EMD 121974 in Treating Patients With Progressive or Recurrent Glioma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006093
First received: August 3, 2000
Last updated: June 20, 2013
Last verified: April 2003

August 3, 2000
June 20, 2013
September 2000
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Complete list of historical versions of study NCT00006093 on ClinicalTrials.gov Archive Site
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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.

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.

Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
Drug: cilengitide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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October 2006
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006093
CDR0000068098, NABTT-9911, JHOC-NABTT-9911
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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