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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00082758 |
RATIONALE: Biological therapies such as hu14.18-interleukin-2 fusion protein work in different ways to stimulate the immune system and stop tumor cells from growing.
PURPOSE: This phase II trial is studying how well hu14.18-interleukin-2 fusion protein works in treating young patients with recurrent or refractory neuroblastoma.
Condition | Intervention | Phase |
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Neuroblastoma |
Drug: hu14.18-IL2 fusion protein |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of hu14.18-IL2 In Children With Recurrent Or Refractory Neuroblastoma |
Estimated Enrollment: | 60 |
Study Start Date: | August 2005 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to measurable/evaluable disease (measurable by standard radiographic criteria vs evaluable by MIBG scanning and/or bone marrow histology vs disease identified and quantified by bone marrow immunohistochemistry).
Patients receive hu14.18-interleukin-2 fusion protein IV over 4 hours on days 1-3. Treatment repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 40-60 patients (20 for strata 1 and 2 and 0-20 for stratum 3) will be accrued for this study within 2 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable or evaluable disease documented by 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Platelet count ≥ 75,000/mm^3*
Hepatic
Renal
Creatinine adjusted according to age as follows:
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
More than 28 days since prior autologous stem cell transplantation
Chemotherapy
Endocrine therapy
No concurrent corticosteroids except 100 mg or less of hydrocortisone (or equivalent) as premedication for blood transfusion or treatment for transfusion reaction
Radiotherapy
Surgery
Other
Study Chair: | Paul M. Sondel, MD, PhD | University of Wisconsin, Madison |
Investigator: | Suzanne Shusterman, MD | Dana-Farber Cancer Institute |
Study ID Numbers: | CDR0000360723, COG-ANBL0322 |
Study First Received: | May 14, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00082758 |
Health Authority: | United States: Federal Government |
recurrent neuroblastoma |
Neuroectodermal Tumors, Primitive Neuroblastoma Recurrence Antibodies, Monoclonal Neuroectodermal Tumors Antibodies Interleukin-2 |
Neoplasms, Germ Cell and Embryonal Denileukin diftitox Neuroepithelioma Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial Immunoglobulins |
Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Pharmacologic Actions Neoplasms |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Analgesics Peripheral Nervous System Agents Neoplasms, Neuroepithelial Central Nervous System Agents |