EMD 121974 in Treating Patients With Progressive or Recurrent Glioma

Sponsor

New Approaches to Brain Tumor Therapy Consortium (Other)

Overall Status

Completed

CT.gov ID

NCT00006093

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: cilengitide	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2000

Actual Study Completion Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama	United States	35294-3300
2	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612-9497
3	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
4	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
5	Massachusetts General Hospital Cancer Center	Boston	Massachusetts	United States	02114
6	Henry Ford Hospital	Detroit	Michigan	United States	48202
7	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina	United States	27157-1082
8	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
9	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania	United States	19104-4283
10	University of Texas Health Science Center at San Antonio	San Antonio	Texas	United States	78284-7811