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

NCT00225173 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2014-08-27

No results posted yet for this study

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.

Conditions

  • Hodgkin Disease

Interventions

DRUG

Doxorubicin

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

DRUG

Vinblastine

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

DRUG

Cyclophosphamide

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

DRUG

Etoposide

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

DRUG

Vincristine

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

DRUG

Bleomycin

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

DRUG

Gemcitabine

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

DRUG

Vinorelbine

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

DRUG

Prednisone

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

Sponsors & Collaborators

Principal Investigators

  • Sandra J. Horning, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2005-09-30
Completion
2006-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00225173 on ClinicalTrials.gov