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A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy Clinical research trials and A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy. A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy clinical trial. Test subjects typically receive the most expert healthcare available for their A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy  A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy
A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy
For Condition: Glioma,Sarcoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: A dose escalation scale consisting of 5 dosage levels is being used to determine the maximum tolerated dose (MTD) of SU101. A minimum of 3 and a maximum of 6 patients will be enrolled at each dose level. MTD is defined as the dose level immediately below that at which 2 or more patients exhibit dose limiting toxicity. Each treatment cycle is 21 days. Patients receive a 96 hour continuous IV infusion of SU101 on days 1-4.
Details: SU101 is a member of a novel class of antineoplastic agents, platelet-derived growth factor (PDGF) receptor inhibitors. Preclinical data suggests that SU101 might be an effective agent against neuroglial tumors as well as a variety of sarcomas. A pediatric phase I trial of SU101 in children with these malignancies will be conducted to find the maximum tolerated dose of SU101 and define the toxicity profile of this agent. In addition, we will define the pharmacokinetics of SU101 and its active metabolite SU0020 in pediatric patients and gather preliminary information regarding response.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Histologically proven primary CNS malignancy, neuroblastoma or sarcoma that is refractory to standard therapy or for which no standard therapy exists and disease can not be cured by surgery. PRIOR/CONCURRENT THERAPY: Recovered from toxic affects of all prior therapy. No investigational agent within past 2 weeks. BIOLOGY THERAPY: Not specified. CHEMOTHERAPY: No myelosuppressive therapy within past 3 weeks. No nitrosourea within past 6 weeks. ENDOCRINE THERAPY: If receiving dexamethasone dose must be stable for at least 2 weeks. RADIOTHERAPY: Not specified. SURGERY: Not specified. PATIENT CHARACTERISTICS: Age: 3 to 21. Performance status: ECOG 0-2. Life expectancy: At least 8 weeks. HEMATOPOIETIC: AGC greater than 1500/mm(3). Hemoglobin greater than or equal to 8.0 g/dL percent. Platelet count greater than 100,000/mm(3). For patients with bone marrow involvement or history of bone marrow transplantation or craniospinal radiotherapy: AGC greater than 750/mm(3), Hemoglobin greater than 6.0 g/dL, Platelet count greater than 50,000/mm(3). HEPATIC: SGOT, SGPT or alkaline phosphatase less than 3 times upper limit of normal. Bilirubin no less than or equal to 1.5 times upper limit of normal. RENAL: Ages 3-5 Creatinine no greater than 0.8 mg/dL. Ages 5-10 Creatinine no greater than 1.0 mg/dL. Ages 10-15 Creatinine no greater than 1.2 mg/dL. Ages 16-21 Creatinine no greater than 1.5 mg/dL. OTHER: All patients or their legal guardians (if the patient is under 18 years old) must sign a document of informed consent indicating their understanding of the investigational nature and the risks of this study. For patients with brain tumors who are over 18 years of age, a DPA should be signed. Not pregnant or nursing. Not allergic to etoposide. No acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risks associated with study participation/study drug administration or may interfere with the interpretation of study results.
Total Enrollment: 30
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970087; 97-C-0087
Study Start Date: March 6, 1997
Record last reviewed: February 1, 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001573
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A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy
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