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

Phase 2
30 Years
Not Enrolling

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Trial Information

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


- 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

Inclusion Criteria


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

- Not otherwise specified (NOS)

- Mixed cellularity NOS

- Lymphocytic depletion


- Diffuse fibrosis

- Reticular

- Lymphocytic predominance


- Diffuse

- Nodular

- Paragranuloma

- Granuloma

- Sarcoma

- Nodular sclerosis

- Cellular phase


- 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



- 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


- 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)


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

- ALT ≤ 2.5 times ULN


- 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)


- DLCO ≥ 50%

- FEV_1 ≥ 50%

- Vital capacity ≥ 50%

- No evidence of dyspnea at rest

- No exercise intolerance


- Not pregnant or nursing

- Negative pregnancy test

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

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

- No evidence of active graft-versus-host disease


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


- 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)


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered


- Not specified


- Concurrent immunosuppressive drugs allowed

Type of Study:


Study Design:

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

Outcome Measure:


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:


Principal Investigator

Peter Cole, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Federal Government

Study ID:




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



Roswell Park Cancer Institute Buffalo, New York  14263
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
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
Duke Comprehensive Cancer Center Durham, North Carolina  27710
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
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
Geisinger Medical Center Danville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
Newark Beth Israel Medical Center Newark, New Jersey  07112
New York Medical College Valhalla, New York  10595
University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis, Missouri  63110
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
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Children's Mercy Hospital Kansas City, Missouri  64108
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
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 Memorial Hospital - Chicago Chicago, Illinois  60614
Maine Children's Cancer Program Scarborough, Maine  04074-9308
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston, Massachusetts  02115
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Driscoll Children's Hospital Corpus Christi, Texas  78466
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
UCSF Comprehensive Cancer Center San Francisco, California  94115
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
East Tennessee Children's Hospital Knoxville, Tennessee  37901
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
Overlook Hospital Summit, New Jersey  07902-0220
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda, California  92354
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
Nemours Children's Clinic - Orlando Orlando, Florida  32806
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
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
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
Floating Hospital for Children at Tufts - New England Medical Center Boston, Massachusetts  02111
Breslin Cancer Center at Ingham Regional Medical Center Lansing, Michigan  48910
Children's Hospitals and Clinics of Minneapolis Minneapolis, Minnesota  55404
Hackensack University Medical Center Cancer Center Hackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of Medicine Bronx, New York  10461
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
Legacy Emanuel Hospital and Health Center & Children's Hospital Portland, Oregon  97227
Rhode Island Hospital Comprehensive Cancer Center Providence, Rhode Island  02903
Greenville Hospital System Cancer Center Greenville, South Carolina  29605
Texas Tech University Health Sciences Center School of Medicine - Amarillo Amarillo, Texas  79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390
Baylor University Medical Center - Houston Houston, Texas  77030-2399
Methodist Children's Hospital of South Texas San Antonio, Texas  78229-3993
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
Providence Cancer Center at Sacred Heart Medical Center Spokane, Washington  99220-2555
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division Charleston, West Virginia  25302
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
C.S. Mott Children's Hospital at University of Michigan Medical Center Ann Arbor, Michigan  48109-0286
St. Barnabas Medical Center Cancer Center Livingston, New Jersey  07039
Albany Medical Center Hospital Albany, New York  12208-3419
Tod Children's Hospital Youngstown, Ohio  44501
Oklahoma University Cancer Institute Oklahoma City, Oklahoma  73104
Madigan Army Medical Center - Tacoma Tacoma, Washington  98431
Mary Bridge Children's Hospital and Health Center - Tacoma Tacoma, Washington  98405
Spectrum Health Hospital - Butterworth Campus Grand Rapids, Michigan  49503
University of Minnesota Medical Center & Children's Hospital - Fairview Minneapolis, Minnesota  55455
Stanford Comprehensive Cancer Center - Stanford Stanford, California  94305
T.C. Thompson Children's Hospital Chattanooga, Tennessee  37403
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham Birmingham, Alabama  35294