Phase 2
N=112
Cilengitide, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Adult Giant Cell Glioblastoma · Adult Glioblastoma · Adult Gliosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00085254 ↗Enrolled (actual)
112
Serious AEs
0.9%
Results posted
Feb 2016
Primary outcome: Primary: Dose Limiting Toxicities of EMD + RT and TMZ — 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- cilengitide (Drug); temozolomide (Drug); radiation therapy (Radiation); laboratory biomarker analysis (Other); pharmacological study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicities of EMD + RT and TMZ |
0; 0; 0 | — |
| PRIMARY Maximum Tolerated or Tolerable Dose (MTD) - 3 Pre-defined Doses |
NA | — |
| PRIMARY Overall Survival (Phase II) |
19.7 | 0.0001 sig |
| SECONDARY Overall Survival Based on Dose Level - Phase 2 |
17.4; 20.8 | 0.4 |
| SECONDARY Frequency of Hematologic and Nonhematologic Adverse Events |
48; 35 | — |
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 killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving cilengitide together with temozolomide and radiation therapy may kill more tumor cells. This randomized phase I/II trial is studying the side effects and best dose of cilengitide when given together with temozolomide and radiation therapy and to compare how well they work in treating patients with newly diagnosed glioblastoma multiforme
Eligibility Criteria
Inclusion Criteria
- 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 = = 60 mL/min
- Total bilirubin = = 15
- Patients must have tumor tissue form completed and signed by a pathologist
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00085254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.