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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00001573 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioma Sarcoma |
Drug: SU101 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Phase I Study of SU101 in Pediatric Patients With Refractory Malignancy |
| Estimated Enrollment: | 30 |
| Study Start Date: | March 1997 |
| Estimated Study Completion Date: | May 2000 |
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| ClinicalTrials.gov Identifier: | NCT00001573 History of Changes |
| Other Study ID Numbers: | 970087, 97-C-0087 |
| Study First Received: | November 3, 1999 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United States: Federal Government |
|
Glioma PDGF Pharmacokinetics Sarcoma Toxicity |
|
Glioma Sarcoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Connective and Soft Tissue |
Leflunomide Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Therapeutic Uses |
