Bevacizumab and Polyethyleneglycol-7-Ethyl-10-Hydroxycamptothecin in Treating Patients With Refractory Solid Tumors
Recruitment status was Recruiting
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as polyethyleneglycol-7-ethyl-10-hydroxycamptothecin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with polyethyleneglycol-7-ethyl-10-hydroxycamptothecin may be an effective treatment for solid tumors.
PURPOSE: This clinical trial is studying how well giving bevacizumab together with polyethyleneglycol-7-ethyl-10-hydroxycamptothecin works in treating patients with refractory solid tumors.
Unspecified Adult Solid Tumor, Protocol Specific
Genetic: protein expression analysis
Other: laboratory biomarker analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Weekly EZN-2208 (PEGylated SN-38) in Combination With Bevacizumab in Refractory Solid Tumors|
- Proportion of patients whose expression of HIF-1α protein declines by 50% compared to baseline [ Designated as safety issue: No ]
- Safety and tolerability of bevacizumab and EZN-2208 [ Designated as safety issue: Yes ]
- Response to bevacizumab and EZN-2208 [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
- Determine the modulation of HIF-1α protein (by ELISA) in patients with refractory solid tumors after treatment with bevacizumab and polyethyleneglycol-7-ethyl-10-hydroxycamptothecin (EZN-2208).
- Determine the safety and tolerability of bevacizumab and EZN-2208 in these patients.
- Perform correlative studies (DCE-MRI and soluble markers) to assess changes in angiogenesis in tumor tissue. (exploratory)
- Evaluate antitumor responses as determined by RECIST.
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 (day -7 of course 1 only) and polyethyleneglycol-7-ethyl-10-hydroxycamptothecin IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection and tumor biopsies at baseline and during study for HIF-1α protein expression and other correlative studies.
After completion of study therapy, patients are followed up for 28 days.
|United States, Maryland|
|NCI - Developmental Therapeutics Clinic||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: Shivaani Kummar, MD 301-435-5402|
|Principal Investigator:||Shivaani Kummar, MD||NCI - Medical Oncology Branch|