Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy
Condition: Childhood High-grade Cerebellar Astrocytoma; Childhood High-grade Cerebral Astrocytoma; Recurrent Childhood Anaplastic Astrocytoma; Recurrent Childhood Anaplastic Oligoastrocytoma; Recurrent Childhood Anaplastic Oligodendroglioma; Recurrent Childhood Brain Tumor; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Glioblastoma; Recurrent Childhood Visual Pathway and Hypothalamic Glioma
MeSH terms: Glioblastoma; Glioma; Astrocytoma; Oligodendroglioma; Recurrence
Intervention: cilengitide; laboratory biomarker analysis; pharmacological study
Intervention description: Given IV; Correlative studies; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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