|
Fenretinide in Treating Children With Solid Tumors Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Fenretinide in Treating Children With Solid Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Fenretinide in Treating Children With Solid Tumors Clinical research trials and Fenretinide in Treating Children With Solid Tumors healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Fenretinide in Treating Children With Solid Tumors. Fenretinide in Treating Children With Solid Tumors Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Fenretinide in Treating Children With Solid Tumors clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Fenretinide in Treating Children With Solid Tumors condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "F" Clinical Trials Conditions > Fenretinide in Treating Children With Solid Tumors  Fenretinide in Treating Children With Solid Tumors
Fenretinide in Treating Children With Solid Tumors
For Condition: unspecified childhood solid tumor, protocol specific,recurrent neuroblastoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Children's Cancer Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of fenretinide in treating children who have solid tumors that have not responded to standard therapy.
Details: 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. PROTOCOL 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. PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study in 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --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 --Prior/Concurrent Therapy-- - Biologic therapy: At least 1 month since prior autologous stem cell transplantation; No prior allogeneic transplantation - Chemotherapy: At least 2 weeks since prior chemotherapy (4 weeks for nitrosourea) and recovered; No other concurrent chemotherapy - Endocrine therapy: No concurrent immunomodulating agents (including steroids); Concurrent corticosteroid therapy for increased intracranial pressure allowed; Concurrent dexamethasone for CNS tumor allowed - Radiotherapy: At least 2 weeks since prior radiotherapy; Concurrent radiotherapy to localized lesions allowed - Surgery: Not specified - Other: At least 2 weeks since prior retinoids; Prior isotretinoin or 9-cis-retinoic acid allowed --Patient Characteristics-- - Age: Under 21 at diagnosis - Performance status: CCG 0-2 - Life expectancy: At least 2 months - Hematopoietic: Absolute neutrophil count at least 750/mm3; Platelet count at least 50,000/mm3; Hemoglobin at least 7.0 g/dL - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT and SGPT less than 2.5 times normal - Renal: Creatinine no greater than 1.5 g/dL OR Creatinine clearance at least 50 mL/min OR Radioisotope GFR at least 50 mL/min - Other: Seizure disorders controlled with anticonvulsants allowed; No CNS toxicity greater than grade 2; Not pregnant; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JudithVillablanca, Study Chair, Children's Cancer Group
Children's Hospital of Orange County
Orange, California, 92868
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Long Beach Memorial Medical Center
Long Beach, California, 90806
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: CDR0000066023; CCG-09709
Study Start Date: July 1999
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003191
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma
2. Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
3. Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
4. Gene Therapy in Treating Children With Refractory or Recurrent Neuroblastoma
5. Induction Chemotherapy Using Cyclophosphamide and Topotecan in Treating Patients Who Are Undergoing Autologous Peripheral Stem Cell Transplantation for Newly Diagnosed or Progressive Neuroblastoma
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other Missouri Clinical Trials
Other Kansas City Clinical Trials
Fenretinide in Treating Children With Solid Tumors
|
|
|
|
|
|
|
|
