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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma  Monoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma
Monoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma
For Condition: regional neuroblastoma,disseminated neuroblastoma,recurrent neuroblastoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Children's Oncology Group
Synopsis: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Combining monoclonal antibody therapy with sargramostim or interleukin-2 may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy given with sargramostim and interleukin-2 in treating children with neuroblastoma who have just completed bone marrow or peripheral stem cell transplantation.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of monoclonal antibody (MOAB) Ch14.18 when combined with sargramostim (GM-CSF) and interleukin-2 (IL-2) after autologous bone marrow or peripheral blood stem cell rescue in children with neuroblastoma. II. Determine the toxic effects of this regimen in these patients. III. Determine the pharmacokinetics, including antibody level, antibody-binding activity, and presence of human anti-chimeric antibodies, of this regimen in these patients. IV. Determine the activity of IL-2 and MOAB Ch14.18 against tumor cells in terms of response using standard clinical measurements such as bone marrow immunocytology in these patients. V. Determine the extent of coating of tumor cells (bone marrow metastases) by MOAB Ch14.18 in these patients. VI. Determine the feasibility of isotretinoin administered between courses beginning after course 2 in these patients. PROTOCOL OUTLINE: This is a multicenter, dose-escalation study of monoclonal antibody (MOAB) Ch14.18. Patients receive MOAB Ch14.18 IV over 5 hours on days 7-10 during courses 2 and 4 and on days 3-6 during courses 1, 3, and 5; sargramostim (GM-CSF) IV over 2 hours or subcutaneously daily on days 0-13 during courses 1, 3, and 5; interleukin-2 IV continuously on days 0-3 and 7-10 during courses 2 and 4; and oral isotretinoin twice daily on days 14-27 during courses 2 and 4 and on days 10-23 during courses 3 and 5. Treatment repeats every 24-32 days for 5 courses in the absence of unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of MOAB Ch14.18 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A minimum of 6 additional patients are treated at the MTD. Patients are followed every other week for 2 months and then every 3 months for 6 months. PROJECTED ACCRUAL: Approximately 6-16 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of neuroblastoma based on tumor histology or bone marrow metastasis with elevated urine catecholamine metabolites; Confirmation of GD2-positivity not required - Must have recently completed a course of myeloablative therapy followed by autologous bone marrow or peripheral blood stem cell (PBSC) rescue - May be eligible: After completion of the third course of high-dose chemotherapy with PBSC rescue on protocol CCG-3951; After completion of 1 or more courses of high-dose chemotherapy with PBSC rescue on an institutional (local) protocol - Previous treatment on phase I studies (e.g., CCG-3951) allowed - Ineligible if evaluable for response on a Phase II/III protocol (e.g., CCG-6921, CCG-3891); Patients who are no longer evaluable for response on a Phase II/III protocol (i.e., disease progression after therapy) are allowed --Prior/Concurrent Therapy-- - Biologic Therapy: See Disease Characteristics; No prior monoclonal antibody (MOAB) 14G2A or MOAB Ch14.18; No other concurrent cytokines or growth factors (e.g., interferon or filgrastim (G-CSF)) - Chemotherapy: See Disease Characteristics; At least 2 weeks since prior myelosuppressive chemotherapy; No other concurrent anticancer chemotherapy - Endocrine therapy: At least 2 weeks since prior corticosteroids; No concurrent corticosteroids - Radiotherapy: At least 7 days since prior radiotherapy; No concurrent radiotherapy except for localized painful lesions - Surgery: Not specified - her: At least 2 weeks since prior immunosuppressive drugs; At least 2 weeks since prior tretinoin; No concurrent immunosuppressive drugs (e.g., cyclosporine); No concurrent pentoxifylline --Patient Characteristics-- - Age: 21 and under - Performance status: 0-2 - Life expectancy: At least 2 months - Hematopoietic: Absolute phagocyte count (neutrophils and monocytes) greater than 1,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times normal; SGOT or SGPT no greater than 5.0 times normal; Concurrent veno-occlusive disease allowed if stable or improving - Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min - Cardiovascular: Shortening fraction at least 27% by echocardiogram OR Ejection fraction greater than 50% by MUGA scan - Pulmonary: FEV1 and FVC greater than 60% predicted OR For children who cannot perform pulmonary function tests: No evidence of dyspnea at rest; No exercise intolerance Oxygen saturation greater than 94% on room air by pulse oximetry - Other: No CNS toxicity greater than grade 1; Concurrent seizure disorder allowed if on anticonvulsants and well controlled
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndrewGilman, Study Chair, Children's Oncology Group
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Cook Children's Medical Center - Fort Worth
Ft. Worth, Texas, 76104
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Boston Floating Hospital Infants and Children
Boston, Massachusetts, 02111
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
City of Hope National Medical Center
Duarte, California, 91010
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Columbia Presbyterian Hospital
New York City, New York, 10032
United States
Royal Children's Hospital
Parkville, Victoria, 3052
Australia
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Texas Children's Cancer Center
Houston, Texas, 77030-2399
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Additional Information:
Study ID Numbers: CDR0000063533; COG-A0935A,CCG-0935,CCG-0935A
Study Start Date: March 2001
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005576
Other Recurrent Neuroblastoma Studies:
1. Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Primitive Neuroectodermal Tumors
2. Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma
3. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
4. Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma
5. Combination Chemotherapy Followed by Surgery in Treating Infants With Newly Diagnosed Neuroblastoma
Related Studies:
Other recurrent neuroblastoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Monoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma
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