Trials / Completed
CompletedNCT00369590
VEGF Trap in Treating Patients With Recurrent Malignant Gliomas That Did Not Respond to Temozolomide
Phase II Single Arm Trial of VEGF Trap in Patients With Recurrent Temozolomide-Resistant Malignant Gliomas
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 58 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial is studying how well VEGF Trap works in treating patients with recurrent malignant or anaplastic gliomas that did not respond to temozolomide. VEGF Trap may stop the growth of malignant or anaplastic gliomas by blocking blood flow to the tumor.
Detailed description
PRIMARY OBJECTIVES: I. Determine the therapeutic efficacy of VEGF Trap in patients with temozolomide-resistant malignant gliomas at first recurrence as measured by 6-month progression-free survival (PFS). II. Determine the safety profile of VEGF Trap in these patients. SECONDARY OBJECTIVES: I. Determine the efficacy of this regimen as measured by radiographic response, PFS, time to progression, and overall survival. II. Characterize the single-dose and repeated-dose pharmacokinetic profiles of VEGF Trap in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to histology (glioblastoma vs anaplastic glioma). Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.
Conditions
- Adult Anaplastic Astrocytoma
- Adult Anaplastic Oligodendroglioma
- Adult Giant Cell Glioblastoma
- Adult Gliosarcoma
- Recurrent Adult Brain Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ziv-aflibercept | Given IV |
| OTHER | pharmacological study | correlative studies |
| OTHER | laboratory biomarker analysis | correlative studies |
Timeline
- Start date
- 2006-08-01
- Primary completion
- 2011-12-01
- Completion
- 2012-10-01
- First posted
- 2006-08-29
- Last updated
- 2015-10-02
- Results posted
- 2015-10-02
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00369590. Inclusion in this directory is not an endorsement.