Overview

Cilengitide in Treating Children With Refractory Primary Brain Tumors

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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