A Pilot Study of Re-Induction Chemotherapy With Ifosfamide, and Vinorelbine (IV) in Children With Refractory/Relapsed Hodgkin's Disease
N/A
30 Years
Both
Lymphoma
Trial Information
A Pilot Study of Re-Induction Chemotherapy With Ifosfamide, and Vinorelbine (IV) in Children With Refractory/Relapsed Hodgkin's Disease
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Cardiac, hepatic, or renal toxicity
Outcome Time Frame:
Up to 1 month after completion of study treatment
Safety Issue:
Yes
Principal Investigator
Tanya Trippett, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
AHOD00P1
NCT ID:
NCT00006760
Start Date:
May 2001
Completion Date:
March 2012
Related Keywords:
- Lymphoma
- 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
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| 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 |
| 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 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| 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 |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
| Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
| Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
| New York Medical College | Valhalla, New York 10595 |
| Keesler Medical Center - Keesler Air Force Base | Keesler AFB, Mississippi 39534-2576 |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | Columbia, Missouri 65203 |
| Long Island Cancer Center at Stony Brook University Hospital | Stony Brook, New York 11790-7775 |
| 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 |
| St. Barnabas Medical Center | Livingston, New Jersey 07039 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Sutter Cancer Center | Sacramento, California 95816 |
| Children's Hospital of Orange County | Orange, California 92668 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Mercy Hospital | Kansas City, Missouri 64108 |
| Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
| 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 Hospital of New Orleans | New Orleans, Louisiana 70118 |
| Maine Children's Cancer Program | Scarborough, Maine 04074-9308 |
| Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
| Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
| Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
| 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 |
| Texas Tech University Health Sciences Center School of Medicine | Amarillo, Texas 79106 |
| 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 |
| Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |
| Stanford Cancer Center at Stanford University Medical Center | Stanford, California 94305 |
| Comprehensive Cancer Center at University of Alabama at Birmingham | Birmingham, Alabama 35294 |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Long Beach, California 90801 |
| 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 |
| 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 |
| Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Savannah, Georgia 31403-3089 |
| St. Luke's Mountain States Tumor Institute - Boise | Boise, Idaho 83712-6297 |
| 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 |
| Spectrum Health Cancer Care - Butterworth Campus | Grand Rapids, Michigan 49503-2560 |
| Hackensack University Medical Center Cancer Center | Hackensack, New Jersey 07601 |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
| NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
| 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 |
| Toledo Hospital | Toledo, Ohio 43606 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| Greenville Hospital System Cancer Center | Greenville, South Carolina 29605 |
| Baylor University Medical Center - Houston | Houston, Texas 77030-2399 |
| Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
| Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
| Carilion Cancer Center of Western Virginia | Roanoke, Virginia 24029 |
| Edwards Comprehensive Cancer Center at Cabell Huntington Hospital | Huntington, West Virginia 25701 |
| 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 |
| University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
| Madigan Army Medical Center - Tacoma | Tacoma, Washington 98431 |
| Children's Hospital Cancer Center | Denver, Colorado 80218 |
| University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
| M.D. Anderson Cancer Center - Orlando | Orlando, Florida 32806 |
| Institute of Oncology at Vilnius University | Portland, Oregon 97227 |
| Children's Hospital of Minnesota - Minneapolis | Minneapolis, Minnesota 55404 |
| T.C. Thompson Children's Hospital | Chattanooga, Tennessee 37403 |
