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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 21 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00679354
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tobey MacDonald
Principal Investigator Affiliation Children's Oncology Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

NIH
Overall Status Completed
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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
Additional Details

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 OBJECTIVES:
  • I. To estimate the distribution of time to progression, time to treatment failure, and time to death in these patients.
  • II. To estimate the rate of toxicity, especially symptomatic intratumoral hemorrhage, in these patients.
  • III. To evaluate the pharmacokinetics of cilengitide in plasma using a limited sampling strategy.
  • IV. To evaluate the pharmacogenetic polymorphisms in drug transporters (eg, breast cancer resistance protein [BCRP], P-glycoprotein [P-gp]) and relate to cilengitide disposition.
OUTLINE: 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 treatment, patients are followed up every 3 months for 2 years and then periodically for 3 years.

Arms & Interventions

Arms

Experimental: Treatment (cilengitide)

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.

Interventions

Drug: - cilengitide

Given IV

Other: - laboratory biomarker analysis

Correlative studies

Other: - pharmacological study

Correlative studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Kaiser Permanente-Oakland, Oakland, California

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Address

Kaiser Permanente-Oakland

Oakland, California, 94611

San Francisco, California

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Address

University of California San Francisco Medical Center-Parnassus

San Francisco, California, 94143

Washington, District of Columbia

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Lombardi Comprehensive Cancer Center at Georgetown University

Washington, District of Columbia, 20057

Lurie Children's Hospital-Chicago, Chicago, Illinois

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Lurie Children's Hospital-Chicago

Chicago, Illinois, 60614

Boston, Massachusetts

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Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Detroit, Michigan

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Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201

Newark Beth Israel Medical Center, Newark, New Jersey

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Address

Newark Beth Israel Medical Center

Newark, New Jersey, 07112

Montefiore Medical Center, Bronx, New York

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Montefiore Medical Center

Bronx, New York, 10467-2490

New York, New York

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Address

New York University Langone Medical Center

New York, New York, 10016

Wake Forest University Health Sciences, Winston-Salem, North Carolina

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Address

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Akron, Ohio

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Address

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308

Nationwide Children's Hospital, Columbus, Ohio

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Address

Nationwide Children's Hospital

Columbus, Ohio, 43205

Oregon Health and Science University, Portland, Oregon

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Address

Oregon Health and Science University

Portland, Oregon, 97239

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

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Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

Palmetto Health Richland, Columbia, South Carolina

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Address

Palmetto Health Richland

Columbia, South Carolina, 29203

T C Thompson Children's Hospital, Chattanooga, Tennessee

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Address

T C Thompson Children's Hospital

Chattanooga, Tennessee, 37403

St. Jude Children's Research Hospital, Memphis, Tennessee

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Address

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

Seattle Children's Hospital, Seattle, Washington

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Address

Seattle Children's Hospital

Seattle, Washington, 98105

Midwest Children's Cancer Center, Milwaukee, Wisconsin

Status

Address

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226

International Sites

CancerCare Manitoba, Winnipeg, Manitoba, Canada

Status

Address

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9