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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00026312 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without monoclonal antibody therapy, interleukin-2, and sargramostim following stem cell transplantation in treating neuroblastoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without monoclonal antibody, interleukin-2, and sargramostim following stem cell transplantation in treating patients who have neuroblastoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma |
Biological: aldesleukin Biological: monoclonal antibody Ch14.18 Biological: sargramostim Drug: isotretinoin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Phase III Randomized Study Of Chimeric Antibody 14.18 (CH14.18) In High Risk Neuroblastoma Following Myeloablative Therapy And Autologous Stem Cell Rescue |
| Estimated Enrollment: | 423 |
| Study Start Date: | October 2001 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I (closed to accrual as of 4/16/2009): Active Comparator
Patients receive oral isotretinoin twice daily for 14 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
|
Drug: isotretinoin
Given orally
|
|
Arm II: Experimental
Patients receive immunotherapy comprising sargramostim (GM-CSF) subcutaneously (SC) or IV over 2 hours on days 0-13 during courses 1, 3, and 5 and monoclonal antibody Ch14.18 IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive interleukin-2 IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral isotretinoin as in arm I beginning on day 11 of immunotherapy.
|
Biological: aldesleukin
Given IV
Biological: monoclonal antibody Ch14.18
Given IV
Biological: sargramostim
Given subcutaneously or IV
Drug: isotretinoin
Given orally
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of neuroblastoma
Meets all of the following criteria:
Completed frontline therapies, examples of such therapy includes:
Tandem transplant patients are eligible
Must meet the International Neuroblastoma Response Criteria (INRC) for CR, VGPR, or PR for primary site, soft tissue metastases, and bone metastases AND must also meet the protocol specified criteria for bone marrow response as follows:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Creatinine adjusted according to age as follows:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| UAB Comprehensive Cancer Center | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| Contact: Clinical Trials Office - UAB Comprehensive Cancer Center 205-934-0309 | |
| United States, Arizona | |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Recruiting |
| Tucson, Arizona, United States, 85724-5024 | |
| Contact: Clinical Trials Office - Arizona Cancer Center at University o 520-626-9008 | |
| Phoenix Children's Hospital | Recruiting |
| Phoenix, Arizona, United States, 85016-7710 | |
| Contact: Jessica L. Boklan 602-546-0920 | |
| United States, California | |
| Children's Hospital and Research Center Oakland | Recruiting |
| Oakland, California, United States, 94609 | |
| Contact: Clinical Trial Office - Children's Hospital and Research Cente 510-450-7600 | |
| Children's Hospital Central California | Recruiting |
| Madera, California, United States, 93638-8762 | |
| Contact: Vonda L. Crouse 559-353-5480 | |
| Childrens Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Leo Mascarenhas 323-361-2529 | |
| Children's Hospital of Orange County | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Violet Shen 714-532-8636 | |
| City of Hope Comprehensive Cancer Center | Recruiting |
| Duarte, California, United States, 91010-3000 | |
| Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org | |
| Jonathan Jaques Children's Cancer Center at Miller Children's Hospital | Recruiting |
| Long Beach, California, United States, 90801 | |
| Contact: Jerry Z. Finklestein 562-492-1062 | |
| University of California Davis Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Clinical Trials Office - University of California Davis Cancer 916-734-3089 | |
| Kaiser Permanente Medical Center - Oakland | Recruiting |
| Sacramento, California, United States, 95825 | |
| Contact: Vincent Kiley 916-474-2326 | |
| Loma Linda University Cancer Institute at Loma Linda University Medical Center | Recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Clinical Trials Office - Loma Linda University Cancer Institut 909-558-3375 | |
| Rady Children's Hospital - San Diego | Recruiting |
| San Diego, California, United States, 92123-4282 | |
| Contact: Clinical Trials Office - Rady Children's Hospital - San Diego 858-966-5934 | |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Recruiting |
| Los Angeles, California, United States, 90048-1865 | |
| Contact: Carole H. Hurvitz 310-423-4423 | |
| Southern California Permanente Medical Group | Recruiting |
| Downey, California, United States, 90027 | |
| Contact: Robert M. Cooper 323-783-5307 | |
| Stanford Cancer Center | Recruiting |
| Stanford, California, United States, 94305-5824 | |
| Contact: Clinical Trials Office - Stanford Cancer Center 650-498-7061 cctoffice@stanford.edu | |
| Sutter Cancer Center | Recruiting |
| Sacramento, California, United States, 95816 | |
| Contact: Clinical Trial Office - Sutter Cancer Center 916-454-6595 | |
| UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
| San Francisco, California, United States, 94115 | |
| Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
| Jonsson Comprehensive Cancer Center at UCLA | Recruiting |
| Los Angeles, California, United States, 90095-1781 | |
| Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 | |
| United States, Colorado | |
| Children's Hospital Center for Cancer and Blood Disorders | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Kelly Maloney 720-777-6673 | |
| Presbyterian - St. Luke's Medical Center | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Clinical Trials Office - Presbyterian - St. Luke's Medical Cen 303-839-6000 | |
| United States, Connecticut | |
| Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | Recruiting |
| Farmington, Connecticut, United States, 06360-2875 | |
| Contact: Clinical Trials Office - Carole and Ray Neag Comprehensive Can 800-579-7822 | |
| United States, Delaware | |
| Alfred I. duPont Hospital for Children | Recruiting |
| Wilmington, Delaware, United States, 19803 | |
| Contact: Clinical Trials Office - Alfred I. duPont Hospital for Childre 302-651-5755 | |
| United States, District of Columbia | |
| Children's National Medical Center | Recruiting |
| Washington, District of Columbia, United States, 20010-2970 | |
| Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549 | |
| United States, Florida | |
| Kaplan Cancer Center at St. Mary's Medical Center | Recruiting |
| West Palm Beach, Florida, United States, 33407 | |
| Contact: Narayana Gowda 561-844-6363 | |
| Baptist-South Miami Regional Cancer Program | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact: Doured Daghistani 305-274-1662 | |
| Broward General Medical Center Cancer Center | Recruiting |
| Fort Lauderdale, Florida, United States, 33316 | |
| Contact: Clinical Trials Office - Broward General Medical Center Cancer 954-355-5346 | |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Recruiting |
| Orlando, Florida, United States, 32803-1273 | |
| Contact: Clinical Trials Office - Florida Hospital Cancer Institute 407-303-5623 | |
| All Children's Hospital | Recruiting |
| St. Petersburg, Florida, United States, 33701 | |
| Contact: Gregory Hale 727-767-4176 | |
| Lee Cancer Care of Lee Memorial Health System | Recruiting |
| Fort Myers, Florida, United States, 33901 | |
| Contact: Clinical Trials Office - Lee Cancer Care of Lee Memorial Healt 877-680-0008 | |
| M.D. Anderson Cancer Center at Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Vincent F. Giusti 321-841-8588 | |
| Memorial Cancer Institute at Memorial Regional Hospital | Recruiting |
| Hollywood, Florida, United States, 33021 | |
| Contact: Clinical Trials Office - Memorial Cancer Institute 954-985-3443 | |
| Nemours Children's Clinic - Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Paul R. Gordon 407-650-7330 | |
| Nemours Children's Clinic | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Eric S. Sandler 904-697-3793 | |
| Sacred Heart Cancer Center at Sacred Heart Hospital | Recruiting |
| Pensacola, Florida, United States, 32504 | |
| Contact: Clinical Trials Office - Sacred Heart Cancer Center 850-416-4611 | |
| St. Joseph's Cancer Institute at St. Joseph's Hospital | Recruiting |
| Tampa, Florida, United States, 33607 | |
| Contact: Clinical Trials Office - St. Joseph's Cancer Institute 800-882-4123 | |
| University of Florida Shands Cancer Center | Recruiting |
| Gainesville, Florida, United States, 32610-0232 | |
| Contact: Clinical Trials Office - University of Florida Shands Cancer C 888-254-7581 | |
| United States, Georgia | |
| Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center | Recruiting |
| Savannah, Georgia, United States, 31403-3089 | |
| Contact: Clinical Trials Office - Curtis and Elizabeth Anderson Cancer 912-350-8568 | |
| Winship Cancer Institute of Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Howard M. Katzenstein 404-785-0853 | |
| United States, Hawaii | |
| Cancer Research Center of Hawaii | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Clinical Trials Office - Cancer Research Center of Hawaii 808-586-2979 | |
| United States, Illinois | |
| Children's Memorial Hospital - Chicago | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Stewart Goldman 773-880-3270 | |
| Saint Jude Midwest Affiliate | Recruiting |
| Peoria, Illinois, United States, 61637 | |
| Contact: Stephen D. Smith 309-624-4945 | |
| Simmons Cooper Cancer Institute | Recruiting |
| Springfield, Illinois, United States, 62794-9677 | |
| Contact: Clinical Trials Office - Simmons Cooper Cancer Institute 217-545-7929 | |
| University of Chicago Cancer Research Center | Recruiting |
| Chicago, Illinois, United States, 60637-1470 | |
| Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
| University of Illinois Cancer Center | Recruiting |
| Chicago, Illinois, United States, 60612-7243 | |
| Contact: Clinical Trial Office - University of Illinois Cancer Center 312-355-3046 | |
| United States, Indiana | |
| Indiana University Melvin and Bren Simon Cancer Center | Recruiting |
| Indianapolis, Indiana, United States, 46202-5289 | |
| Contact: Clinical Trials Office - Indiana University Cancer Center 317-274-2552 | |
| St. Vincent Indianapolis Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Clinical Trials Office - St. Vincent Indianapolis Hospital 317-338-2194 | |
| United States, Iowa | |
| Blank Children's Hospital | Recruiting |
| Des Moines, Iowa, United States, 50309 | |
| Contact: Clinical Trials Office - Blank Children's Hospital 515-241-6729 | |
| Holden Comprehensive Cancer Center at University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242-1002 | |
| Contact: Cancer Information Service 800-237-1225 | |
| United States, Kentucky | |
| Kosair Children's Hospital | Recruiting |
| Louisville, Kentucky, United States, 40232 | |
| Contact: Clinical Trials Office - Kosair Children's Hospital 502-629-5500 CancerResource@nortonhealthcare.org | |
| Lucille P. Markey Cancer Center at University of Kentucky | Recruiting |
| Lexington, Kentucky, United States, 40536-0093 | |
| Contact: Clinical Trials Office - Markey Cancer Center at University of 859-257-3379 | |
| United States, Louisiana | |
| Children's Hospital of New Orleans | Recruiting |
| New Orleans, Louisiana, United States, 70118 | |
| Contact: Clinical Trials Office - Children's Hospital of New Orleans 504-894-5377 | |
| Tulane Cancer Center Office of Clinical Research | Recruiting |
| Alexandria, Louisiana, United States, 71315-3198 | |
| Contact: Clinical Trials Office - Tulane Cancer Center 504-988-6121 | |
| United States, Maine | |
| CancerCare of Maine at Eastern Maine Medical Center | Recruiting |
| Bangor, Maine, United States, 04401 | |
| Contact: Clinical Trials Office - CancerCare of Maine 207-973-4274 | |
| United States, Maryland | |
| Alvin and Lois Lapidus Cancer Institute at Sinai Hospital | Recruiting |
| Baltimore, Maryland, United States, 21215 | |
| Contact: Joseph M. Wiley 410-601-5864 | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting |
| Baltimore, Maryland, United States, 21231-2410 | |
| Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |
| United States, Massachusetts | |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Recruiting |
| Springfield, Massachusetts, United States, 01199-0001 | |
| Contact: Satkiran S. Grewal 413-794-5316 | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Suzanne Shusterman 617-632-4901 | |
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | Recruiting |
| Detroit, Michigan, United States, 48201-1379 | |
| Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
| Breslin Cancer Center at Ingham Regional Medical Center | Recruiting |
| Lansing, Michigan, United States, 48910 | |
| Contact: Clinical Trials Office - Breslin Cancer Center at Ingham Regio 517-334-2765 | |
| Butterworth Hospital at Spectrum Health | Recruiting |
| Grand Rapids, Michigan, United States, 49503-2560 | |
| Contact: David S. Dickens 616-391-2086 | |
| C.S. Mott Children's Hospital at University of Michigan Medical Center | Recruiting |
| Ann Arbor, Michigan, United States, 48109-0286 | |
| Contact: Clinical Trials Office - C.S. Mott Children's Hospital 800-865-1125 | |
| CCOP - Kalamazoo | Recruiting |
| Kalamazoo, Michigan, United States, 49007-5381 | |
| Contact: Jeffrey S. Lobel 269-341-6350 | |
| Hurley Medical Center | Recruiting |
| Flint, Michigan, United States, 48503 | |
| Contact: Clinical Trials Office - Hurley Medical Center 810-762-8057 | |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Recruiting |
| Grosse Pointe Woods, Michigan, United States, 48236 | |
| Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo 313-343-3166 | |
| United States, Minnesota | |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Clinical Trials Office - Children's Hospitals and Clinics of M 612-813-5193 | |
| Masonic Cancer Center at University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
| Mayo Clinic Cancer Center | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
| United States, Mississippi | |
| University of Mississippi Cancer Clinic | Recruiting |
| Jackson, Mississippi, United States, 39216-4505 | |
| Contact: Gail C. Megason 601-984-5220 | |
| United States, Missouri | |
| Cardinal Glennon Children's Hospital | Recruiting |
| St. Louis, Missouri, United States, 63104 | |
| Contact: William S. Ferguson 314-577-5638 | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Maxine Hetherington 816-234-3265 | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Robert J. Hayashi 314-454-4118 | |
| United States, Nebraska | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | Recruiting |
| Omaha, Nebraska, United States, 68198-6805 | |
| Contact: Clinical Trials Office - UNMC Eppley Cancer Center at the Univ 800-999-5465 | |
| United States, Nevada | |
| CCOP - Nevada Cancer Research Foundation | Recruiting |
| Las Vegas, Nevada, United States, 89109-2306 | |
| Contact: Jonathan Bernstein 702-732-0971 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Contact: Clinical Trials Office - Norris Cotton Cancer Center 603-650-7609 cancerhelp@dartmouth.edu | |
| United States, New Jersey | |
| Hackensack University Medical Center Cancer Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Clinical Trials Office - Hackensack University Medical Center 201-996-2879 | |
| Newark Beth Israel Medical Center | Recruiting |
| Newark, New Jersey, United States, 07112 | |
| Contact: Clinical Trials Office - Newark Beth Israel Medical Center 973-926-3136 | |
| Saint Peter's University Hospital | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| Contact: Douglas A. Cipkala 732-745-6674 | |
| United States, New Mexico | |
| University of New Mexico Cancer Center | Recruiting |
| Albuquerque, New Mexico, United States, 87131-5636 | |
| Contact: Clinical Trials Office - University of New Mexico Cancer Cente 505-272-6972 | |
| United States, New York | |
| Albany Medical Center Hospital | Recruiting |
| Albany, New York, United States, 12208-3419 | |
| Contact: Vikramjit S. Kanwar 518-262-5513x25265 | |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: Clinical Trials Office - Albert Einstein Cancer Center at Albe 718-904-2730 aecc@aecom.yu.edu | |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Barbara L. Asselin 585-275-2981 | |
| Mount Sinai Medical Center | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Birte Wistinghausen 212-241-7022 | |
| New York Medical College | Recruiting |
| Valhalla, New York, United States, 10595 | |
| Contact: Fevzi Ozkaynak 914-493-7997 | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263-0001 | |
| Contact: Clinical Trials Office - Roswell Park Cancer Institute 877-275-7724 | |
| SUNY Upstate Medical University Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |
| Winthrop University Hospital | Recruiting |
| Mineola, New York, United States, 11501 | |
| Contact: Contact Person 516-663-9500 | |
| United States, North Carolina | |
| Blumenthal Cancer Center at Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States, 28232-2861 | |
| Contact: Clinical Trials Office - Blumenthal Cancer Center at Carolinas 704-355-2884 | |
| Duke Comprehensive Cancer Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Clinical Trials Office - Duke Comprehensive Cancer Center 888-275-3853 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 | |
| Mission Hospitals - Memorial Campus | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Contact: Clinical Trials Office - Mission Hospitals - Memorial Campus 828-213-4150 | |
| Presbyterian Cancer Center at Presbyterian Hospital | Recruiting |
| Charlotte, North Carolina, United States, 28233-3549 | |
| Contact: Clinical Trials Office - Presbyterian Cancer Center at Presbyt 704-384-5369 | |
| Wake Forest University Comprehensive Cancer Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Clinical Trials Office - Wake Forest University Comprehensive 336-713-6771 | |
| United States, Ohio | |
| Medical University of Ohio Cancer Center | Recruiting |
| Toledo, Ohio, United States, 43614 | |
| Contact: Clinical Trials Office - Medical University of Ohio Cancer Cen 419-383-6583 | |
| Children's Medical Center - Dayton | Recruiting |
| Dayton, Ohio, United States, 45404-1815 | |
| Contact: Emmett Broxson 937-641-3111 | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229-3039 | |
| Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-2799 | |
| Cleveland Clinic Taussig Cancer Center | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |
| Akron Children's Hospital | Recruiting |
| Akron, Ohio, United States, 44308-1062 | |
| Contact: Clinical Trials Office - Akron Children's Hospital 330-543-3193 | |
| Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205-2696 | |
| Contact: Amanda M. Termuhlen 614-722-3552 | |
| Rainbow Babies and Children's Hospital | Recruiting |
| Cleveland, Ohio, United States, 44106-5000 | |
| Contact: Yousif (Joe) H. Matloub 216-844-3345 | |
| Toledo Hospital | Recruiting |
| Toledo, Ohio, United States, 43606 | |
| Contact: Clinical Trials Office - Toledo Hospital 419-824-1842 | |
| United States, Oklahoma | |
| Oklahoma University Cancer Institute | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Rene Y. McNall-Knapp 405-271-5311 | |
| United States, Oregon | |
| Knight Cancer Institute at Oregon Health and Science University | Recruiting |
| Portland, Oregon, United States, 97239-3098 | |
| Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 503-494-1080 trials@ohsu.edu | |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | Recruiting |
| Portland, Oregon, United States, 97227 | |
| Contact: Clinical Trials Office - Legacy Emanuel Hospital and Health Ce 503-413-8199 | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104-9786 | |
| Contact: Richard Aplenc 267-426-7252 | |
| Children's Hospital of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Clinical Trials Office - Children's Hospital of Pittsburgh 412-692-5573 | |
| Geisinger Cancer Institute at Geisinger Health | Recruiting |
| Danville, Pennsylvania, United States, 17822-0001 | |
| Contact: Clinical Trials Office - Geisinger Cancer Institute 570-271-5251 | |
| Lehigh Valley Hospital - Muhlenberg | Recruiting |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Contact: Philip M. Monteleone 484-884-3333 | |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Contact: Clinical Trials Office - Penn State Cancer Institute at Milton 717-531-3779 CTO@hmc.psu.edu | |
| St. Christopher's Hospital for Children | Recruiting |
| Philadelphia, Pennsylvania, United States, 19134-1095 | |
| Contact: Clinical Trials Office - St. Christopher's Hospital for Childr 215-427-8991 | |
| United States, Rhode Island | |
| Rhode Island Hospital Comprehensive Cancer Center | Recruiting |
| Providence, Rhode Island, United States, 02903 | |
| Contact: Clinical Trials Office - Rhode Island Hospital Comprehensive C 401-444-1488 | |
| United States, South Carolina | |
| Greenville Hospital Cancer Center | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Contact: Clinical Trials Office - Greenville Hospital Cancer Center 864-241-6251 | |
| Palmetto Health South Carolina Cancer Center | Recruiting |
| Columbia, South Carolina, United States, 29203 | |
| Contact: Clinical Trials Office - Palmetto Health South Carolina Cancer 803-434-3680 | |
| United States, South Dakota | |
| Sanford Cancer Center at Sanford USD Medical Center | Recruiting |
| Sioux Falls, South Dakota, United States, 57117-5039 | |
| Contact: Clinical Trials Office - Sanford Cancer Center 605-328-1367 | |
| United States, Tennessee | |
| East Tennessee Children's Hospital | Recruiting |
| Knoxville, Tennessee, United States, 37901 | |
| Contact: Ray C. Pais 865-541-8266 | |
| St. Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Clinical Trials Office - St. Jude Children's Research Hospital 901-595-4644 | |
| T.C. Thompson Children's Hospital | Recruiting |
| Chattanooga, Tennessee, United States, 37403 | |
| Contact: Manoo G. Bhakta 423-778-7289 | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| United States, Texas | |
| Baylor University Medical Center - Houston | Recruiting |
| Houston, Texas, United States, 77030-2399 | |
| Contact: Patrick A. Thompson 832-824-4029 | |
| Cook Children's Medical Center - Fort Worth | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Contact: Clinical Trials Office - Cook's Children's Medical Center 682-885-2103 | |
| Covenant Children's Hospital | Recruiting |
| Lubbock, Texas, United States, 79410 | |
| Contact: Latha Prasannan 806-725-4840 | |
| Dell Children's Medical Center of Central Texas | Recruiting |
| Austin, Texas, United States, 78723 | |
| Contact: Clinical Trials Office - Dell Children's Medical Center of Cen 512-324-8022 | |
| Driscoll Children's Hospital | Recruiting |
| Corpus Christi, Texas, United States, 78411 | |
| Contact: Clinical Trials Office - Driscoll Children's Hospital 361-694-5311 | |
| Medical City Dallas Hospital | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Contact: Carl Lenarsky 972-566-6647x4439 | |
| Methodist Children's Hospital of South Texas | Recruiting |
| San Antonio, Texas, United States, 78229-3993 | |
| Contact: Michael S. Grimley 210-575-7268 | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097 | |
| United States, Utah | |
| Primary Children's Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84113-1100 | |
| Contact: Phillip E. Barnette 801-662-4700 | |
| United States, Vermont | |
| Fletcher Allen Health Care - University Health Center Campus | Recruiting |
| Burlington, Vermont, United States, 05401 | |
| Contact: Clinical Trials Office - Fletcher Allen Health Care 802-656-8990 | |
| United States, Virginia | |
| Children's Hospital of The King's Daughters | Recruiting |
| Norfolk, Virginia, United States, 23507-1971 | |
| Contact: Eric J. Lowe 757-668-7243 | |
| Inova Fairfax Hospital | Recruiting |
| Falls Church, Virginia, United States, 22042-3300 | |
| Contact: Clinical Trials Office - Inova Fairfax Hospital 703-208-6650 | |
| Naval Medical Center - Portsmouth | Recruiting |
| Portsmouth, Virginia, United States, 23708-2197 | |
| Contact: Clinical Trials Office - Naval Medical Center - Portsmouth 757-953-5939 | |
| University of Virginia Cancer Center | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Kimberly P. Dunsmore 434-924-5105 | |
| Virginia Commonwealth University Massey Cancer Center | Recruiting |
| Richmond, Virginia, United States, 23298-0037 | |
| Contact: Clinical Trials Office -Virginia Commonwealth University Masse 804-628-1939 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | Recruiting |
| Seattle, Washington, United States, 98105 | |
| Contact: Julie R. Park 206-987-2106 | |
| Providence Cancer Center at Sacred Heart Medical Center | Recruiting |
| Spokane, Washington, United States, 99220-2555 | |
| Contact: Judy L. Felgenhauer 509-474-2777 | |
| United States, Wisconsin | |
| Marshfield Clinic - Marshfield Center | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center 800-782-1581 ext. 94457 | |
| Midwest Children's Cancer Center at Children's Hospital of Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Michael E. Kelly 414-456-4170 | |
| St. Vincent Hospital Regional Cancer Center | Recruiting |
| Green Bay, Wisconsin, United States, 54307-3508 | |
| Contact: Clinical Trials Office - St. Vincent Hospital Regional Cancer 920-433-8889 | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
| Madison, Wisconsin, United States, 53792-6164 | |
| Contact: Clinical Trials Office - University of Wisconsin Paul P. Carbo 608-262-5223 | |
| Australia, New South Wales | |
| Westmead Institute for Cancer Research at Westmead Hospital | Recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Contact: Geoffrey B. McCowage 61298452122 | |
| Australia, Queensland | |
| Royal Children's Hospital | Recruiting |
| Brisbane, Queensland, Australia, 4029 | |
| Contact: Helen Irving 617-3636-8671 | |
| Australia, Victoria | |
| Royal Children's Hospital | Recruiting |
| Parkville, Victoria, Australia, 3052 | |
| Contact: David Ashley 61393455652 | |
| Australia, Western Australia | |
| Princess Margaret Hospital for Children | Recruiting |
| Perth, Western Australia, Australia, 6001 | |
| Contact: Catherine Cole 011-6189340-8238 | |
| Canada | |
| Centre Hospitalier Universitaire de Quebec | Recruiting |
| Quebec, Canada, G1V 4G2 | |
| Contact: Bruno Michon 418-656-4141X47191 | |
| Canada, Alberta | |
| Alberta Children's Hospital | Recruiting |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Contact: Douglas R. Strother 403-955-7272 | |
| University of Alberta Hospital | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Contact: Sunil Jayantilal` S. Desai 780-407-8829 | |
| Canada, British Columbia | |
| Children's & Women's Hospital of British Columbia | Recruiting |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Contact: Mason C. Bond 604-875-2322 | |
| Canada, Manitoba | |
| CancerCare Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Contact: Rochelle Yanofsky 204-787-4163 | |
| Canada, Newfoundland and Labrador | |
| Janeway Children's Health and Rehabilitation Centre | Recruiting |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Contact: John (Jack) P. Hand 709-777-4799 | |
| Canada, Nova Scotia | |
| IWK Health Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Contact: Margaret C. Yhap 902-470-8778 | |
| Canada, Ontario | |
| Children's Hospital of Eastern Ontario | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Contact: Jacqueline Halton 613-737-7600x2370 | |
| Children's Hospital of Western Ontario | Recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: A. E.L. Cairney 519-685-8494 | |
| Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Sylvain Baruchel 416-813-7795 | |
| McMaster Children's Hospital at Hamilton Health Sciences | Recruiting |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Contact: Carol A. Portwine 905-521-2100x73464 | |
| Canada, Quebec | |
| Hopital Sainte Justine | Recruiting |
| Montreal, Quebec, Canada, H3T 1C5 | |
| Contact: Yvan Samson 418-656-4141x47191 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre at the University of Saskatchewan | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Contact: Kaiser Ali 306-655-2744 | |
| Puerto Rico | |
| San Jorge Children's Hospital | Recruiting |
| Santurce, Puerto Rico, 00912 | |
| Contact: Luis A. Clavell 787-728-1575 | |
| Study Chair: | Alice L. Yu, MD, PhD | University of California, San Diego |
More Information
| Responsible Party: | Children's Oncology Group - Group Chair Office ( Gregory H. Reaman ) |
| Study ID Numbers: | CDR0000069018, COG-ANBL0032, COG-P9842 |
| Study First Received: | November 9, 2001 |
| Last Updated: | November 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00026312 History of Changes |
| Health Authority: | Unspecified |
|
regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma localized resectable neuroblastoma localized unresectable neuroblastoma |
|
Anti-Infective Agents Neuroectodermal Tumors, Primitive Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Neuroblastoma Antibodies, Monoclonal Anti-Retroviral Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Isotretinoin Dermatologic Agents |
Immunoglobulins Neoplasms by Histologic Type Anti-HIV Agents Antiviral Agents Pharmacologic Actions Neuroectodermal Tumors Antibodies Neoplasms Aldesleukin Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |