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A Pilot Study of Re-Induction Chemotherapy With Ifosfamide, and Vinorelbine (IV) in Children With Refractory/Relapsed Hodgkin's Disease


Phase 2
N/A
30 Years
Not Enrolling
Both
Lymphoma

Thank you

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 InstituteBuffalo, New York  14263
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Hurley Medical CenterFlint, Michigan  48503
Medical City Dallas HospitalDallas, Texas  75230
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
Keesler Medical Center - Keesler Air Force BaseKeesler AFB, Mississippi  39534-2576
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
CCOP - Scott and White HospitalTemple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
St. Barnabas Medical CenterLivingston, New Jersey  07039
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Sutter Cancer CenterSacramento, California  95816
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Brooklyn Hospital CenterBrooklyn, New York  11201
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Children's Medical Center - DaytonDayton, Ohio  45404
Texas Tech University Health Sciences Center School of MedicineAmarillo, Texas  79106
Covenant Children's HospitalLubbock, Texas  79410
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Children's Hospital and Health Center - San DiegoSan Diego, California  92123-4282
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Sacred Heart Cancer Center at Sacred Heart HospitalPensacola, Florida  32504
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
St. Luke's Mountain States Tumor Institute - BoiseBoise, Idaho  83712-6297
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Blank Children's HospitalDes Moines, Iowa  50309
CancerCare of Maine at Eastern Maine Medial CenterBangor, Maine  04401
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Spectrum Health Cancer Care - Butterworth CampusGrand Rapids, Michigan  49503-2560
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Toledo HospitalToledo, Ohio  43606
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Greenville Hospital System Cancer CenterGreenville, South Carolina  29605
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
Carilion Cancer Center of Western VirginiaRoanoke, Virginia  24029
Edwards Comprehensive Cancer Center at Cabell Huntington HospitalHuntington, West Virginia  25701
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Madigan Army Medical Center - TacomaTacoma, Washington  98431
Children's Hospital Cancer CenterDenver, Colorado  80218
University of Virginia Cancer CenterCharlottesville, Virginia  22908
M.D. Anderson Cancer Center - OrlandoOrlando, Florida  32806
Institute of Oncology at Vilnius UniversityPortland, Oregon  97227
Children's Hospital of Minnesota - MinneapolisMinneapolis, Minnesota  55404
T.C. Thompson Children's HospitalChattanooga, Tennessee  37403