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A Phase I/II Trial of EMD 121974 for Treatment of Patients With Recurrent Anaplastic Gliomas

Phase 1/Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Phase I/II Trial of EMD 121974 for Treatment of Patients With Recurrent Anaplastic Gliomas


- 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

Inclusion Criteria


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Louis B. Nabors, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham


United States: Federal Government

Study ID:




Start Date:

September 2000

Completion Date:

October 2006

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



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