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Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy
Not Recruiting
Trial ID: NCT00679354
Purpose
This phase II trial studies how well cilengitide works in treating younger patients with recurrent or progressive high-grade glioma that has not responded to standard therapy. Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.
Official Title
Cilengitide (EMD 121974) (IND# 59073) in Recurrent or Progressive and Refractory Childhood High-Grade Glioma
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
* Histologically confirmed primary central nervous system (CNS) high-grade glioma, including any of the following:
* Glioblastoma multiforme
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* High-grade astrocytoma not otherwise specified (i.e., anaplastic ganglioglioma, anaplastic mixed glioma, or anaplastic mixed glioneuronal tumors)
* No diffuse pontine gliomas, gliomatosis cerebri, and primary spinal cord high-grade astrocytoma
* Gliosarcoma
* Recurrent or progressive disease that is refractory to standard therapy
* Radiographically documented measurable disease
* Lesion must be at least twice the thickness of the image from which it is derived (e.g., 10 mm for a 5 mm slice thickness)
* No diffuse pontine gliomas
* No evidence of prior CNS bleeding
* Karnofsky performance status (PS) 50-100% (patients \> 16 years of age)
* Lansky PS 50-100% (patients =\< 16 years of age)
* Life expectancy \>= 8 weeks
* Absolute neutrophil count (ANC) \>= 1,000/μL
* Platelet count \>= 100,000/μL (transfusion independent)
* Hemoglobin \>= 8.0 g/dL (red blood cell \[RBC\] transfusions allowed)
* Creatinine clearance or radioisotope glomerular filtration rate \>= 70mL/min OR serum creatinine based on age/gender as follows:
* 0.4 mg/dL (1 month to \< 6 months of age)
* 0.5 mg/dL (6 months to \< 1 year of age)
* 0.6 mg/dL (1 to \< 2 years of age)
* 0.8 mg/dL (2 to \< 6 years of age)
* 1.0 mg/dL (6 to \< 10 years of age)
* 1.2 mg/dL (10 to \< 13 years of age)
* 1.5 mg/dL (male) or 1.4mg/dL (female) (13 to \< 16 years of age)
* 1.7 mg/dL (male) or 1.4mg/dL (female) (\>= 16 years of age)
* Total bilirubin =\< 1.5 times upper limit of normal (ULN) for age
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 2.5 times ULN for age
* No evidence of dyspnea at rest
* No exercise intolerance
* Pulse oximetry \> 94%, if determination is clinically indicated
* Seizure disorder is allowed provided it is well-controlled with anticonvulsants
* No uncontrolled infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Recovered from all prior therapy
* No more than two prior treatments for high-grade glioma (i.e., one initial treatment and one treatment for relapse)
* More than 2 weeks since prior myelosuppressive chemotherapy (\>= 6 weeks for nitrosoureas)
* At least 1 week since prior non-myelosuppressive chemotherapy, immunotherapy, or biologic therapy
* At least 2 weeks since prior local palliative radiotherapy (i.e., small port) to a symptomatic non-target lesion only
* At least 3 months since prior craniospinal radiotherapy
* At least 6 weeks since prior substantial bone marrow radiotherapy
* At least 6 months since prior allogeneic stem cell transplant (SCT) or rescue
* Patients who have undergone prior allogeneic SCT and who have graft-versus-host disease (GVHD) must have controlled GVHD that is =\< grade 2
* At least 1 month since prior autologous SCT
* More than 1 week since prior growth factors (\> 3 weeks for pegfilgrastim \[Neulasta®\])
* No other concurrent anticancer therapy, including chemotherapy or immunomodulating agents
* No other concurrent experimental agents or therapies
* No concurrent alternative or complimentary therapies
* No concurrent homeopathic medicines
* No concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid (aspirin)
* No concurrent steroids as anti-emetics
* Concurrent steroids for treatment of increased intracranial pressure allowed if on a stable or decreasing dose for \>= 1 week before study entry
* Concurrent radiotherapy to localized painful lesions allowed provided \>= 1 measurable lesion is not irradiated
Intervention(s):
other: laboratory biomarker analysis
other: pharmacological study
drug: cilengitide
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535