Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma
OBJECTIVES:
Primary
- Determine the complete response rate in patients with newly diagnosed stage IA, IB,
IIA, or IIB non-bulky Hodgkin's lymphoma treated with doxorubicin, vinblastine, and
gemcitabine.
Secondary
- Determine the event-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine whether fludeoxyglucose F 18 positron-emission tomography scanning is useful
in predicting clinical relapse and determining the presence of residual disease in
these patients after treatment with this regimen.
OUTLINE: This is a multicenter study.
Patients receive doxorubicin IV over 3-5 minutes, vinblastine IV over 3-5 minutes, and
gemcitabine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6
courses in the absence of disease progression or unacceptable toxicity.
Patients undergo fludeoxyglucose F 18 positron-emission tomography (PET) scanning and CT
scan before treatment and after courses 2 and 6 of therapy to assess response. Patients with
a positive PET scan after completion of study therapy may undergo biopsy. A PET scan is
performed 3 months later if biopsy is negative or biopsy is unable to be performed.
Patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months
for 2 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 98 patients will be accrued for this study within 3 years.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response
24 weeks
No
David J. Straus, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
CDR0000370870
NCT00086801
May 2004
May 2011
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
CCOP - Greenville | Greenville, South Carolina 29615 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
University of Minnesota Medical Center - Fairview | Minneapolis, Minnesota 55455 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Omaha, Nebraska 68198-7680 |
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | Saint Joseph, Michigan 49085 |
New York Weill Cornell Cancer Center at Cornell University | New York, New York 10021 |
Lenoir Memorial Cancer Center | Kinston, North Carolina 28503-1678 |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Beebe Medical Center | Lewes, Delaware 19958 |
Howard Community Hospital at Howard Regional Health System | Kokomo, Indiana 46904 |
Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
Union Hospital Cancer Center at Union Hospital | Elkton MD, Maryland 21921 |
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center | Grand Island, Nebraska 68803 |
Great Plains Regional Medical Center | North Platte, Nebraska 69101-6598 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
Wilson Medical Center | Wilson, North Carolina 27893-3428 |
Bon Secours St. Francis Health System | Greenville, South Carolina 29601 |
Mountainview Medical | Berlin, Vermont 05602 |
Missouri Cancer Associates | Columbia, Missouri 65201 |
Dana-Farber/Brigham and Women's Cancer Center | Boston, Massachusetts 02115 |
Iowa Blood and Cancer Care | Cedar Rapids, Iowa 52402 |
Community General Hospital | Syracuse, New York 13215 |