Clinical trial · Interventional
Fenretinide in Treating Children With Solid Tumors
A Phase I Study of Fenretinide (NSC #374551) in Children With High Risk Solid Tumors
NCT00003191CI-TRIAL-00009355completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase I trial to study the effectiveness of fenretinide in treating children who have solid tumors that have not responded to standard therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fenretinide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral fenretinide 3 times a day on days 1-7. Treatment repeats every 3 weeks for up to 8 courses. Patients may receive an additional 22 courses of therapy in the presence of stable or responding residual tumor. Patients with recurrent neuroblastoma, after prior myeloablative therapy with no measurable disease, will stop treatment after 8 courses. Cohorts of 3-6 patients receive escalating doses of fenretinide 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.
- interventionNames
- Drug: fenretinide
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant solid tumor that is refractory to conventional therapy or recurrent neuroblastoma treated with myeloablative therapy and autologous stem cell transplant in second complete or partial response * Bone marrow metastases with granulocytopenia, anemia, and/or thrombocytopenia are eligible PATIENT CHARACTERISTICS: * Age: Under 21 at diagnosis * Performance status: CCG 0-2 * Life expectancy: At least 2 months * Absolute neutrophil count at least 750/mm3 * Platelet count at least 50,000/mm3 * Hemoglobin at least 7.0 g/dL * Bilirubin no greater than 1.5 mg/dL * SGOT and SGPT less than 2.5 times normal * Creatinine no greater than 1.5 g/dL OR creatinine clearance at least 50 mL/min OR radioisotope GFR at least 50 mL/min * Seizure disorders controlled with anticonvulsants allowed * No CNS toxicity greater than grade 2 * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * At least 1 month since prior autologous stem cell transplantation * No prior allogeneic transplantation * At least 2 weeks since prior chemotherapy (4 weeks for nitrosourea) and recovered * No other concurrent chemotherapy * No concurrent immunomodulating agents (including steroids) * Concurrent corticosteroid therapy for increased intracranial pressure allowed * Concurrent dexamethasone for CNS tumor allowed * At least 2 weeks since prior radiotherapy * Concurrent radiotherapy to localized lesions allowed * At least 2 weeks since prior retinoids Prior isotretinoin or 9-cis-retinoic acid allowed
References
Publications (2)
- RESULTChildren's Oncology Group (CCG 09709); Villablanca JG, Krailo MD, Ames MM, Reid JM, Reaman GH, Reynolds CP. Phase I trial of oral fenretinide in children with high-risk solid tumors: a report from the Children's Oncology Group (CCG 09709). J Clin Oncol. 2006 Jul 20;24(21):3423-30. doi: 10.1200/JCO.2005.03.9271. PMID 16849757
- RESULTVillablanca JG, Ames MW, Reid JM, et al.: Phase I trial of oral [N-(-4-hydroxyphenyl)retinamide] (4-HPR) in children with resistant/recurrent solid tumors: a children's cancer group study (CCG 09709). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1588, 2002.