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Cilengitide (EMD 121974) for Recurrent Glioblastoma Multiforme (Brain Tumor)

Study Purpose

This study will investigate clinical activity, safety, and tolerability of the anti-angiogenic compound cilengitide (EMD 121974) in the treatment of first recurrence of glioblastoma multiforme (GBM).

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 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Written informed consent obtained before undergoing any study-related activities.
  • - Males or females 18 years of age or older who can be treated in an outpatient setting.
  • - Histologically proven GBM, which is recurrent or progressive following surgery or biopsy, external beam radiation therapy, and 1 previous regimen of systemic chemotherapy (Gliadel wafer therapy is not considered systemic chemotherapy).
Malignancy is to be documented with a previous histopathological report.
  • - Subjects initially diagnosed with other conditions similar to GBM (such as anaplastic astrocytoma [AA] or low grade glioma) that subsequently progressed to histologically proven GBM and have had surgery or biopsy, external beam radiation therapy, and 1 previous regimen of systemic chemotherapy for the original diagnosis are eligible if they meet all inclusion criteria.
  • - GBM recurring only in the contralateral hemisphere must be histologically confirmed by biopsy.
GBM recurring bilaterally does not need to be histologically confirmed by biopsy (i.e., if recurrence is ipsilateral and contralateral).
  • - Archived tumor tissue specimens from the GBM surgery or biopsy must be available for central pathology review and exploratory analysis of angiogenic markers (e.g. αvβ3 and αvβ5 integrins).
  • - Measurable disease (solid contrast-enhancing lesion greater than or equal to (>=)1 cm in any dimension) evaluated by gadolinium-enhanced magnetic resonance imaging (Gd MRI) within 2 weeks prior to the first dose of EMD 121974.
  • - At least 12 weeks have elapsed since the last radiation treatment, and at least 4 weeks have elapsed since the last chemotherapy dose (at least 6 weeks for nitrosourea-containing chemotherapy) prior to the first dose of EMD 121974.
  • - If the subject underwent recent surgery, status must be >=2 weeks post surgery or >=1 week post biopsy, in stable condition, and maintained on a stable corticosteroid regimen for >=5 days prior to first dose of EMD 121974.
  • - Karnofsky Performance Score (KPS) of >=70%.
  • - Subjects with the potential for pregnancy or impregnating their partner must agree to follow acceptable methods of birth control to avoid conception during the study and for at least 6 months after receiving the last dose of study drug.
  • - Women of childbearing potential must have a negative pregnancy test at screening.
  • - Laboratory values (within 1 week prior to the first dose of EMD 121974, except for blood count and Prothrombin time (PT)/Partial thromboplastin time (PTT), which are to be within 72 hours of the first dose): Absolute neutrophil count >=1500/millimeter (mm)^3.
Platelets >=100,000/mm^3. Creatinine less than or equal to (<=) 1.5 milligram/deciliter (mg/dL) or creatinine clearance >=60 mL/min. Hematocrit >=30%. Prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits. Hemoglobin >=10 mg/dL. Total bilirubin <=1.5 times the upper limit of normal. Aspartate aminotransferase and alanine aminotransferase <=2.5 times above upper limit of normal.
  • - No more than 8 weeks have elapsed since recurrence was detected.

Exclusion Criteria:

  • - Prior radiation therapy greater than (>) 66 Gray.
  • - Subject anticipates undergoing elective surgery, dental extraction, or invasive dental procedures.
  • - History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months of enrollment.
  • - History of prior malignancy.
Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for ≥5 years are eligible for this study.
  • - History of coagulation disorder associated with bleeding or recurrent thrombotic events.
  • - Concurrent illness, including severe infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety.
  • - Subject is pregnant, anticipates becoming pregnant within 6 months after study participation, or is currently breast-feeding.
  • - Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of EMD 121974.
  • - Prior antiangiogenic therapy.
  • - Placement of Gliadel wafer at surgery for recurrence.
  • - Unable to undergo Gd MRI.
  • - Current known alcohol dependence or drug abuse.
  • - Requiring concomitant chemotherapy.
  • - Treatment with a prohibited concomitant medication.
  • - Known hypersensitivity to the study treatment.
  • - Legal incapacity or limited legal capacity.

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.

NCT00093964
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.

EMD Serono
Principal Investigator

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

Medical Responsible
Principal Investigator Affiliation EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany
Agency Class

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

Industry
Overall Status Completed
Countries United States
Conditions

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

Glioblastoma Multiforme
Arms & Interventions

Arms

Experimental: Cilengitide 500 Milligram (mg)

Experimental: Cilengitide 2000 mg

Interventions

Drug: - Cilengitide 500 mg

Subjects will receive 1-hour intravenous infusion of 500 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

Drug: - Cilengitide 2000 mg

Subjects will receive 1-hour intravenous infusion of 2000 mg cilengitide twice weekly on Day 1 and 4 of each week during every 4-week cycle, for a total of 8 infusions per cycle. Cycles were repeated without pause until progressive disease (PD), unacceptable adverse events (AEs), or withdrawal of consent.

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.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3280

Barrow Neurological Institute, Phoenix, Arizona

Status

Address

Barrow Neurological Institute

Phoenix, Arizona, 85013

UCLA Medical Center, Los Angeles, California

Status

Address

UCLA Medical Center

Los Angeles, California, 90095

Denise Damek, Aurora, Colorado

Status

Address

Denise Damek

Aurora, Colorado, 80010

Northwestern University, Chicago, Illinois

Status

Address

Northwestern University

Chicago, Illinois, 60611

Indiana University Medical Center, Indianapolis, Indiana

Status

Address

Indiana University Medical Center

Indianapolis, Indiana, 46202

Massachusetts General Hospital, Boston, Massachusetts

Status

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

University of Massachusetts, Worcester, Massachusetts

Status

Address

University of Massachusetts

Worcester, Massachusetts, 01655

Henry Ford Health System, Detroit, Michigan

Status

Address

Henry Ford Health System

Detroit, Michigan, 48202

Washington University, Saint Louis, Missouri

Status

Address

Washington University

Saint Louis, Missouri, 63110

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10021

Duke University Medical Center, Durham, North Carolina

Status

Address

Duke University Medical Center

Durham, North Carolina, 27710

Cincinnati, Ohio

Status

Address

Good Samaritan Hospital/Tri Health Hatton Center

Cincinnati, Ohio, 45206

Dallas, Texas

Status

Address

Baylor University Medical Center at Dallas

Dallas, Texas, 75246

Houston, Texas

Status

Address

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

Burlington, Vermont

Status

Address

University of Vermont/Fletcher Allen Healthcare

Burlington, Vermont, 05401

University of Virginia Health System, Charlottesville, Virginia

Status

Address

University of Virginia Health System

Charlottesville, Virginia, 22903