Gemcitabine and Vinorelbine in Treating Young Patients With Recurrent or Refractory Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Registration Number
- NCT00070304
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and vinorelbine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with vinorelbine works in treating young patients with recurrent or refractory Hodgkin's lymphoma.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment gemcitabine hydrochloride Patients receive vinorelbine tartrate IV over 6-10 minutes and gemcitabine hydrochloride 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. Treatment vinorelbine tartrate Patients receive vinorelbine tartrate IV over 6-10 minutes and gemcitabine hydrochloride 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. Treatment filgrastim Patients receive vinorelbine tartrate IV over 6-10 minutes and gemcitabine hydrochloride 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.
- Primary Outcome Measures
Name Time Method Tumor Response Rate Up to 1 year Adequate tumor response is defined as achieving CR, VGPR or PR at any evaluation.
- Secondary Outcome Measures
Name Time Method Toxicities Up to 4 weeks following the completion of therapy Toxic death, hepatic, cardiac or renal toxicity, hematologic toxicity, pulmonary toxicity or other grade 3 or 4 toxicities
Trial Locations
- Locations (123)
St. Barnabas Medical Center Cancer Center
🇺🇸Livingston, New Jersey, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Lee Cancer Care of Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
University of New Mexico Cancer Research and Treatment Center
🇺🇸Albuquerque, New Mexico, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Breslin Cancer Center at Ingham Regional Medical Center
🇺🇸Lansing, Michigan, United States
Albany Medical Center Hospital
🇺🇸Albany, New York, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Siteman Cancer Center at Barnes-Jewish Hospital
🇺🇸St. Louis, Missouri, United States
Brooklyn Hospital Center
🇺🇸Brooklyn, New York, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec, Canada
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
🇺🇸Charleston, West Virginia, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
🇺🇸Indianapolis, Indiana, United States
Baylor University Medical Center - Houston
🇺🇸Houston, Texas, United States
Driscoll Children's Hospital
🇺🇸Corpus Christi, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
Children's Hospital and Health Center - San Diego
🇺🇸San Diego, California, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Stanford Comprehensive Cancer Center - Stanford
🇺🇸Stanford, California, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Children's Memorial Hospital - Chicago
🇺🇸Chicago, Illinois, United States
CancerCare of Maine at Eastern Maine Medial Center
🇺🇸Bangor, Maine, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
🇺🇸Baltimore, Maryland, United States
Floating Hospital for Children at Tufts - New England Medical Center
🇺🇸Boston, Massachusetts, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Tod Children's Hospital
🇺🇸Youngstown, Ohio, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Geisinger Medical Center
🇺🇸Danville, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
St. Christopher's Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Rhode Island Hospital Comprehensive Cancer Center
🇺🇸Providence, Rhode Island, United States
Greenville Hospital System Cancer Center
🇺🇸Greenville, South Carolina, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
T.C. Thompson Children's Hospital
🇺🇸Chattanooga, Tennessee, United States
East Tennessee Children's Hospital
🇺🇸Knoxville, Tennessee, United States
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine - Amarillo
🇺🇸Amarillo, Texas, United States
Covenant Children's Hospital
🇺🇸Lubbock, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Providence Cancer Center at Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Madigan Army Medical Center - Tacoma
🇺🇸Tacoma, Washington, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
CHUS-Hopital Fleurimont
🇨🇦Sherbrooke, Alberta, Canada
Children's & Women's Hospital of British Columbia
🇨🇦Vancouver, British Columbia, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada
San Jorge Children's Hospital
🇵🇷Santurce, Puerto Rico
Swiss Pediatric Oncology Group Geneva
🇨ðŸ‡Geneva, Switzerland
Children's Hospitals and Clinics of Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Medical Center & Children's Hospital - Fairview
🇺🇸Minneapolis, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Methodist Children's Hospital of South Texas
🇺🇸San Antonio, Texas, United States
UCSF Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
🇺🇸Birmingham, Alabama, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
🇺🇸Portland, Oregon, United States
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
Nemours Children's Clinic - Orlando
🇺🇸Orlando, Florida, United States
Blank Children's Hospital
🇺🇸Des Moines, Iowa, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
Hackensack University Medical Center Cancer Center
🇺🇸Hackensack, New Jersey, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
Spectrum Health Hospital - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
UMASS Memorial Cancer Center - University Campus
🇺🇸Worcester, Massachusetts, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Overlook Hospital
🇺🇸Morristown, New Jersey, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Sacramento, California, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
🇺🇸Ann Arbor, Michigan, United States
Mary Bridge Children's Hospital and Health Center - Tacoma
🇺🇸Tacoma, Washington, United States