedom from progression []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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