Platelet-derived growth factor in human glioma.
B Westermark, C H Heldin, M Nistér
https://pubmed.ncbi.nlm.nih.gov/8586462Completed
Phase 1
All Genders
ID00001573
A Phase I Study of SU101 in Pediatric Patients With Refractory Malignancy
Led by National Cancer Institute (NCI) · Updated on 2008-03-04
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I Study of SU101 in Pediatric Patients With Refractory Malignancy
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Coexpression of platelet-derived growth factor (PDGF) and PDGF-receptor genes by primary human astrocytomas may contribute to their development and maintenance.
M Maxwell, S P Naber, H J Wolfe...
https://pubmed.ncbi.nlm.nih.gov/2164040Human neuroblastoma cells express alpha and beta platelet-derived growth factor receptors coupling with neurotrophic and chemotactic signaling.
T Matsui, K Sano, T Tsukamoto...
https://pubmed.ncbi.nlm.nih.gov/8376577