Search / Trial NCT00001573

A Phase I Study of SU101 in Pediatric Patients With Refractory Malignancy

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of March 02, 2024

Completed

Keywords

Glioma Pdgf Pharmacokinetics Sarcoma Toxicity

Description

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.

Gender

All

Eligibility 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.

Attachments

readout_NCT00001573_2024-03-02.pdf

4.5 MB

NCT00001573_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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