Fenretinide in Treating Children With Solid Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neuroblastoma Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: fenretinide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Fenretinide (NSC #374551) in Children With High Risk Solid Tumors |
| Enrollment: | 18 |
| Study Start Date: | March 1998 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
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.
|
Drug: fenretinide |
Detailed Description:
OBJECTIVES:
I. Determine the maximum tolerated dose of fenretinide (HPR) in children with high risk solid tumors.
II. Determine the toxicities of HPR in these patients. III. Determine the pharmacokinetics of HPR in these patients. IV. Determine the CSF level of HPR in patients whom cerebrospinal fluid is obtained for routine purposes while on this study.
V. Determine the effect of HPR on plasma retinol levels in these patients. VI. Determine the activity of HPR in these patients. VII. Determine the antitumor activity of HPR on minimal residual bone marrow disease in neuroblastoma.
OUTLINE: This is a dose escalation study.
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.
Patients are followed until death.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 26 Study Locations| Study Chair: | Judith G. Villablanca, MD | Children's Hospital Los Angeles |
More Information
Additional Information:
Publications:
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003191 History of Changes |
| Other Study ID Numbers: | NCI-2012-02262, CCG-09709, CDR0000066023 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Cancer Institute (NCI):
|
recurrent neuroblastoma unspecified childhood solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neuroblastoma Neoplasms Neuroectodermal Tumors, Primitive, Peripheral Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Fenretinide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013