Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkin's Lymphoma
- Conditions
- Lymphoma
- Interventions
- Registration Number
- NCT00006760
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as ifosfamide and vinorelbine, work in 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: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have refractory or relapsed Hodgkin's lymphoma.
- Detailed Description
OBJECTIVES:
* Determine the response rate (overall and within strata) in both minimally pretreated, low-risk and heavily pretreated, high-risk children with refractory or relapsed Hodgkin's lymphoma treated with ifosfamide and vinorelbine with filgrastim (G-CSF).
* Determine the cardiac, hepatic, renal, and hematologic toxicity of this regimen in minimally-pretreated, low-risk patients.
* Determine the toxic death rate in minimally pretreated, low-risk patients treated with this regimen.
* Determine whether this treatment regimen can mobilize sufficient hematopoietic stem cells (CD34) for subsequent stem cell transplantation in minimally pretreated, low-risk patients.
* Determine the incidence of hypermutability by longitudinal genotoxic biomonitoring of patients treated with this regimen.
* Determine the prognostic significance of biological markers, including serum interleukin (IL)-10 receptor, serum IL-2 receptor, p53, and mdm-2 in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified by prior therapy (minimally pretreated, low-risk vs heavily pretreated, high-risk).
Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine IV over 6-10 minutes on days 1 and 5. Patients also receive filgrastim (G-CSF) subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive a third course of therapy at the discretion of the investigator.
Heavily pretreated, high-risk patients who achieve a complete response are eligible for stem cell transplantation. Patients undergo peripheral blood stem cell (PBSC) collection during hematopoietic recovery after the second course of chemotherapy. Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121.
Patients are followed at 1, 6, and 12 months and then periodically thereafter.
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study within 1.5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (ifosfamide, vinorelbine, filgrastim) filgrastim Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine tartrate IV over 6-10 minutes on days 1 and 5. Patients also receive filgrastim (G-CSF) subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive a third course of therapy at the discretion of the investigator. Heavily pretreated, high-risk patients who achieve a complete response are eligible for stem cell transplantation. Patients undergo peripheral blood stem cell (PBSC) collection during hematopoietic recovery after the second course of chemotherapy. Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121. Treatment (ifosfamide, vinorelbine, filgrastim) vinorelbine tartrate Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine tartrate IV over 6-10 minutes on days 1 and 5. Patients also receive filgrastim (G-CSF) subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive a third course of therapy at the discretion of the investigator. Heavily pretreated, high-risk patients who achieve a complete response are eligible for stem cell transplantation. Patients undergo peripheral blood stem cell (PBSC) collection during hematopoietic recovery after the second course of chemotherapy. Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121. Treatment (ifosfamide, vinorelbine, filgrastim) ifosfamide Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine tartrate IV over 6-10 minutes on days 1 and 5. Patients also receive filgrastim (G-CSF) subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive a third course of therapy at the discretion of the investigator. Heavily pretreated, high-risk patients who achieve a complete response are eligible for stem cell transplantation. Patients undergo peripheral blood stem cell (PBSC) collection during hematopoietic recovery after the second course of chemotherapy. Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121.
- Primary Outcome Measures
Name Time Method Overall response rate After 2 cycles Overall response includes complete response (CR) or partial response (PR).
- Secondary Outcome Measures
Name Time Method Rate of successful PBSC harvest during re-induction defined as the ability to harvest 5 x 10^6 CD34+ cells/kg After 2 cycles Will be calculated.
Biologic markers At enrollment and during/after therapy Cardiac, hepatic, renal, hematologic toxicity Within 1 month of completion of therapy Toxic death Within 1 month of Completion of therapy
Trial Locations
- Locations (114)
University of Illinois Cancer Center
🇺🇸Chicago, Illinois, United States
Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
All Children's Hospital
🇺🇸St. Petersburg, Florida, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
CancerCare of Maine at Eastern Maine Medial Center
🇺🇸Bangor, Maine, United States
Maine Children's Cancer Program
🇺🇸Scarborough, Maine, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
🇺🇸Lexington, Kentucky, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Children's Hospital of New Orleans
🇺🇸New Orleans, Louisiana, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
St. Luke's Mountain States Tumor Institute - Boise
🇺🇸Boise, Idaho, United States
Lee Cancer Care of Lee Memorial Health System
🇺🇸Fort Myers, Florida, United States
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Stanford Cancer Center at Stanford University Medical Center
🇺🇸Stanford, California, United States
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
🇺🇸Long Beach, California, United States
Blank Children's Hospital
🇺🇸Des Moines, Iowa, United States
Southern California Permanente Medical Group
🇺🇸Downey, California, United States
Kaplan Cancer Center at St. Mary's Medical Center
🇺🇸West Palm Beach, Florida, United States
CCOP - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Brooklyn Hospital Center
🇺🇸Brooklyn, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Carilion Cancer Center of Western Virginia
🇺🇸Roanoke, Virginia, United States
Keesler Medical Center - Keesler Air Force Base
🇺🇸Keesler AFB, Mississippi, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Hackensack University Medical Center Cancer Center
🇺🇸Hackensack, New Jersey, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Children's Hospital Medical Center of Akron
🇺🇸Akron, Ohio, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Children's & Women's Hospital of British Columbia
🇨🇦Vancouver, British Columbia, Canada
INOVA Fairfax Hospital
🇺🇸Fairfax, Virginia, United States
Madigan Army Medical Center - Tacoma
🇺🇸Tacoma, Washington, United States
Centre Hospitalier Universitaire de Quebec
🇨🇦Ste-Foy, Quebec, Canada
Covenant Children's Hospital
🇺🇸Lubbock, Texas, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
Marshfield Clinic - Marshfield Center
🇺🇸Marshfield, Wisconsin, United States
Massey Cancer Center at Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Alberta Children's Hospital
🇨🇦Calgary, Alberta, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Children's Hospital and Regional Medical Center - Seattle
🇺🇸Seattle, Washington, 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
Children's Hospital and Health Center - San Diego
🇺🇸San Diego, California, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Princess Margaret Hospital for Children
🇦🇺Perth, Western Australia, Australia
Primary Children's Medical Center
🇺🇸Salt Lake City, Utah, United States
New York Medical College
🇺🇸Valhalla, New York, United States
Children's Hospital of Orange County
🇺🇸Orange, California, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Oklahoma University Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Children's Hospital Cancer Center
🇺🇸Denver, Colorado, United States
Institute of Oncology at Vilnius University
🇺🇸Portland, Oregon, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
🇨🇦Montreal, Quebec, Canada
St. Joseph's Cancer Institute at St. Joseph's Hospital
🇺🇸Tampa, Florida, United States
Midwest Children's Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Long Island Cancer Center at Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Children's Hospital Central California
🇺🇸Madera, California, United States
Alfred I. duPont Hospital for Children
🇺🇸Wilmington, Delaware, United States
Nemours Children's Clinic
🇺🇸Jacksonville, Florida, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
🇺🇸Baltimore, Maryland, United States
Spectrum Health Cancer Care - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Children's Hospital of Minnesota - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
St. Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
NYU Cancer Institute at New York University Medical Center
🇺🇸New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
🇺🇸New York, New York, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Greenville Hospital System Cancer Center
🇺🇸Greenville, South Carolina, United States
Texas Tech University Health Sciences Center School of Medicine
🇺🇸Amarillo, Texas, United States
Cook Children's Medical Center - Fort Worth
🇺🇸Fort Worth, Texas, United States
Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Prince of Wales Private Hospital
🇦🇺Randwick, New South Wales, Australia
Allan Blair Cancer Centre at Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
Hopital Sainte Justine
🇨🇦Montreal, Quebec, Canada
Westmead Institute for Cancer Research at Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
🇺🇸Columbia, Missouri, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Children's Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
🇺🇸Huntington, West Virginia, United States
T.C. Thompson Children's Hospital
🇺🇸Chattanooga, Tennessee, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Sutter Cancer Center
🇺🇸Sacramento, California, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Kaiser Permanente Medical Center - Oakland
🇺🇸Sacramento, California, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
M.D. Anderson Cancer Center - Orlando
🇺🇸Orlando, Florida, United States
Kosair Children's Hospital
🇺🇸Louisville, Kentucky, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Saskatoon Cancer Centre at the University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada