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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00001573
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institutes of Health Clinical Center (CC)
  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 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study of SU101 in Pediatric Patients With Refractory Malignancy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 30
Study Start Date: March 1997
Estimated Study Completion Date: May 2000
Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001573


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001573     History of Changes
Other Study ID Numbers: 970087
97-C-0087
First Submitted: November 3, 1999
First Posted: December 10, 2002
Last Update Posted: March 4, 2008
Last Verified: February 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
Glioma
PDGF
Pharmacokinetics
Sarcoma
Toxicity

Additional relevant MeSH terms:
Sarcoma
Glioma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Leflunomide
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents