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Status:

COMPLETED

Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Childhood High-grade Cerebellar Astrocytoma

Childhood High-grade Cerebral Astrocytoma

Eligibility:

All Genders

Up to 21 years

Phase:

PHASE2

Brief 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...

Detailed Description

PRIMARY OBJECTIVES: I. To determine the objective response rate to cilengitide in younger patients with recurrent or progressive high-grade glioma that is refractory to standard therapy. SECONDARY O...

Eligibility Criteria

Inclusion

  • 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:
  • 4 mg/dL (1 month to \< 6 months of age)
  • 5 mg/dL (6 months to \< 1 year of age)
  • 6 mg/dL (1 to \< 2 years of age)
  • 8 mg/dL (2 to \< 6 years of age)
  • 0 mg/dL (6 to \< 10 years of age)
  • 2 mg/dL (10 to \< 13 years of age)
  • 5 mg/dL (male) or 1.4mg/dL (female) (13 to \< 16 years of age)
  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2011

    Estimated Enrollment :

    30 Patients enrolled

    Trial Details

    Trial ID

    NCT00679354

    Start Date

    June 1 2008

    End Date

    July 1 2011

    Last Update

    August 1 2018

    Active Locations (20)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 5 (20 locations)

    1

    Kaiser Permanente-Oakland

    Oakland, California, United States, 94611

    2

    University of California San Francisco Medical Center-Parnassus

    San Francisco, California, United States, 94143

    3

    Lombardi Comprehensive Cancer Center at Georgetown University

    Washington D.C., District of Columbia, United States, 20057

    4

    Lurie Children's Hospital-Chicago

    Chicago, Illinois, United States, 60614