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Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00006760
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 26, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Lymphoma Biological: filgrastim Drug: ifosfamide Drug: vinorelbine tartrate Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Re-Induction Chemotherapy With Ifosfamide, and Vinorelbine (IV) in Children With Refractory/Relapsed Hodgkin's Disease
Study Start Date : May 2001
Actual Primary Completion Date : July 2005
Actual Study Completion Date : March 2012


Arm Intervention/treatment
Experimental: 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.
Biological: filgrastim
subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover.

Drug: ifosfamide
V over 24 hours on days 1-4

Drug: vinorelbine tartrate
IV over 6-10 minutes on days 1 and 5.




Primary Outcome Measures :
  1. Overall response rate [ Time Frame: After 2 cycles ]
    Overall response includes complete response (CR) or partial response (PR).


Secondary Outcome Measures :
  1. Rate of successful PBSC harvest during re-induction defined as the ability to harvest 5 x 10^6 CD34+ cells/kg [ Time Frame: After 2 cycles ]
    Will be calculated.

  2. Biologic markers [ Time Frame: At enrollment and during/after therapy ]
  3. Cardiac, hepatic, renal, hematologic toxicity [ Time Frame: Within 1 month of completion of therapy ]
  4. Toxic death [ Time Frame: Within 1 month of Completion of therapy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006760


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Locations
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United States, Alabama
Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016-7710
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Southern California Permanente Medical Group
Downey, California, United States, 90242-2814
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States, 90801
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Children's Hospital Central California
Madera, California, United States, 93638-8762
Children's Hospital of Orange County
Orange, California, United States, 92868
Sutter Cancer Center
Sacramento, California, United States, 95816
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States, 95825
Children's Hospital and Health Center - San Diego
San Diego, California, United States, 92123-4282
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
Children's Hospital Cancer Center
Denver, Colorado, United States, 80218-1088
United States, Connecticut
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States, 06360-2875
United States, Delaware
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19899
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Florida
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States, 33901
University of Florida Shands Cancer Center
Gainesville, Florida, United States, 32610-0232
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Miami Children's Hospital
Miami, Florida, United States, 33155
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
M.D. Anderson Cancer Center - Orlando
Orlando, Florida, United States, 32806
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States, 32504
All Children's Hospital
St. Petersburg, Florida, United States, 33701
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States, 33607
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
United States, Georgia
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 95813
United States, Idaho
St. Luke's Mountain States Tumor Institute - Boise
Boise, Idaho, United States, 83712-6297
United States, Illinois
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9620
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Blank Children's Hospital
Des Moines, Iowa, United States, 50309
United States, Kansas
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
Kosair Children's Hospital
Louisville, Kentucky, United States, 40232
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
United States, Maine
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074-9308
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Hurley Medical Center
Flint, Michigan, United States, 48503
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States, 49503-2560
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-5341
United States, Minnesota
Children's Hospital of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
Keesler Medical Center - Keesler Air Force Base
Keesler AFB, Mississippi, United States, 39534-2511
United States, Missouri
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States, 65203
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
United States, New Jersey
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
St. Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Brooklyn Hospital Center
Brooklyn, New York, United States, 11201-5493
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States, 11794-8174
SUNY Upstate Medical University Hospital
Syracuse, New York, United States, 13210
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States, 28233-3549
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308-1062
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106-5000
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195-5217
Children's Medical Center - Dayton
Dayton, Ohio, United States, 45404-1815
Toledo Hospital
Toledo, Ohio, United States, 43606
United States, Oklahoma
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Institute of Oncology at Vilnius University
Portland, Oregon, United States, 97227
United States, Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Greenville Hospital System Cancer Center
Greenville, South Carolina, United States, 29605
United States, Tennessee
T.C. Thompson Children's Hospital
Chattanooga, Tennessee, United States, 37403
United States, Texas
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States, 79106
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104-9958
Baylor University Medical Center - Houston
Houston, Texas, United States, 77030-2399
Covenant Children's Hospital
Lubbock, Texas, United States, 79410
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113-1100
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
INOVA Fairfax Hospital
Fairfax, Virginia, United States, 22031
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States, 23507-1971
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0037
Carilion Cancer Center of Western Virginia
Roanoke, Virginia, United States, 24029
United States, Washington
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States, 98105
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States, 98431
United States, West Virginia
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
United States, Wisconsin
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Prince of Wales Private Hospital
Randwick, New South Wales, Australia, 2031
Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Western Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia, 6001
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
Canada, British Columbia
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Montreal Children's Hospital at McGill University Health Center
Montreal, Quebec, Canada, H3H 1P3
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, Canada, G1V 4G2
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Tanya Trippett, MD Memorial Sloan Kettering Cancer Center
Study Chair: Pedro A. de Alarcon, MD St. Jude Children's Research Hospital

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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00006760     History of Changes
Other Study ID Numbers: AHOD00P1
CCG-A5981 ( Other Identifier: Children's Cancer Group )
CDR0000068325 ( Other Identifier: Clinical Trials.gov )
NCI-2012-02366 ( Other Identifier: NCI )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 26, 2013
Last Verified: July 2013
Keywords provided by Children's Oncology Group:
recurrent/refractory childhood Hodgkin lymphoma
childhood lymphocyte predominant Hodgkin lymphoma
childhood lymphocyte depletion Hodgkin lymphoma
childhood nodular sclerosis Hodgkin lymphoma
childhood mixed cellularity Hodgkin lymphoma
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vinorelbine
Ifosfamide
Isophosphamide mustard
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents