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Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), January 2009
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00679354
  Purpose

RATIONALE: Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well cilengitide works in treating younger patients with recurrent or progressive high-grade glioma that has not responded to standard therapy.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: cilengitide
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: Cilengitide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Cilengitide (EMD 121974) (IND# 59073) in Recurrent or Progressive and Refractory Childhood High-Grade Glioma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to tumor progression [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Time to death [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: June 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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

  • To estimate the distribution of time to progression, time to treatment failure, and time to death in these patients.
  • To estimate the rate of toxicity, especially symptomatic intratumoral hemorrhage, in these patients.

OUTLINE: This is a multicenter study.

Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 2 years and then periodically for 3 years.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed* primary 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)
    • Gliosarcoma NOTE: *Histopathologic diagnosis at the time of initial presentation or recurrence is required
  • 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

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) 50-100% (patients > 16 years of age)
  • Lansky PS 50-100% (patients ≤ 16 years of age)
  • Life expectancy ≥ 8 weeks
  • ANC ≥ 1,000/μL
  • Platelet count ≥ 100,000/μL (transfusion independent)
  • Hemoglobin ≥ 8.0 g/dL (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 1.4 mg/dL (female) (13 to < 16 years of age)
    • 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
  • ALT and 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

PRIOR CONCURRENT THERAPY:

  • 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 transplantation (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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00679354

  Show 53 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Tobey MacDonald, MD Childrens Research Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000595623, COG-ACNS0621
Study First Received: May 14, 2008
Last Updated: January 2, 2009
ClinicalTrials.gov Identifier: NCT00679354  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent childhood brain stem glioma
childhood high-grade cerebellar astrocytoma
childhood high-grade cerebral astrocytoma
recurrent childhood cerebral astrocytoma
recurrent childhood cerebellar astrocytoma
childhood oligodendroglioma
recurrent childhood visual pathway and hypothalamic glioma
recurrent childhood brain tumor

Study placed in the following topic categories:
Neuroectodermal Tumors
Brain Neoplasms
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioma
Central Nervous System Neoplasms
Recurrence
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on January 15, 2009