Cilengitide in Treating Children With Refractory Primary Brain Tumors

Completed · Phase 1

Conditions studied: Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor, Childhood Craniopharyngioma, Childhood Ependymoblastoma, Childhood Grade I Meningioma, Childhood Grade II Meningioma, Childhood Grade III Meningioma, Childhood High-grade Cerebellar Astrocytoma, Childhood High-grade Cerebral Astrocytoma, Childhood Infratentorial Ependymoma, Childhood Low-grade Cerebellar Astrocytoma, Childhood Low-grade Cerebral Astrocytoma, Childhood Medulloepithelioma, Childhood Mixed Glioma, Childhood Oligodendroglioma, Childhood Supratentorial Ependymoma, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Brain Tumor, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Pineoblastoma, Recurrent Childhood Subependymal Giant Cell Astrocytoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway and Hypothalamic Glioma

In brief

This phase I trial is studying the side effects and best dose of cilengitide in treating children with recurrent, progressive, or refractory primary CNS tumors. Cilengitide may slow the growth of brain cancer cells by stopping blood flow to the tumor.

Key facts

Study ID: NCT00063973
Run by: National Cancer Institute (NCI)
People needed: 24
Starts: 2003-07-01
Last updated by the study team: 2013-09-30

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with histological diagnosis of primary CNS tumor and evidence that the tumor is recurrent or progressive and refractory to standard therapy, including histologically benign CNS tumors (e.g. low-grade glioma); clinical and radiographic evidence of a brain stem or optic pathway glioma is required in the absence of histologic diagnosis
Karnofsky or Modified Lansky Score ≥ 50%
Patients with neurological deficits should have deficits that are stable for ≥ 1 week prior to study entry
Chemotherapy: Patients with evidence of recovery from prior therapy; no investigational agent, including biologic agent, within two (2) weeks of study entry; at least six (6) weeks from nitrosourea agent to study entry; at least four (4) weeks from any myelosuppressive therapy to study entry
Bone Marrow Transplant: Greater than six (6) months prior to study entry
XRT: At least six (6) weeks from prior radiation therapy to study entry; greater than three (3) months from prior craniospinal irradiation (> 24 Gy) or total body irradiation to study entry; greater than two (2) weeks from local palliative irradiation to study entry
Anti-convulsants: Patients will be eligible for this study even if they are receiving anti-convulsants
Growth factors: Off all colony forming growth factor(s) > one (1) week prior to study entry (G-CSF, GM-CSF, erythropoietin)
Corticosteroids: Patients receiving corticosteroids must be receiving a stable dose for ≥ one (1) week prior to study entry
ANC > 1,000/μl
Platelets > 100,000/μl (transfusion independent)
Hemoglobin > 8.0 g/dl (may be transfused)
Patients with bone marrow involvement may be eligible
Creatinine < 1.5 times normal range for age
GFR > 70 ml/min/1.73m\^2
Total bilirubin ≤ upper limit of normal for age
SGPT (ALT) and SGOT (AST) < 2.5 times upper limit of normal
Cilengitide was teratogenic when tested in animals; as such, female patients of childbearing potential must have a negative serum or urine pregnancy test prior to study entry; female patients must avoid breast feeding while on study
Patients of childbearing potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study
Signed informed consent according to institutional guidelines must be obtained prior to patient registration

You may not qualify if…

Patient must not be receiving any other anticancer or experimental drug therapy, with the exception of corticosteroids
Patient must have no uncontrolled infection
Patient has no overt renal, hepatic, cardiac or pulmonary disease

Where it is running

Pediatric Brain Tumor Consortium — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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