Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkin's Lymphoma
NCT ID: NCT00006760
Last Updated: 2013-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2001-05-31
2012-03-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have refractory or relapsed Hodgkin's lymphoma.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (ifosfamide, vinorelbine, 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.
filgrastim
subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover.
ifosfamide
V over 24 hours on days 1-4
vinorelbine tartrate
IV over 6-10 minutes on days 1 and 5.
Interventions
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filgrastim
subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover.
ifosfamide
V over 24 hours on days 1-4
vinorelbine tartrate
IV over 6-10 minutes on days 1 and 5.
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed refractory or relapsed Hodgkin's lymphoma
* Mixed cellularity, not otherwise specified (NOS)
* Lymphocytic depletion, NOS
* Lymphocytic depletion, diffuse fibrosis
* Lymphocytic depletion, reticular
* Lymphocytic predominance, NOS
* Lymphocytic predominance, diffuse
* Lymphocytic predominance, nodular
* Hodgkin's paragranuloma NOS
* Hodgkin's granuloma
* Hodgkin's sarcoma
* Nodular sclerosis, NOS
* Nodular sclerosis, cellular phase
* Nodular sclerosis, lymphocytic predominance
* Nodular sclerosis, mixed cellularity
* Nodular sclerosis, lymphocytic depletion
* Other (type not specified)
* In first relapse
* Metastasis to bone marrow with granulocytopenia, anemia, and/or thrombocytopenia allowed
* Not enrolled on POG-9426 unless there is an extranodal site of recurrence
PATIENT CHARACTERISTICS:
Age:
* Under 30 at diagnosis
Performance status:
* Lansky 60-100% (for patients 16 years and under)
* Karnofsky 60-100% (for patients over 16 years)
Life expectancy:
* At least 2 months
Hematopoietic:
* See Disease Characteristics
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 75,000/mm\^3 (transfusion independent)
Hepatic:
* Bilirubin no greater than 1.5 times normal
* SGOT or SGPT less than 2.5 times normal
Renal:
* Creatinine no greater than 1.5 times normal
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Cardiovascular:
* Shortening fraction at least 27% by echocardiogram OR
* Ejection fraction at least 50% by gated radionuclide
Other:
* No other concurrent serious illness
* No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or any other component of study drugs
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunomodulating agents
Chemotherapy:
* At least 2 weeks since prior chemotherapy (3 weeks for nitrosoureas) and recovered
* No other concurrent anticancer chemotherapy
Endocrine therapy:
* No concurrent steroids
* No concurrent corticosteroids (e.g., dexamethasone)
Radiotherapy:
* Recovered from prior radiotherapy
Surgery:
* Not specified
30 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Tanya Trippett, MD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Pedro A. de Alarcon, MD
Role: STUDY_CHAIR
St. Jude Children's Research Hospital
Locations
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Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Southern California Permanente Medical Group
Downey, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital of Orange County
Orange, California, United States
Sutter Cancer Center
Sacramento, California, United States
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States
Children's Hospital and Health Center - San Diego
San Diego, California, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
Children's Hospital Cancer Center
Denver, Colorado, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States
M.D. Anderson Cancer Center - Orlando
Orlando, Florida, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States
University of Illinois Cancer Center
Chicago, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Blank Children's Hospital
Des Moines, Iowa, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
Children's Hospital of New Orleans
New Orleans, Louisiana, United States
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States
Maine Children's Cancer Program
Scarborough, Maine, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, 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
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Children's Hospital of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Keesler Medical Center - Keesler Air Force Base
Keesler Air Force Base, Mississippi, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, 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
Newark Beth Israel Medical Center
Newark, New Jersey, United States
Brooklyn Hospital Center
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, 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
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
New York Medical College
Valhalla, New York, 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
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Children's Medical Center - Dayton
Dayton, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States
Institute of Oncology at Vilnius University
Portland, Oregon, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Greenville Hospital System Cancer Center
Greenville, South Carolina, United States
T.C. Thompson Children's Hospital
Chattanooga, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
Baylor University Medical Center - Houston
Houston, Texas, United States
Covenant Children's Hospital
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
INOVA Fairfax Hospital
Fairfax, Virginia, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States
Carilion Cancer Center of Western Virginia
Roanoke, Virginia, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Prince of Wales Private Hospital
Randwick, New South Wales, Australia
Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Alberta Children's Hospital
Calgary, Alberta, Canada
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada
Hopital Sainte Justine
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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CCG-A5981
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000068325
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-02366
Identifier Type: OTHER
Identifier Source: secondary_id
AHOD00P1
Identifier Type: -
Identifier Source: org_study_id
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