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Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors Clinical research trials and Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors. Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors  Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
For Condition: childhood solid tumor,Osteosarcoma,childhood soft tissue sarcoma,Melanoma,Neuroblastoma
Status: Recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of hu14.18-interleukin-2 fusion protein in treating children who have refractory or recurrentneuroblastoma or other tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of hu14.18-interleukin-2 fusion protein in children with refractory or recurrent neuroblastoma or other GD2-positive tumors. - Determine the toxicity and pharmacokinetics of the fusion protein in these patients. - Determine the effect of the fusion protein on systemic immune modulation in these patients. - Quantitate the antifusion protein antibodies in patients treated with fusion protein. - Evaluate antitumor responses resulting from this fusion protein regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive hu14.18-interleukin-2 (hu14.18-IL2) fusion protein IV over 4 hours once daily on days 1-3. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of hu14.18-IL2 fusion protein until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 2 months for 1 year, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed neuroblastoma or melanoma at original diagnosis - Refractory to chemotherapy or recurrence after prior multiagent chemotherapy - Measurable or evaluable (detectable by bone scan) metastatic disease OR - No evidence of disease if complete response to prior surgical resection, radiotherapy, and/or chemotherapy OR - Histologically confirmed tumor expressing GD2 antigen at original diagnosis or relapse - Refractory to standard treatment - Measurable or evaluable disease by clinical assessments or laboratory markers OR - No evidence of disease after prior surgical resection of metastatic, recurrent disease - Histologically confirmed recurrent osteogenic sarcoma after prior chemotherapy allowed - Soft tissue sarcoma allowed - No primary CNS tumors - Prior CNS metastases allowed, provided: - Disease previously treated - Disease clinically stable for 4 weeks before study - At least 4 weeks since prior steroids for CNS metastases - No clinically detectable pleural effusions or ascites PATIENT CHARACTERISTICS: Age: - 21 and under Performance status: - Karnofsky 60-100% for children over age 10 - Lansky 60-100% for children age 10 and under Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count at least 75,000/mm^3 (transfusion allowed) - Hemoglobin at least 9.0 g/dL (transfusion allowed) Hepatic: - Bilirubin less than 1.5 mg/dL - ALT or AST no greater than 2.5 times normal - Hepatitis B surface antigen negative Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min Cardiovascular: - Shortening fraction at least 27% by echocardiogram OR - Ejection fraction more than 50% by MUGA scan - No congestive heart failure - No uncontrolled cardiac rhythm disturbance Pulmonary: - FEV - and FVC more than 60% of predicted OR - No dyspnea at rest - No exercise intolerance - Oxygen saturation more than 94% by pulse oximetry on room air Neurologic: - No seizure disorders requiring antiseizure medications - No significant neurologic deficit or grade 2 or greater objective peripheral neuropathy Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No significant concurrent illnesses unrelated to cancer or its treatment - No significant psychiatric disabilities - No uncontrolled active infections - No uncontrolled active peptic ulcer PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 1 week since prior growth factors - At least 1 week since prior immunomodulatory therapy - Prior monoclonal antibodies allowed if no detectable antibody to hu14.18 - Prior autologous bone marrow transplantation (BMT) or stem cell transplantation (SCT) allowed - Prior autologous BMT or SCT with monoclonal antibody-purged specimens allowed - No concurrent growth factors - No concurrent interferon Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or melphalan) - No concurrent palliative chemotherapy Endocrine therapy: - See Disease Characteristics - At least 2 weeks since prior glucocorticoids, except for life-threatening symptoms - No concurrent corticosteroids - No concurrent glucocorticoids, except for life-threatening symptoms Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy - No concurrent palliative radiotherapy Surgery: - See Disease Characteristics - At least 2 weeks since prior major surgery (e.g., laparotomy or thoracotomy) - No prior organ allografts - No concurrent palliative surgery Other: - Recovered from prior therapy - At least 1 week since prior tretinoin - At least 3 weeks since prior immunosuppressive therapy - No other concurrent immunosuppressive drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulSondel, Study Chair, University of Wisconsin Comprehensive Cancer Center
Children's Hospital of Michigan *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Yaddanapudi Ravindranath 313-745-5649
Children's Hospital of Orange County *Recruiting*
Orange, California, 92868
United States
Recruiting Wei-Ping Shen 714-532-8636
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-6164
United States
Recruiting Diane Puccetti 608-263-0320
University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio, Texas, 78207
United States
Recruiting Paul Thomas 210-704-3405
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Victor Blanchette 416-598-5852
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Nita Seibel 202-884-2144
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Joann Ater 713-792-6665
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Wayne Furman 901-495-3300
Cardinal Glennon Children's Hospital *Recruiting*
St. Louis, Missouri, 63104
United States
Recruiting Dennis O'Connor 314-577-5638
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus *Recruiting*
Atlanta, Georgia, 30342
United States
Recruiting Stephen Lauer 404-250-2781
Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425-0721
United States
Recruiting Julio Barredo 803-792-2957
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9063
United States
Recruiting Naomi Winick 214-648-3074
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Cindy Schwartz 410-955-2457
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting Judith Sato 626-930-5430
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-6838
United States
Recruiting James Whitlock 615-936-1762
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-0296
United States
Recruiting Stephen Hunger 352-392-5633
Children's Hospital of Columbus *Recruiting*
Columbus, Ohio, 43205-2696
United States
Recruiting Amanda Termuhlen 614-722-3552
Cook Children's Medical Center - Fort Worth *Recruiting*
Ft. Worth, Texas, 76104
United States
Recruiting Timothy Griffin 682-885-4020
Washington University Medical Center *Recruiting*
St. Louis, Missouri, 63105
United States
Recruiting Lori Luchtman-Jones 314-454-6018
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Holcombe Grier 617-632-3971
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Stephen Feig 310-825-5268
McGill University Health Center - Montreal Children's Hospital *Recruiting*
Montreal, Quebec, H3G 1A4
Canada
Recruiting Carolyn Freeman 514-412-8040
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Carola Arndt 507-284-4822
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Linda Granowetter 212-305-8652
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4215
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Philip Breitfeld 919-684-3377
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Aaron Rausen 212-263-7144
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting Dale Pullen 601-984-5220
Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City, Kansas, 66160-7357
United States
Recruiting Robert Trueworthy 913-588-6340
Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City, Oklahoma, 73126
United States
Recruiting William Meyer 405-271-4022
Arkansas Children's Hospital *Recruiting*
Little Rock, Arkansas, 72202-3591
United States
Recruiting Kimo Stine 501-364-1494
Hopital Sainte Justine *Recruiting*
Montreal, Quebec, H3T 1C5
Canada
Recruiting Albert Moghrabi 514-345-4969
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0914
United States
Recruiting Raymond Hutchinson 734-936-8785
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Ronald Dubowy 315-464-5294
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-3039
United States
Recruiting John Perentesis 513-636-6090
Floating Hospital for Children *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting Cynthia Kretschmar 617-636-5535
Royal Children's Hospital *Recruiting*
Parkville, Victoria, 3052
Australia
Recruiting David Ashley 61-39-345-5522
Cancer Center at Hackensack University Medical Center *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Michael Harris 201-996-5437
University of Arkansas for Medical Sciences *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting David Becton 501-320-5650
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Katherine Matthay 415-353-9510
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027-0700
United States
Recruiting Paul Gaynon 323-669-2163
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Huntsman Cancer Institute *Recruiting*
Salt Lake City, Utah, 84112
United States
Recruiting Carol Bruggers 801-585-0303
Stanford Cancer Center at Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5208
United States
Recruiting Michael Link 650-723-5535
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Robert Fallon 317-274-8784
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting Douglas Hawkins 206-987-3096
Midwest Children's Cancer Center *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Bruce Camitta 414-456-4118
Children's Memorial Hospital - Chicago *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Susan Cohn 773-880-4562
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Peter Steinherz 212-639-7951
Rebecca and John Moores UCSD Cancer Center *Recruiting*
La Jolla, California, 92093-0658
United States
Recruiting Richard Kadota 858-657-7020
Children's Mercy Hospital *Recruiting*
Kansas City, Missouri, 64108
United States
Recruiting Maxine Hetherington 816-234-3265
Robert Wood Johnson Medical School *Recruiting*
New Brunswick, New Jersey, 08901
United States
Recruiting Barton Kamen 732-235-8131
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Beverly Lange 215-590-2249
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Brenda Weigel 612-626-8484
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Arthur Ritchey 412-692-5949
Princess Margaret Hospital for Children *Recruiting*
Perth, Western Australia, 6001
Australia
Recruiting David Baker 61-8-9340-8234
Additional Information:
Study ID Numbers: CDR0000066870; COG-ADVL0018
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003750
Other Childhood Solid Tumor Studies:
1. Treating Inoperable Lung Tumors With Heated Chemotherapy Medicine Delivered Solely to the Lung
2. Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity
3. Stem Cell Transplant for Malignant Melanoma
4. Evaluating The Antitumor Activity Of MEDI-522 With Or Without Dacarbazine In Patients With Metastatic Melanoma
5. IL-2 Gene Therapy for Metastatic Melanoma
Related Studies:
Other childhood solid tumor Clinical Trials
Other California Clinical Trials
Other Duarte Clinical Trials
Biological Therapy in Treating Children With Refractory or Recurrent Neuroblastoma or Other Tumors
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