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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: | NCT00053326 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well fenretinide works in treating children with recurrent or resistant neuroblastoma.
Condition | Intervention | Phase |
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Neuroblastoma |
Drug: fenretinide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Fenretinide (NSC # 374551, IND #40294) In Children With Recurrent/Resistant High Risk Neuroblastoma |
Study Start Date: | May 2003 |
OBJECTIVES:
OUTLINE: Patients are stratified according to presence of measurable disease on CT scan/MRI (yes vs no). A third stratum of patients with tumor cells in bone marrow by immunocytology only is enrolled but is not evaluated for response.
Patients receive oral fenretinide 3 times daily (or 2 times daily if over 18 years of age) on days 1-7. Treatment repeats every 3 weeks for up to 30 courses in the absence of disease progression or unacceptable toxicity.
Patients in stratum III who fail to acheive a complete response after 8 courses of therapy are removed from study.
Patients are followed monthly until blood counts and visual acuity are stable or normalized and then every 6 months for 2 years and annually for 3 years.
PROJECTED ACCRUAL: A total of 70 patients (25 each for strata I and II, 20 for stratum III) will be accrued for this study within 1-2 years.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of recurrent or resistant/refractory high-risk neuroblastoma by one or both of the following:
Stratum I:
At least 1 unidimensionally measurable lesion*
Stratum II: Meets one or both of the following criteria:
Stratum III:
NOTE: **If lesion was irradiated, biopsy must be performed at least 4 weeks after completion of radiotherapy (for strata I and II)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Judith G. Villablanca, MD | Children's Hospital Los Angeles |
Study ID Numbers: | CDR0000269408, COG-ANBL0321, COG-ADVL0024, COG-A0996 |
Study First Received: | January 27, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00053326 History of Changes |
Health Authority: | United States: Federal Government |
recurrent neuroblastoma |
Anticarcinogenic Agents Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Fenretinide Neuroectodermal Tumors, Primitive, Peripheral Recurrence Neuroblastoma Neoplasms, Glandular and Epithelial |
Anticarcinogenic Agents Neuroectodermal Tumors, Primitive Neoplasms by Histologic Type Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Protective Agents Pharmacologic Actions Neuroblastoma |
Neuroectodermal Tumors Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses Fenretinide Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |