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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00225173

Enrollment

Registered

2005-09-23

Start date

2001-10-31

Completion date

2006-09-30

Last updated

2014-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Disease

Keywords

nodular sclerosis, lymphocyte rich, lymphocyte depleted, mixed cellularity

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.

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

Interventions

DRUGDoxorubicin

Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11

DRUGVinblastine

Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11

DRUGCyclophosphamide

Cyclophosphamide 750 mg/m2 IV w 1, 5, 9

DRUGEtoposide

Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11

DRUGVincristine

Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)

DRUGBleomycin

Bleomycin 5 u/m2 IV w 2,4,6,8,10,12

DRUGGemcitabine

Gemcitabine 1250 mg/m2 IV w 13,15,17,19

DRUGVinorelbine

Vinorelbine 25 mg/m2 IV w 13,15,17,19

DRUGPrednisone

Prednisone 40 mg/m2 PO qod w 1-10, taper

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Exclusion criteria

* HIV-positive * Pregnant or currently breast feeding women * Lymphocyte predominant Hodgkin's disease

Design outcomes

Primary

Measure	Time frame
Freedom from progression	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026