A Phase II Study of Navelbine (Vinorelbine) In Children With Recurrent Or Refractory Malignancies
Phase 2
N/A
21 Years
N/A
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors, Neuroblastoma, Sarcoma
Both
Brain and Central Nervous System Tumors, Neuroblastoma, Sarcoma
Trial Information
A Phase II Study of Navelbine (Vinorelbine) In Children With Recurrent Or Refractory Malignancies
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
John F. Kuttesch, PhD, MD
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000066106
NCT ID:
NCT00003234
Start Date:
May 1998
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- Neuroblastoma
- Sarcoma
- recurrent childhood rhabdomyosarcoma
- recurrent neuroblastoma
- recurrent childhood soft tissue sarcoma
- recurrent childhood supratentorial primitive neuroectodermal tumor
- recurrent childhood cerebellar astrocytoma
- recurrent childhood cerebral astrocytoma
- recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
- recurrent childhood ependymoma
- Nervous System Neoplasms
- Neuroblastoma
- Central Nervous System Neoplasms
- Sarcoma
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
| Chao Family Comprehensive Cancer Center | Orange, California 92868 |
| Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
| Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
| Rush-Presbyterian-St. Luke's Medical Center | Chicago, Illinois 60612 |
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
| Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
| University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
| University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
| Cancer Center of Albany Medical Center | Albany, New York 12208 |
| University of Rochester Cancer Center | Rochester, New York 14642 |
| State University of New York Health Sciences Center - Stony Brook | Stony Brook, New York 11790-7775 |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
| Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| Simmons Cancer Center - Dallas | Dallas, Texas 75235-9154 |
| University of California Davis Medical Center | Sacramento, California 95817 |
| Shands Hospital and Clinics, University of Florida | Gainesville, Florida 32610-100277 |
| Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
| Children's Hospital of Michigan | Detroit, Michigan 48201 |
| Hurley Medical Center | Flint, Michigan 48503 |
| Mount Sinai School of Medicine | New York, New York 10029 |
| Presbyterian Healthcare | Charlotte, North Carolina 28233-3549 |
| East Carolina University School of Medicine | Greenville, North Carolina 27858-4354 |
| Rhode Island Hospital | Providence, Rhode Island 02903 |
| Medical City Dallas Hospital | Dallas, Texas 75230 |
| San Antonio Military Pediatric Cancer and Blood Disorders Center | Lackland Air Force Base, Texas 78236-5300 |
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
| Vermont Cancer Center | Burlington, Vermont 05401-3498 |
| Midwest Children's Cancer Center | Milwaukee, Wisconsin 53226 |
| University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
| UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
| Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
| Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
| State University of New York - Upstate Medical University | Syracuse, New York 13210 |
| St. Vincent Hospital and Health Care Center | Indianapolis, Indiana 46260 |
| Yale Comprehensive Cancer Center | New Haven, Connecticut 06520-8028 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
| Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
| University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
| Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
| Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
| Lombardi Cancer Center | Washington, District of Columbia 20007 |
| Henry Ford Hospital | Detroit, Michigan 48202 |
| Boston Floating Hospital Infants and Children | Boston, Massachusetts 02111 |
| Loma Linda University Medical Center | Loma Linda, California 92354 |
| David Grant Medical Center | Travis Air Force Base, California 94535 |
| Baptist Hospital of Miami | Miami, Florida 33176-2197 |
| Tulane University School of Medicine | New Orleans, Louisiana 70112 |
| Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
| New York Medical College | Valhalla, New York 10595 |
| University of Texas Medical Branch | Galveston, Texas 77555-1329 |
| Naval Medical Center, Portsmouth | Portsmouth, Virginia 23708-2197 |
| Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Deaconess Medical Center | Spokane, Washington 99210-0248 |
| St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Cedars-Sinai Medical Center | Los Angeles, California 90048 |
| Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
| North Shore University Hospital | Manhasset, New York 11030 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
| Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
| Sutter Cancer Center | Sacramento, California 95816 |
| Medical College of Georgia Comprehensive Cancer Center | Augusta, Georgia 30912-4000 |
| Eastern Maine Medical Center | Bangor, Maine 04401 |
| Baystate Medical Center | Springfield, Massachusetts 01199 |
| Michigan State University | East Lansing, Michigan 48824 |
| William Beaumont Hospital | Royal Oak, Michigan 48073 |
| Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Children's Hospital Los Angeles | Los Angeles, California 90027-0700 |
| Children's Hospital of Orange County | Orange, California 92668 |
| Children's Hospital of Denver | Denver, Colorado 80218 |
| Children's National Medical Center | Washington, District of Columbia 20010-2970 |
| Children's Mercy Hospital | Kansas City, Missouri 64108 |
| St. Joseph's Hospital and Medical Center | Paterson, New Jersey 07503 |
| Children's Hospital Medical Center - Cincinnati | Cincinnati, Ohio 45229-3039 |
| Children's Hospital of Columbus | Columbus, Ohio 43205-2696 |
| Doernbecher Children's Hospital | Portland, Oregon 97201-3098 |
| Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| Children's Hospital and Regional Medical Center - Seattle | Seattle, Washington 98105 |
| University of South Alabama Medical Center | Mobile, Alabama 36604 |
| Kaiser Permanente Medical Center - Santa Clara | Santa Clara, California 95051-5386 |
| Broward General Medical Center | Fort Lauderdale, Florida 33316 |
| Children's Hospital of Southwest Florida | Fort Myers, Florida 33908 |
| Joe DiMaggio Children's Hospital at Memorial | Hollywood, Florida 33021 |
| Nemours Children's Clinic | Jacksonville, Florida 32207 |
| Miami Children's Hospital | Miami, Florida 33155-4069 |
| Nemours Children's Clinic-Orlando | Orlando, Florida 32806 |
| Sacred Heart Children's Hospital | Pensacola, Florida 32504 |
| All Children's Hospital | St. Petersburg, Florida 33701 |
| Tampa Children's Hospital | Tampa, Florida 33677-4227 |
| St. Mary's Hospital | West Palm Beach, Florida 33407 |
| Children's Healthcare of Atlanta - Scottish Rite | Atlanta, Georgia 30342 |
| Saint Jude Midwest Affiliate | Peoria, Illinois 61637 |
| Wesley Medical Center | Wichita, Kansas 67214 |
| Children's Hospital of New Orleans | New Orleans, Louisiana 70118 |
| Maine Children's Cancer Program | Scarborough, Maine 04074-9308 |
| St. John Hospital and Medical Center | Detroit, Michigan 48236 |
| Cardinal Glennon Children's Hospital | Saint Louis, Missouri 63104 |
| Schneider Children's Hospital | New Hyde Park, New York 11042 |
| Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| Legacy Emanuel Hospital and Health Center | Portland, Oregon 97227 |
| St. Christopher's Hospital for Children | Philadelphia, Pennsylvania 19134-1095 |
| Children's Hospital of Greenville Hospital System | Greenville, South Carolina 29605 |
| Cook Children's Medical Center - Fort Worth | Fort Worth, Texas 76104 |
| Scott and White Memorial Hospital | Temple, Texas 76508 |
| Inova Fairfax Hospital | Falls Church, Virginia 22042-3300 |
| West Virginia University - Charleston | Charleston, West Virginia 25302 |
| West Virginia University Hospitals | Morgantown, West Virginia 26506-9300 |
| Lutheran General Hospital | Park Ridge, Illinois 60068 |
| Mountain States Tumor Institute | Boise, Idaho 83712 |
| Phoenix Children's Hospital | Phoenix, Arizona 85016-7710 |
| Southern California Permanente Medical Group | Downey, California 90242 |
| Jonathan Jaques Children's Cancer Center | Long Beach, California 90801-1428 |
| Children's Hospital of Oakland | Oakland, California 94609-1809 |
| Lucile Packard Children's Hospital at Stanford | Palo Alto, California 94304 |
| Santa Barbara Cottage Hospital | Santa Barbara, California 93102 |
| Childhood Hematology/Oncology Associates | Denver, Colorado 80218 |
| Presbyterian-St Luke's Medical Center | Denver, Colorado 80218 |
| University of Connecticut Health Center | Farmington, Connecticut 06360-7106 |
| Alfred I. Dupont Institute | Wilmington, Delaware 19899 |
| Medical Center of Central Georgia | Macon, Georgia 31201 |
| Memorial Health University Medical Center, Inc. | Savannah, Georgia 31403-3089 |
| University of Illinois at Chicago | Chicago, Illinois 60612 |
| Hope Children's Hospital | Oak Lawn, Illinois 60453 |
| Southern Illinois University School of Medicine | Springfield, Illinois 62794-9658 |
| John Stoddard Cancer Center | Des Moines, Iowa 50309 |
| Raymond Blank Memorial Hospital for Children | Des Moines, Iowa 50308 |
| Kosair Children's Hospital | Louisville, Kentucky 40202-3830 |
| Ochsner Clinic | New Orleans, Louisiana 70121 |
| Mott Children's Hospital | Ann Arbor, Michigan 48109-0914 |
| Spectrum Health and DeVos Children's Hospital | Grand Rapids, Michigan 49503 |
| Children's Hospitals and Clinics - Minneapolis | Minneapolis, Minnesota 55404 |
| Children's Hospitals and Clinics of Minnesota | Saint Paul, Minnesota 55102 |
| St. Louis Children's Hospital | Saint Louis, Missouri 63110 |
| Children's Hospital of Omaha | Omaha, Nebraska 68114 |
| Sunrise Hospital and Medical Center | Las Vegas, Nevada 89109-2306 |
| Atlantic Health System | Summit, New Jersey 07901 |
| Brookdale University Hospital and Medical Center | Brooklyn, New York 11212 |
| Brooklyn Hospital Center | Brooklyn, New York 11201 |
| State University of New York Health Science Center at Brooklyn College of Medicine | Brooklyn, New York 11203 |
| Maimonides Medical Center | Brooklyn, New York 11219 |
| Columbia Presbyterian Hospital | New York, New York 10032 |
| Mission Saint Joseph's Health System | Asheville, North Carolina 28801 |
| Dakota Cancer Institute | Fargo, North Dakota 58103-4940 |
| Children's Hospital Medical Center of Akron | Akron, Ohio 44308 |
| Children's Medical Center - Dayton | Dayton, Ohio 45404 |
| St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
| Toledo Children's Hospital | Toledo, Ohio 43601 |
| Forum Health-Tod Childrens Hospital | Youngstown, Ohio 44501 |
| Children's Hospital of Oklahoma | Oklahoma City, Oklahoma 73104 |
| Natalie Warren Bryant Cancer Center | Tulsa, Oklahoma 74136 |
| Sioux Valley Hospital | Sioux Falls, South Dakota 57117 |
| East Tennessee Children's Hospital | Knoxville, Tennessee 37901 |
| Saint Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
| Texas Tech University Health Sciences Center School of Medicine | Amarillo, Texas 79106 |
| Children's Hospital of Austin | Austin, Texas 78701 |
| Covenant Children's Hospital | Lubbock, Texas 79410 |
| Methodist Health Care System | San Antonio, Texas 78229-3902 |
| Children's Hospital of the King's Daughters | Norfolk, Virginia 23507 |
| Mary Bridge Children's Health Center | Tacoma, Washington 98415-0299 |
| Cabell-Huntington Hospital, Inc | Huntington, West Virginia 25701 |
| Bellin Memorial Hospital | Green Bay, Wisconsin 54301 |
| Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
| University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
| Children's Hospital and Health Center | San Diego, California 92123-4282 |
| Children's Memorial Hospital, Chicago | Chicago, Illinois 60614 |
| Kaiser Permanente-Southern California Permanente Medical Group | San Diego, California 92120 |
| Kaiser Permanente Medical Group - San Francisco | San Francisco, California 94115 |
| Montefiore Medical Center | Bronx, New York 10467-2490 |
| James H. Quillen College of Medicine | Johnson City, Tennessee 37614-0622 |
| Carilion Roanoke Community Hospital | Roanoke, Virginia 24013 |
| Group Health Cooperative of Puget Sound | Seattle, Washington 98112 |
| Duluth Clinic | Duluth, Minnesota 55805 |
| Valley Children's Hospital | Madera, California 93638 |
| University of Miami-Jackson Memorial Hospital Medical Center | Miami, Florida 33136 |
| Walt Disney Memorial Cancer Institute | Orlando, Florida 32803 |
| University Child Health Services Clinic | Rockford, Illinois 61104 |
| University of New Mexico School of Medicine | Albuquerque, New Mexico 87131 |
| Center for Cancer Treatment and Research | Columbia, South Carolina 29203 |
