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