Combination Chemotherapy +/- Radiation in High Risk Hodgkin's Disease
August 26, 2014 updated by: Stanford University
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
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.
Study Overview
Status
Terminated
Conditions
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 Type
Interventional
Enrollment (Anticipated)
45
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Treatment
|
Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
Other Names:
Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
Other Names:
Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
Other Names:
Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
Other Names:
Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
Other Names:
Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
Other Names:
Gemcitabine 1250 mg/m2 IV w 13,15,17,19
Other Names:
Vinorelbine 25 mg/m2 IV w 13,15,17,19
Other Names:
Prednisone 40 mg/m2 PO qod w 1-10, taper
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Freedom from progression
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Primary Completion (ACTUAL)
September 1, 2005
Study Completion (ACTUAL)
September 1, 2006
Study Registration Dates
First Submitted
September 21, 2005
First Submitted That Met QC Criteria
September 21, 2005
First Posted (ESTIMATE)
September 23, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
August 27, 2014
Last Update Submitted That Met QC Criteria
August 26, 2014
Last Verified
September 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Hodgkin Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Gemcitabine
- Cyclophosphamide
- Etoposide
- Etoposide phosphate
- Prednisone
- Doxorubicin
- Vinorelbine
- Vincristine
- Bleomycin
- Vinblastine
Other Study ID Numbers
- G6HD
- NIH/CA56060
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.