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Sponsors and Collaborators: |
New Approaches to Neuroblastoma Therapy Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005978 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy.
PURPOSE: This phase I trial is studying the side effects and best dose of combination chemotherapy when given before stem cell transplant and radiation therapy in treating patients with neuroblastoma that has not responded to previous treatments.
Condition | Intervention | Phase |
---|---|---|
Neuroblastoma |
Biological: filgrastim Drug: carboplatin Drug: etoposide Drug: melphalan Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: iodine I 131 metaiodobenzylguanidine Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Dose Escalation Study of 131 I-Metaiodobenzylguanidine (MIBG) With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma - A Phase I Study |
Study Start Date: | May 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of iodine I 131 metaiodobenzylguanidine (131 I-MIBG), carboplatin, and etoposide. Patients are stratified according to glomerular filtration rate (at least 100 mL/min vs 60-99 mL/min).
Patients undergo peripheral blood stem cell harvest or bone marrow harvest at least 2 weeks prior to treatment with 131 I-MIBG.
Patients receive 131 I-MIBG IV over 120 minutes on day -21; melphalan IV on days -7 to -5; carboplatin and etoposide IV continuously over 96 hours on days -7 to -4; autologous hematopoietic stem cell transplantation IV over 15-30 minutes on day 0; and filgrastim (G-CSF) subcutaneously or IV starting on day 0 and continuing until blood counts recover. Radiotherapy is administered to the primary tumor site and metastatic sites twice daily for 7 consecutive days within 6 weeks of transplantation or once blood counts have recovered.
Cohorts of 3-6 patients receive escalating doses of 131 I-MIBG, carboplatin, and etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at day 84, and then 2 months later if there is a complete response and/or partial response. Patients who continue therapy on other protocols are followed before starting the new therapy. All patients are followed for life for any delayed toxic effects related to study therapy, secondary malignancies, disease status, and survival.
PROJECTED ACCRUAL: A total of 30-60 patients (15-30 per stratum) will be accrued for this study within 2-3 years.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of neuroblastoma as evidenced by one of the following:
Poorly responding disease, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
No prior myeloablative therapy
United States, California | |
Children's Hospital Los Angeles | |
Los Angeles, California, United States, 90027-0700 | |
Lucile Packard Children's Hospital at Stanford University Medical Center | |
Palo Alto, California, United States, 94304 | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94143 | |
United States, Georgia | |
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
Children's Memorial Hospital - Chicago | |
Chicago, Illinois, United States, 60614 | |
United States, Indiana | |
Indiana University Cancer Center | |
Indianapolis, Indiana, United States, 46202-5289 | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 | |
United States, Massachusetts | |
Children's Hospital Boston | |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109-0914 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229-3039 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Texas Children's Cancer Center | |
Houston, Texas, United States, 77030-2399 | |
United States, Washington | |
Children's Hospital and Regional Medical Center - Seattle | |
Seattle, Washington, United States, 98105 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Study Chair: | Katherine K. Matthay, MD | Children's Hospital Los Angeles |
Study ID Numbers: | CDR0000067966, NANT-99-01, CHLA-LA-NANT-99-01, NCI-V00-1592 |
Study First Received: | July 5, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005978 History of Changes |
Health Authority: | United States: Federal Government |
localized resectable neuroblastoma regional neuroblastoma disseminated neuroblastoma |
stage 4S neuroblastoma recurrent neuroblastoma localized unresectable neuroblastoma |
Melphalan Neuroectodermal Tumors, Primitive Carboplatin Etoposide phosphate Neuroblastoma Recurrence Neuroectodermal Tumors |
3-Iodobenzylguanidine Neoplasms, Germ Cell and Embryonal Neuroepithelioma Iodine Etoposide Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Enzyme Inhibitors Carboplatin Pharmacologic Actions Neuroblastoma |
Neuroectodermal Tumors Neoplasms 3-Iodobenzylguanidine Therapeutic Uses Neoplasms, Germ Cell and Embryonal Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |