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

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hodgkin Disease

Intervention: Doxorubicin (Drug); Vinblastine (Drug); Cyclophosphamide (Drug); Etoposide (Drug); Vincristine (Drug); Bleomycin (Drug); Gemcitabine (Drug); Vinorelbine (Drug); Prednisone (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Sandra J. Horning, MD, Study Chair, Affiliation: Stanford University

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.

Clinical Details

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

Primary outcome: Freedom from progression

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

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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/┬ÁL

- Platelets > 100,000/┬ÁL

- Creatinine < 2. 0mg/dL

- Bilirubin < 5. 0mg/dL

Exclusion Criteria:

- HIV-positive

- Pregnant or currently breast feeding women

- Lymphocyte predominant Hodgkin's disease

Locations and Contacts

Stanford University Medical Center, Stanford, California 94305, United States
Additional Information

Starting date: October 2001
Last updated: August 26, 2014

Page last updated: August 23, 2015

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