Cilengitide in Treating Children With Refractory Primary Brain Tumors

NCT00063973 | Completed Phase 1

• 4 other identifiers: NCI-2012-03175CDR653715PBTC-012U01CA081457
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• MTD of cilengitide

  4 weeks

Secondary Outcomes (1)

• Response

  Up to 3 months

Study Arms (1)

Treatment (cilengitide)

EXPERIMENTAL

Patients receive cilengitide (EMD 121974) IV over 1 hour twice weekly. Treatment repeats every 4 weeks for 13 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cilengitide until the MTD is determined. The MTD is defined as the dose at which 25% of patients are expected to experience dose-limiting toxicity. Once the MTD is determined, 6 additional patients are accrued and treated at that dose level for a total of 12 patients at the MTD.

Drug: cilengitide; Other: laboratory biomarker analysis

Interventions

cilengitide DRUG

Given IV

Also known as: EMD 121974

Treatment (cilengitide)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (cilengitide)

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Pediatric Brain Tumor Consortium

Memphis, Tennessee, 38105, United States

Location

MeSH Terms

Conditions

Choroid Plexus Neoplasms; Astrocytoma; Oligodendroglioma; Familial ependymoma; Medulloblastoma; Optic Nerve Glioma

Interventions

Cilengitide

Condition Hierarchy (Ancestors)

Cerebral Ventricle Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Eye Diseases

Study Officials

• Tobey MacDonald

  Pediatric Brain Tumor Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2003
• First Posted: July 9, 2003
• Study Start: July 1, 2003
• Primary Completion: March 1, 2008
• Last Updated: September 30, 2013

Record last verified: 2013-09

Locations

US (1)