EMD 121974 in Treating Patients With Progressive or Recurrent Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006093
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

August 3, 2000
January 27, 2003
June 24, 2013
September 2000
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00006093 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
A Phase I/II Trial of EMD 121974 for Treatment of Patients With Recurrent Anaplastic Gliomas

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.


  • 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.

Phase 1
Phase 2
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
Drug: cilengitide
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
Not Provided
October 2006
Not Provided


  • 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



  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified


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


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


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


  • No advanced coronary artery disease


  • 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


Biologic therapy:

  • No concurrent filgrastim (G-CSF)


  • 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


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


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


  • No other concurrent investigational agents
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Not Provided
New Approaches to Brain Tumor Therapy Consortium
National Cancer Institute (NCI)
Study Chair: Louis B. Nabors, MD University of Alabama at Birmingham
National Cancer Institute (NCI)
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP