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CompletedNCT00006093Updated Jun 24, 2013

EMD 121974 in Treating Patients With Progressive or Recurrent Glioma

A Phase 1/2 interventional study of cilengitide in Brain and Central Nervous System Tumors, sponsored by New Approaches to Brain Tumor Therapy Consortium. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-06-24.

Sponsored by New Approaches to Brain Tumor Therapy Consortium · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Ages
18 Years and older
Sex
All
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Study summary

RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: Phase I/II trial to study the effectiveness of EMD 121974 in treating patients who have progressive or recurrent malignant glioma.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose and dose-limiting toxicity of EMD 121974 in patients with progressive or recurrent malignant glioma.
  • Determine the 6-month progression-free survival, clinical response rate, duration of progression-free survival, and overall survival in patients treated with this drug.
  • Determine the effects of this drug on tumor perfusion, measured with magnetic resonance perfusion scan, and markers for angiogenesis in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 6-12 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 2 of 6 or 4 of 12 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at the MTD.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A minimum of 6 patients will be accrued for phase I of this study within 2-3 months. A total of 23-38 patients will be accrued for phase II of this study within 5-10 months.

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Conditions studied

  • Brain and Central Nervous System Tumors

Keywords

  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
03

In context

Nervous System Neoplasms

538 studies on the registry are indexed under Nervous System Neoplasms; 14 are open to participants now.

Browse Nervous System Neoplasms studies →

Lead sponsor

New Approaches to Brain Tumor Therapy Consortium is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant glioma that is progressive or recurrent after radiotherapy and/or chemotherapy

    • Eligible subtypes:

      • Anaplastic astrocytoma
      • Anaplastic oligodendroglioma
      • Glioblastoma multiforme
    • Prior low-grade glioma that has progressed to a high-grade glioma (by biopsy) after radiotherapy and/or chemotherapy allowed
  • Measurable disease by volumetric and magnetic resonance perfusion scan
  • Prior biopsy or resection of recurrent brain tumor allowed

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3

Hepatic:

  • Bilirubin normal
  • Transaminases no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No advanced coronary artery disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No serious concurrent infection or medical illness that would preclude study
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
  • No history of wound healing disorders
  • No peptic ulcer disease within the past year
  • Mini mental score of at least 15
  • Willing and able to undergo MRI

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent filgrastim (G-CSF)

Chemotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
  • No more than 2 prior chemotherapy regimens

Endocrine therapy:

  • Prior corticosteroids allowed if on stable dose for at least 5 days prior to study
  • Concurrent corticosteroids (e.g., dexamethasone) allowed as clinically needed

Radiotherapy:

  • See Disease Characteristics
  • At least 3 months since prior radiotherapy and recovered

Surgery:

  • See Disease Characteristics
  • At least 1 week since prior surgery and recovered
  • No concurrent elective surgery or dental extractions

Other:

  • No other concurrent investigational agents
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment

Interventions

  • Drugcilengitide
06

Study locations

10 sites
  • University of Alabama at Birmingham Comprehensive Cancer Center
    Birmingham, Alabama 35294-3300, United States
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612-9497, United States
  • Emory University Hospital - Atlanta
    Atlanta, Georgia 30322, United States
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Baltimore, Maryland 21231-2410, United States
  • Massachusetts General Hospital Cancer Center
    Boston, Massachusetts 02114, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Comprehensive Cancer Center at Wake Forest University
    Winston-Salem, North Carolina 27157-1082, United States
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio 44195, United States
  • University of Pennsylvania Cancer Center
    Philadelphia, Pennsylvania 19104-4283, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78284-7811, United States
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References and documents

Publications

  • Nabors LB, Mikkelsen T, Rosenfeld SS, Hochberg F, Akella NS, Fisher JD, Cloud GA, Zhang Y, Carson K, Wittemer SM, Colevas AD, Grossman SA. Phase I and correlative biology study of cilengitide in patients with recurrent malignant glioma. J Clin Oncol. 2007 May 1;25(13):1651-7. doi: 10.1200/JCO.2006.06.6514. PubMed 17470857 ↗
  • Nabors LB, Rosenfeld SS, Mikkelsen T, et al.: NABTT 9911: a phase I trial of EMD 121974 for treatment of patients with recurrent malignant gliomas. [Abstract] Neuro-Oncology 6 (4): TA-39, 379, 2004.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00006093
Lead sponsor
New Approaches to Brain Tumor Therapy Consortium
Collaborators
National Cancer Institute (NCI)
First posted
Jan 27, 2003
Start date
Sep 2000
Completion
Oct 2006
Last update
Jun 24, 2013

Study contacts

Louis B. Nabors, MD
study chair · University of Alabama at Birmingham
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2003. You cannot join it, but the record below documents what was studied.

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