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A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease


Phase 2
N/A
30 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease


OBJECTIVES:

- Determine the response rate of pediatric patients with recurrent or refractory
Hodgkin's lymphoma treated with gemcitabine and vinorelbine.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive vinorelbine IV over 6-10 minutes and gemcitabine IV over 100 minutes on
days 1 and 8. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day
9 and continuing for at least 7 days and until blood counts recover. Treatment repeats every
21 days for at least 2 courses in the absence of disease progression or unacceptable
toxicity. Patients with responding disease after 2 courses may proceed directly to stem cell
transplantation off study OR receive 2 additional courses. Patients with stable disease
after 2 courses receive at least 2 additional courses. Patients with continued stable or
responding disease (with no disease progression) after 4 courses may continue to receive
study treatment for up to 1 year or discontinue study for alternative therapy at the
discretion of the treating physician.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 13-26 patients will be accrued for this study within 1.5
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed Hodgkin's lymphoma* with any of the following histologies:

- Not otherwise specified (NOS)

- Mixed cellularity NOS

- Lymphocytic depletion

- NOS

- Diffuse fibrosis

- Reticular

- Lymphocytic predominance

- NOS

- Diffuse

- Nodular

- Paragranuloma

- Granuloma

- Sarcoma

- Nodular sclerosis

- Cellular phase

- NOS

- Lymphocytic predominance

- Mixed cellularity

- Lymphocytic depletion NOTE: *Disease metastatic to bone marrow with
granulocytopenia and/or thrombocytopenia is allowed, but is not evaluable
for hematological toxicity

- Measurable disease by clinical or radiographic criteria

- Relapsed or refractory to conventional therapy

- Received at least 2 prior cytotoxic chemotherapy regimens

- No stage IA or IIA nodal disease previously treated with any of the following:

- Radiotherapy only

- No more than 4 courses of prior chemotherapy

PATIENT CHARACTERISTICS:

Age

- 30 and under

Performance status

- Karnofsky 50-100% (over 16 years of age)

- Lansky 50-100% (16 and under) OR

- ECOG 0-2

Life expectancy

- At least 8 weeks

Hematopoietic

- See Disease Characteristics

- Absolute neutrophil count ≥ 750/mm^3

- Platelet count ≥ 75,000/mm^3 (transfusion independent, defined as ≥ 3 days since
prior platelet transfusion)

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT ≤ 2.5 times ULN

Renal

- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR

- Creatinine based on age as follows:

- No greater than 0.8 mg/dL (age 5 and under)

- No greater than 1.0 mg/dL (age 6 to 10)

- No greater than 1.2 mg/dL (age 11 to 15)

- No greater than 1.5 mg/dL (over age 15)

Pulmonary

- DLCO ≥ 50%

- FEV_1 ≥ 50%

- Vital capacity ≥ 50%

- No evidence of dyspnea at rest

- No exercise intolerance

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

- Seizure disorder allowed provided patient is on anticonvulsants and disorder is well
controlled

- No evidence of active graft-versus-host disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Recovered from prior immunotherapy

- At least 6 months since prior allogeneic stem cell transplantation (SCT)

- At least 7 days since prior biologic agents

- More than 3 months since prior autologous SCT

- More than 1 week since prior growth factors

- No concurrent immunomodulating agents

Chemotherapy

- See Disease Characteristics

- More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for
nitrosoureas) and recovered

- No prior gemcitabine and vinorelbine in combination (i.e., administered within 1 week
of each other)

- Prior gemcitabine or vinorelbine administered alone is allowed

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent steroids, including corticosteroids as an antiemetic or for control of
graft-versus-host disease

- Concurrent corticosteroids allowed only for the following indications:

- Adrenal crisis in patients with suppressed pituitary/adrenal response

- Noncardiogenic pulmonary edema

- Allergic reactions to amphotericin or transfusions treated with low-dose
hydrocortisone (less than 100 mg/m^2)

Radiotherapy

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

Surgery

- Not specified

Other

- Concurrent immunosuppressive drugs allowed

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity

Outcome Description:

Toxic death, Hepatic, cardiac or renal toxicity, Hematologic toxicity, pulmonary toxicity or other grade 3 or 4 toxicities from interventions.

Outcome Time Frame:

Up to 4 years.

Safety Issue:

Yes

Principal Investigator

Peter Cole, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Federal Government

Study ID:

AHOD0321

NCT ID:

NCT00070304

Start Date:

July 2004

Completion Date:

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
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
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
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
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
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
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Driscoll Children's HospitalCorpus Christi, Texas  78466
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
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
East Tennessee Children's HospitalKnoxville, Tennessee  37901
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
Overlook HospitalSummit, New Jersey  07902-0220
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
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
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
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
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
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
Floating Hospital for Children at Tufts - New England Medical CenterBoston, Massachusetts  02111
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Children's Hospitals and Clinics of MinneapolisMinneapolis, Minnesota  55404
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
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
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Greenville Hospital System Cancer CenterGreenville, South Carolina  29605
Texas Tech University Health Sciences Center School of Medicine - AmarilloAmarillo, Texas  79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
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
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn Arbor, Michigan  48109-0286
St. Barnabas Medical Center Cancer CenterLivingston, New Jersey  07039
Albany Medical Center HospitalAlbany, New York  12208-3419
Tod Children's HospitalYoungstown, Ohio  44501
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Madigan Army Medical Center - TacomaTacoma, Washington  98431
Mary Bridge Children's Hospital and Health Center - TacomaTacoma, Washington  98405
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
University of Minnesota Medical Center & Children's Hospital - FairviewMinneapolis, Minnesota  55455
Stanford Comprehensive Cancer Center - StanfordStanford, California  94305
T.C. Thompson Children's HospitalChattanooga, Tennessee  37403
Lurleen Wallace Comprehensive Cancer at University of Alabama-BirminghamBirmingham, Alabama  35294