A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease
OBJECTIVES:
- Determine the response rate of pediatric patients with recurrent or refractory
Hodgkin's lymphoma treated with gemcitabine and vinorelbine.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive vinorelbine IV over 6-10 minutes and gemcitabine IV over 100 minutes on
days 1 and 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day
9 and continuing for at least 7 days and until blood counts recover. Treatment repeats every
21 days for at least 2 courses in the absence of disease progression or unacceptable
toxicity. Patients with responding disease after 2 courses may proceed directly to stem cell
transplantation off study OR receive 2 additional courses. Patients with stable disease
after 2 courses receive at least 2 additional courses. Patients with continued stable or
responding disease (with no disease progression) after 4 courses may continue to receive
study treatment for up to 1 year or discontinue study for alternative therapy at the
discretion of the treating physician.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study within 1.5
years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity
Toxic death, Hepatic, cardiac or renal toxicity, Hematologic toxicity, pulmonary toxicity or other grade 3 or 4 toxicities from interventions.
Up to 4 years.
Yes
Peter Cole, MD
Study Chair
Cancer Institute of New Jersey
United States: Federal Government
AHOD0321
NCT00070304
July 2004
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Hurley Medical Center | Flint, Michigan 48503 |
Medical City Dallas Hospital | Dallas, Texas 75230 |
University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Farmington, Connecticut 06360-2875 |
Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
New York Medical College | Valhalla, New York 10595 |
University of Miami Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |
UMASS Memorial Cancer Center - University Campus | Worcester, Massachusetts 01605-2982 |
Siteman Cancer Center at Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
CCOP - Scott and White Hospital | Temple, Texas 76508 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
Children's Mercy Hospital | Kansas City, Missouri 64108 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Nemours Children's Clinic | Jacksonville, Florida 32207 |
Miami Children's Hospital | Miami, Florida 33155-4069 |
All Children's Hospital | St. Petersburg, Florida 33701 |
Children's Memorial Hospital - Chicago | Chicago, Illinois 60614 |
Maine Children's Cancer Program | Scarborough, Maine 04074-9308 |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of New Mexico Cancer Research and Treatment Center | Albuquerque, New Mexico 87131 |
St. Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134-1095 |
St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
Driscoll Children's Hospital | Corpus Christi, Texas 78466 |
Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
Southern California Permanente Medical Group | Downey, California 90242 |
Children's Hospital Central California | Madera, California 93638-8762 |
Southern Illinois University School of Medicine | Springfield, Illinois 62794-9658 |
Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
Brooklyn Hospital Center | Brooklyn, New York 11201 |
Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
Children's Medical Center - Dayton | Dayton, Ohio 45404 |
East Tennessee Children's Hospital | Knoxville, Tennessee 37901 |
Covenant Children's Hospital | Lubbock, Texas 79410 |
Children's Hospital of the King's Daughters | Norfolk, Virginia 23507 |
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Markey Cancer Center at University of Kentucky Chandler Medical Center | Lexington, Kentucky 40536-0084 |
Herbert Irving Comprehensive Cancer Center at Columbia University | New York, New York 10032 |
Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
Overlook Hospital | Summit, New Jersey 07902-0220 |
Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
Loma Linda University Cancer Institute at Loma Linda University Medical Center | Loma Linda, California 92354 |
Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
Children's Hospital and Health Center - San Diego | San Diego, California 92123-4282 |
Lee Cancer Care of Lee Memorial Health System | Fort Myers, Florida 33901 |
University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
Nemours Children's Clinic - Orlando | Orlando, Florida 32806 |
Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
Sacred Heart Cancer Center at Sacred Heart Hospital | Pensacola, Florida 32504 |
St. Joseph's Cancer Institute at St. Joseph's Hospital | Tampa, Florida 33607 |
Kaplan Cancer Center at St. Mary's Medical Center | West Palm Beach, Florida 33407 |
Winship Cancer Institute of Emory University | Atlanta, Georgia 30322 |
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
Blank Children's Hospital | Des Moines, Iowa 50309 |
CancerCare of Maine at Eastern Maine Medial Center | Bangor, Maine 04401 |
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Baltimore, Maryland 21215 |
Floating Hospital for Children at Tufts - New England Medical Center | Boston, Massachusetts 02111 |
Breslin Cancer Center at Ingham Regional Medical Center | Lansing, Michigan 48910 |
Children's Hospitals and Clinics of Minneapolis | Minneapolis, Minnesota 55404 |
Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio 45229-3039 |
Rainbow Babies and Children's Hospital | Cleveland, Ohio 44106-5000 |
Legacy Emanuel Hospital and Health Center & Children's Hospital | Portland, Oregon 97227 |
Rhode Island Hospital Comprehensive Cancer Center | Providence, Rhode Island 02903 |
Greenville Hospital System Cancer Center | Greenville, South Carolina 29605 |
Texas Tech University Health Sciences Center School of Medicine - Amarillo | Amarillo, Texas 79106 |
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
Methodist Children's Hospital of South Texas | San Antonio, Texas 78229-3993 |
Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
Providence Cancer Center at Sacred Heart Medical Center | Spokane, Washington 99220-2555 |
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division | Charleston, West Virginia 25302 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
Alfred I. duPont Hospital for Children | Wilmington, Delaware 19803 |
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington, District of Columbia 20007 |
C.S. Mott Children's Hospital at University of Michigan Medical Center | Ann Arbor, Michigan 48109-0286 |
St. Barnabas Medical Center Cancer Center | Livingston, New Jersey 07039 |
Albany Medical Center Hospital | Albany, New York 12208-3419 |
Tod Children's Hospital | Youngstown, Ohio 44501 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Madigan Army Medical Center - Tacoma | Tacoma, Washington 98431 |
Mary Bridge Children's Hospital and Health Center - Tacoma | Tacoma, Washington 98405 |
Spectrum Health Hospital - Butterworth Campus | Grand Rapids, Michigan 49503 |
University of Minnesota Medical Center & Children's Hospital - Fairview | Minneapolis, Minnesota 55455 |
Stanford Comprehensive Cancer Center - Stanford | Stanford, California 94305 |
T.C. Thompson Children's Hospital | Chattanooga, Tennessee 37403 |
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham | Birmingham, Alabama 35294 |