Status:
COMPLETED
Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Cilengitide may stop the growth of cancer by stopping blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by kil...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the safety profile of EMD 121974 (cilengitide) when administered as a one-hour infusion twice a week concurrently with concomitant and adjuvant temozolomide with radi...
Eligibility Criteria
Inclusion
- Patients must have histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme)
- Patients must not have received prior radiation therapy, chemotherapy, immunotherapy or therapy with biologic agent (including immunotoxins, immunoconjugates, antisense, peptide receptor antagonists, interferons, interleukins, TIL, LAK or gene therapy), or hormonal therapy for their brain tumor; glucocorticoid therapy is allowed
- Patients must have a Karnofsky performance status \>= 60% (i.e. the patient must be able to care for himself/herself with occasional help from others)
- Absolute neutrophil count \>= 1500/mm\^3
- Platelets \>= 100,000/mm\^3
- Creatinine =\< 1.5 mg/dl or creatinine clearance \>= 60 mL/min
- Total bilirubin =\< 1.5 mg/dl
- Transaminases =\< 4 times above the upper limits of the institutional normal
- Patients must be able to provide written informed consent
- Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (no increase for 5 days) prior to the start of treatment
- Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception; women of childbearing potential must have a negative pregnancy test
- Patients must have a Mini Mental State Exam score of \>= 15
- Patients must have tumor tissue form completed and signed by a pathologist
Exclusion
- Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety
- Patients who are pregnant or breast-feeding
- Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents)
- Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin; patients who have been free of disease (any prior malignancy) for \>= five years are eligible for this study
- Patients who are unable to undergo an MRI evaluation
- Patients with a history of wound-healing disorders, advanced coronary disease, or with a recent history (# 1 year) of peptic ulcer disease are ineligible
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00085254
Start Date
April 1 2005
End Date
November 1 2012
Last Update
February 25 2016
Active Locations (8)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Emory University
Atlanta, Georgia, United States, 30322
3
Johns Hopkins University
Baltimore, Maryland, United States, 21287
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114