EMD 121974 in Treating Patients With Progressive or Recurrent Glioma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006093
• Other study ID #: CDR0000068098
• Secondary ID: NABTT-9911JHOC-N
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 3, 2000
• Last updated: June 20, 2013
• Start date: September 2000
• Est. completion date: October 2006

Study information

• Verified date: April 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Drug:
• cilengitide

Locations

Country	Name	City	State
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
New Approaches to Brain Tumor Therapy Consortium	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 — View Citation

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.