Vinorelbine in Treating Children With Recurrent or Refractory Cancers

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00003234
Collaborator
National Cancer Institute (NCI) (NIH)
50
228
3
106
0.2
0

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating children with recurrent or refractory cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: vinorelbine tartrate
Phase 2

Detailed Description

OBJECTIVES: I. Determine the response rate of children with recurrent or refractory malignancies treated with vinorelbine. II. Assess the toxic effects of this drug in these children.

OUTLINE: Patients receive vinorelbine IV over 6-10 minutes weekly on weeks 1-6. Treatment repeats every 8 weeks for a total of 10 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 100 patients will be accrued for this study within 2 years.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Navelbine (Vinorelbine) In Children With Recurrent Or Refractory Malignancies
Study Start Date :
May 1, 1998
Actual Primary Completion Date :
Mar 1, 2006
Actual Study Completion Date :
Mar 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stratum 1 - Soft Tissue Sarcoma

See detailed description.

Drug: vinorelbine tartrate
Other Names:
  • Navelbine®
  • 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2,3,-dihydroxybutanedioate)
  • Experimental: Stratum 2 - CNS Tumors

    See detailed description.

    Drug: vinorelbine tartrate
    Other Names:
  • Navelbine®
  • 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2,3,-dihydroxybutanedioate)
  • Experimental: Stratum 3 - Neuroblastoma

    See detailed description.

    Drug: vinorelbine tartrate
    Other Names:
  • Navelbine®
  • 3',4'-didehydro-4'-deoxy-C'-norvincaleukoblastine [R-(R*,R*)-2,3,-dihydroxybutanedioate)
  • Outcome Measures

    Primary Outcome Measures

    1. Disease progression []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory solid malignant tumors of childhood including: Soft tissue sarcoma Rhabdomyosarcoma Nonrhabdomyosarcoma Extraosseous Ewing's sarcoma CNS tumors Astrocytoma Primitive neuroectodermal tumor Atypical teratoid/rhabdoid tumors Ependymoma Recurrent neuroblastoma Measurable disease No more than 2 prior treatment regimens

    PATIENT CHARACTERISTICS: Age: 21 and under at diagnosis Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: For patients with solid tumors (unless marrow involvement): Absolute neutrophil count (ANC) at least 1000/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (RBC transfusions allowed) For patients post bone marrow transplantation: ANC at least 1,000/mm3 Platelet count at least 50,000/mm3 (transfusion independent) Hemoglobin at least 10 g/dL (RBC transfusions allowed) Hepatic: Total bilirubin no greater than 1.5 times normal SGOT/SGPT less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Neurologic: Seizure disorder allowed if well controlled CNS toxicity no greater than grade 2

    PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since prior bone marrow transplantation No concurrent immunomodulating agents Chemotherapy: At least 2 weeks since prior chemotherapy (4 weeks for nitrosourea) and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent corticosteroids except for increased intracranial pressure due to CNS tumors Radiotherapy: At least 6 months since prior radiotherapy to craniospinal axis, spine, and/or more than 50% of the bony pelvis Concurrent radiotherapy to localized painful lesions allowed if at least one measurable lesion is not in radiation field Surgery: Not specified Other: No concurrent participation in another CCG, POG, or COG therapeutic study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294-3300
    2 University of South Alabama Medical Center Mobile Alabama United States 36617-2293
    3 Phoenix Children's Hospital Phoenix Arizona United States 85006
    4 Arizona Cancer Center Tucson Arizona United States 85724
    5 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    6 Southern California Permanente Medical Group Downey California United States 90242
    7 Cancer Center and Beckman Research Institute, City of Hope Duarte California United States 91010-3000
    8 University of California San Diego Cancer Center La Jolla California United States 92093-0658
    9 Loma Linda University Medical Center Loma Linda California United States 92354
    10 Jonathan Jaques Children's Cancer Center Long Beach California United States 90801-1428
    11 Children's Hospital Los Angeles Los Angeles California United States 90027-0700
    12 Cedars-Sinai Medical Center Los Angeles California United States 90048
    13 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    14 Valley Children's Hospital Madera California United States 93638
    15 Children's Hospital of Oakland Oakland California United States 94609
    16 Chao Family Comprehensive Cancer Center Orange California United States 92868
    17 Children's Hospital of Orange County Orange California United States 92868
    18 Lucile Packard Children's Hospital at Stanford Palo Alto California United States 94304
    19 Sutter Cancer Center Sacramento California United States 95816
    20 University of California Davis Medical Center Sacramento California United States 95817
    21 Kaiser Permanente-Southern California Permanente Medical Group San Diego California United States 92120
    22 Children's Hospital and Health Center San Diego California United States 92123-4282
    23 Kaiser Permanente Medical Group - San Francisco San Francisco California United States 94115
    24 UCSF Cancer Center and Cancer Research Institute San Francisco California United States 94143-0128
    25 Santa Barbara Cottage Hospital Santa Barbara California United States 93102
    26 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051-5386
    27 David Grant Medical Center Travis Air Force Base California United States 94535
    28 Childhood Hematology/Oncology Associates Denver Colorado United States 80218
    29 Children's Hospital of Denver Denver Colorado United States 80218
    30 Presbyterian-St Luke's Medical Center Denver Colorado United States 80218
    31 University of Connecticut Health Center Farmington Connecticut United States 06360-7106
    32 Yale Comprehensive Cancer Center New Haven Connecticut United States 06520-8028
    33 Alfred I. Dupont Institute Wilmington Delaware United States 19899
    34 Lombardi Cancer Center Washington District of Columbia United States 20007
    35 Children's National Medical Center Washington District of Columbia United States 20010-2970
    36 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    37 Broward General Medical Center Fort Lauderdale Florida United States 33316
    38 Children's Hospital of Southwest Florida Fort Myers Florida United States 33908
    39 Shands Hospital and Clinics, University of Florida Gainesville Florida United States 32610-100277
    40 Joe DiMaggio Children's Hospital at Memorial Hollywood Florida United States 33021
    41 Nemours Children's Clinic Jacksonville Florida United States 32207
    42 University of Miami-Jackson Memorial Hospital Medical Center Miami Florida United States 33136
    43 Miami Children's Hospital Miami Florida United States 33155
    44 Baptist Hospital of Miami Miami Florida United States 33176-2197
    45 Walt Disney Memorial Cancer Institute Orlando Florida United States 32803
    46 Nemours Children's Clinic-Orlando Orlando Florida United States 32806
    47 Sacred Heart Children's Hospital Pensacola Florida United States 32504
    48 All Children's Hospital St. Petersburg Florida United States 33701
    49 Tampa Children's Hospital Tampa Florida United States 33677-4227
    50 St. Mary's Hospital West Palm Beach Florida United States 33407
    51 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    52 Children's Healthcare of Atlanta - Scottish Rite Atlanta Georgia United States 30342
    53 Medical College of Georgia Comprehensive Cancer Center Augusta Georgia United States 30912-4000
    54 Medical Center of Central Georgia Macon Georgia United States 31201
    55 Memorial Health University Medical Center, Inc. Savannah Georgia United States 31403-3089
    56 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
    57 Tripler Army Medical Center Honolulu Hawaii United States 96859-5000
    58 Mountain States Tumor Institute Boise Idaho United States 83712
    59 Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois United States 60612
    60 University of Illinois at Chicago Chicago Illinois United States 60612
    61 Children's Memorial Hospital, Chicago Chicago Illinois United States 60614
    62 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    63 Hope Children's Hospital Oak Lawn Illinois United States 60453
    64 Lutheran General Hospital Park Ridge Illinois United States 60068
    65 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
    66 University Child Health Services Clinic Rockford Illinois United States 61104
    67 Southern Illinois University School of Medicine Springfield Illinois United States 62794-9230
    68 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    69 St. Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
    70 Raymond Blank Memorial Hospital for Children Des Moines Iowa United States 50308
    71 John Stoddard Cancer Center Des Moines Iowa United States 50309
    72 Holden Comprehensive Cancer Center at The University of Iowa Iowa City Iowa United States 52242-1009
    73 Wesley Medical Center Wichita Kansas United States 67214
    74 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    75 Kosair Children's Hospital Louisville Kentucky United States 40232
    76 Tulane University School of Medicine New Orleans Louisiana United States 70112
    77 Children's Hospital of New Orleans New Orleans Louisiana United States 70118
    78 Ochsner Clinic New Orleans Louisiana United States 70121
    79 Eastern Maine Medical Center Bangor Maine United States 04401
    80 Maine Children's Cancer Program Scarborough Maine United States 04074
    81 Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland United States 21201
    82 Sinai Hospital of Baltimore Baltimore Maryland United States 21225
    83 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    84 Boston Floating Hospital Infants and Children Boston Massachusetts United States 02111
    85 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    86 Baystate Medical Center Springfield Massachusetts United States 01199
    87 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    88 Mott Children's Hospital Ann Arbor Michigan United States 48109
    89 Children's Hospital of Michigan Detroit Michigan United States 48201
    90 Henry Ford Hospital Detroit Michigan United States 48202
    91 St. John Hospital and Medical Center Detroit Michigan United States 48236
    92 Michigan State University East Lansing Michigan United States 48824
    93 Hurley Medical Center Flint Michigan United States 48503
    94 Spectrum Health and DeVos Children's Hospital Grand Rapids Michigan United States 49503
    95 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    96 William Beaumont Hospital Royal Oak Michigan United States 48073
    97 Duluth Clinic Duluth Minnesota United States 55805
    98 Children's Hospitals and Clinics - Minneapolis Minneapolis Minnesota United States 55404
    99 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    100 Children's Hospitals and Clinics of Minnesota Saint Paul Minnesota United States 55102
    101 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    102 Children's Mercy Hospital Kansas City Missouri United States 64108
    103 Cardinal Glennon Children's Hospital Saint Louis Missouri United States 63104
    104 St. Louis Children's Hospital Saint Louis Missouri United States 63110
    105 Children's Hospital of Omaha Omaha Nebraska United States 68114
    106 University of Nebraska Medical Center Omaha Nebraska United States 68198-3330
    107 Sunrise Hospital and Medical Center Las Vegas Nevada United States 89109-2306
    108 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756-0002
    109 Hackensack University Medical Center Hackensack New Jersey United States 07601
    110 Cancer Institute of New Jersey New Brunswick New Jersey United States 08901
    111 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    112 St. Joseph's Hospital and Medical Center Paterson New Jersey United States 07503
    113 Atlantic Health System Summit New Jersey United States 07901
    114 University of New Mexico School of Medicine Albuquerque New Mexico United States 87131
    115 Cancer Center of Albany Medical Center Albany New York United States 12208
    116 Montefiore Medical Center Bronx New York United States 10467-2490
    117 Brooklyn Hospital Center Brooklyn New York United States 11201
    118 State University of New York Health Science Center at Brooklyn College of Medicine Brooklyn New York United States 11203
    119 Brookdale University Hospital and Medical Center Brooklyn New York United States 11212
    120 Maimonides Medical Center Brooklyn New York United States 11219
    121 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    122 North Shore University Hospital Manhasset New York United States 11030
    123 Schneider Children's Hospital New Hyde Park New York United States 11042
    124 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    125 New York Presbyterian Hospital - Cornell Campus New York New York United States 10021
    126 Mount Sinai School of Medicine New York New York United States 10029
    127 Columbia Presbyterian Hospital New York New York United States 10032
    128 University of Rochester Cancer Center Rochester New York United States 14642
    129 State University of New York Health Sciences Center - Stony Brook Stony Brook New York United States 11790-7775
    130 State University of New York - Upstate Medical University Syracuse New York United States 13210
    131 New York Medical College Valhalla New York United States 10595
    132 Mission Saint Joseph's Health System Asheville North Carolina United States 28801
    133 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    134 Carolinas Medical Center Charlotte North Carolina United States 28232-2861
    135 Presbyterian Healthcare Charlotte North Carolina United States 28233-3549
    136 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    137 East Carolina University School of Medicine Greenville North Carolina United States 27858-4354
    138 Dakota Cancer Institute Fargo North Dakota United States 58108-6001
    139 Children's Hospital Medical Center of Akron Akron Ohio United States 44308
    140 Children's Hospital Medical Center - Cincinnati Cincinnati Ohio United States 45229-3039
    141 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    142 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    143 Children's Hospital of Columbus Columbus Ohio United States 43205-2696
    144 Children's Medical Center - Dayton Dayton Ohio United States 45404
    145 Toledo Children's Hospital Toledo Ohio United States 43601
    146 St. Vincent Mercy Medical Center Toledo Ohio United States 43608
    147 Forum Health-Tod Childrens Hospital Youngstown Ohio United States 44501
    148 Children's Hospital of Oklahoma Oklahoma City Oklahoma United States 73104
    149 Natalie Warren Bryant Cancer Center Tulsa Oklahoma United States 74136
    150 Doernbecher Children's Hospital Portland Oregon United States 97201-3098
    151 Legacy Emanuel Hospital and Health Center Portland Oregon United States 97227
    152 Geisinger Medical Center Danville Pennsylvania United States 17822-2001
    153 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    154 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    155 St. Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134-1095
    156 Children's Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15213
    157 Rhode Island Hospital Providence Rhode Island United States 02903
    158 Medical University of South Carolina Charleston South Carolina United States 29425-0721
    159 Center for Cancer Treatment and Research Columbia South Carolina United States 29203
    160 Children's Hospital of Greenville Hospital System Greenville South Carolina United States 29605
    161 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    162 Sioux Valley Hospital Sioux Falls South Dakota United States 57117
    163 James H. Quillen College of Medicine Johnson City Tennessee United States 37614-0622
    164 East Tennessee Children's Hospital Knoxville Tennessee United States 37901
    165 Saint Jude Children's Research Hospital Memphis Tennessee United States 38105-2794
    166 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6838
    167 Texas Tech University Health Sciences Center School of Medicine Amarillo Texas United States 79106
    168 Children's Hospital of Austin Austin Texas United States 78701
    169 Medical City Dallas Hospital Dallas Texas United States 75230
    170 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    171 Cook Children's Medical Center - Fort Worth Fort Worth Texas United States 76104
    172 University of Texas Medical Branch Galveston Texas United States 77555-0209
    173 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    174 Baylor College of Medicine Houston Texas United States 77030
    175 San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base Texas United States 78236-5300
    176 Covenant Children's Hospital Lubbock Texas United States 79410
    177 Methodist Health Care System San Antonio Texas United States 78229
    178 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284-7811
    179 Scott and White Memorial Hospital Temple Texas United States 76508
    180 Vermont Cancer Center Burlington Vermont United States 05401-3498
    181 Cancer Center at the University of Virginia Charlottesville Virginia United States 22908
    182 Inova Fairfax Hospital Falls Church Virginia United States 22042-3300
    183 Children's Hospital of the King's Daughters Norfolk Virginia United States 23507
    184 Naval Medical Center, Portsmouth Portsmouth Virginia United States 23708-2197
    185 Massey Cancer Center Richmond Virginia United States 23298-0037
    186 Carilion Roanoke Community Hospital Roanoke Virginia United States 24013
    187 Children's Hospital and Regional Medical Center - Seattle Seattle Washington United States 98105
    188 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-1024
    189 Group Health Cooperative of Puget Sound Seattle Washington United States 98112
    190 Deaconess Medical Center Spokane Washington United States 99210-0248
    191 Mary Bridge Children's Health Center Tacoma Washington United States 98405
    192 Madigan Army Medical Center Tacoma Washington United States 98431-5000
    193 West Virginia University - Charleston Charleston West Virginia United States 25302
    194 Cabell-Huntington Hospital, Inc Huntington West Virginia United States 25701
    195 West Virginia University Hospitals Morgantown West Virginia United States 26506-9300
    196 Bellin Memorial Hospital Green Bay Wisconsin United States 54301
    197 St. Vincent Hospital Green Bay Wisconsin United States 54307-3508
    198 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
    199 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792-0001
    200 Midwest Children's Cancer Center Milwaukee Wisconsin United States 53226
    201 Sydney Children's Hospital Randwick New South Wales Australia 2031
    202 Children's Hospital at Westmead Westmead New South Wales Australia 2145
    203 Royal Children's Hospital Brisbane Queensland Australia 4029
    204 Royal Children's Hospital Parkville Victoria Australia 3052
    205 Princess Margaret Hospital for Children Perth Western Australia Australia 6001
    206 Alberta Children's Hospital Calgary Alberta Canada T2T 5C7
    207 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    208 British Columbia Children's Hospital Vancouver British Columbia Canada V6H 3V4
    209 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9
    210 Janeway Children's Health and Rehabilitation Centre St. John's Newfoundland and Labrador Canada A1A 1R8
    211 IWK Health Centre Halifax Nova Scotia Canada B3J 3G9
    212 Children's Hospital Hamilton Ontario Canada L8N 3Z5
    213 Children's Hospital of Western Ontario London Ontario Canada N6C 2V5
    214 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
    215 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    216 McGill University Health Center - Montreal Children's Hospital Montreal Quebec Canada H3H 1P3
    217 Hopital Sainte Justine Montreal Quebec Canada H3T 1C5
    218 Centre Hospitalier de L'Universite Laval Sainte Foy Quebec Canada GIV 4G2
    219 Laval University Medical Center Sainte-Foy Quebec Canada G1V 4G2
    220 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    221 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4
    222 Academisch Ziekenhuis Groningen Groningen Netherlands 9713 EZ
    223 Starship Children's Hospital Auckland New Zealand
    224 University of Puerto Rico School of Medicine Medical Sciences Campus San Juan Puerto Rico 00936-5067
    225 San Jorge Childrens Hospital Santurce Puerto Rico 00912
    226 Swiss Pediatric Oncology Group Bern Bern Switzerland CH 3010
    227 Swiss Pediatric Oncology Group Geneva Geneva Switzerland CH 1211
    228 Swiss Pediatric Oncology Group Lausanne Lausanne Switzerland CH 1011

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: John F. Kuttesch, PhD, MD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00003234
    Other Study ID Numbers:
    • A09705
    • COG-A09705
    • CCG-09705
    • CDR0000066106
    First Posted:
    Oct 28, 2003
    Last Update Posted:
    Jul 28, 2014
    Last Verified:
    Jul 1, 2014

    Study Results

    No Results Posted as of Jul 28, 2014