Recurrent Childhood Ependymoma Clinical Trial
Official title:
A Phase II Study of Sunitinib (NSC# 736511) in Recurrent, Refractory or Progressive High Grade Glioma and Ependymoma Tumors in Pediatric and Young Adult Patients
This phase II trial studies how well sunitinib malate works in treating younger patients with recurrent, refractory, or progressive malignant glioma or ependymoma. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To estimate the objective response rate (partial response [PR] or complete response [CR]
≥ 8 weeks) to sunitinib in 2 strata (recurrent/progressive/refractory high-grade glioma vs
ependymoma) of recurrent or progressive brain tumors in pediatric and young adult patients.
SECONDARY OBJECTIVES:
I. To explore and report descriptively the safety and tolerability of sunitinib in pediatric
and young adult brain tumor patients who have not received prior anthracycline or
radiotherapy involving the heart.
II. To describe the pharmacokinetic profile of pediatric and young adult patients taking
sunitinib malate.
III. To describe the cumulative toxicities of sunitinib when administered over multiple
courses to pediatric and young adult patients.
IV. To estimate progression-free survival (PFS) distributions for these cohorts of patients.
V. To evaluate changes in phosphorylation of PDGFR-α and -β, MEK/ERK, S6 kinase, and AKT in
peripheral blood mononuclear cells and explore possible associations between these changes
and outcome measures.
VI. To evaluate plasma levels of soluble isoforms of VEGFR-1 and -2 prior to initiation of
therapy and at points during therapy as an exploration of possible biomarkers of clinical
response.
VII. To evaluate and report descriptively the expression and ratio of VEGF isoforms in tumor
tissue, as available.
VIII. To evaluate and report descriptively the genotype, expression, and possible
amplification of KIT and PDGFR-α and -β in tumor tissue, as available.
OUTLINE: This is a multicenter study.
Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment
repeats every 42 days for up to 18 courses in the absence of disease progression or
unacceptable toxicity.
Patients may undergo blood sample collection at baseline and during courses 1 and 2 for
pharmacokinetic and pharmacodynamic studies. Tissue samples from diagnosis and surgical
resection may be also collected.
After completion of study treatment, patients are followed up for up to 5 years.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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