Ignite Creation Date:
2024-05-06 @ 12:31 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01591356
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2012-05-02
Brief Title:
EphA2 siRNA in Treating Patients With Advanced or Recurrent Solid Tumors
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
EphA2 Gene Targeting Using Neutral Liposomal Small Interfering RNA Delivery A Phase I Clinical Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase I trial studies the side effects and best dose of EphA2 siRNA in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment advanced or have come back after a period of improvement recurrent EphA2-targeting DOPC-encapsulated siRNA may slow the growth of tumor cells by shutting down the activity of a gene that causes tumor growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety and tolerability toxicity profile of EphA2-targeting DOPC-encapsulated siRNA EphA2 siRNA delivered via neutral liposome 12-dioleoyl-sn-glycero-3-phosphatidylcholine or DOPC administered intravenously in patients with advancedrecurrent malignancies
II To determine the maximal tolerated dose MTD or maximal administered dose MAD using a modified toxicity probability interval mTPI design
SECONDARY OBJECTIVES
I To determine efficacy EphA2 expression modulation at the MTD or MAD II To evaluate the effect of EphA2 siRNA-DOPC on tumor and endothelial cell apoptosis
III To record the clinical activity objective response duration of response and time to treatment progression of intravenous IV EphA2 siRNA -DOPC
IV To describe the symptom burden of patients receiving siRNA-EphA2-DOPC treatment
EXPLORATORY OBJECTIVES
I To determine the pharmacokinetic profile of siRNA-EphA2-DOPC in blood II To determine the effect of EphA2 siRNA-DOPC on tumor perfusion apparent diffusion and metabolism by radiographic imaging dynamic contrast-enhanced-magnetic resonance imaging DCE-MRI diffusion weighted DW-MRI and fludeoxyglucose F-18-positron emission tomography 18FDG-PET
III To determine the impact of EphA2 siRNA-DOPC on surrogate biomarkers in blood cell-free deoxyribonucleic acid DNA plasmaserum markers vascular endothelial growth factor VEGF caveolin 1 CAV1 soluble EphrinA1 and exosomes
OUTLINE This is a dose-escalation study
Patients receive EphA2-targeting DOPC-encapsulated siRNA IV over 120 minutes on days 1 and 4 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
I To determine the safety and tolerability toxicity profile of EphA2-targeting DOPC-encapsulated siRNA EphA2 siRNA delivered via neutral liposome 12-dioleoyl-sn-glycero-3-phosphatidylcholine or DOPC administered intravenously in patients with advancedrecurrent malignancies
II To determine the maximal tolerated dose MTD or maximal administered dose MAD using a modified toxicity probability interval mTPI design
SECONDARY OBJECTIVES
I To determine efficacy EphA2 expression modulation at the MTD or MAD II To evaluate the effect of EphA2 siRNA-DOPC on tumor and endothelial cell apoptosis
III To record the clinical activity objective response duration of response and time to treatment progression of intravenous IV EphA2 siRNA -DOPC
IV To describe the symptom burden of patients receiving siRNA-EphA2-DOPC treatment
EXPLORATORY OBJECTIVES
I To determine the pharmacokinetic profile of siRNA-EphA2-DOPC in blood II To determine the effect of EphA2 siRNA-DOPC on tumor perfusion apparent diffusion and metabolism by radiographic imaging dynamic contrast-enhanced-magnetic resonance imaging DCE-MRI diffusion weighted DW-MRI and fludeoxyglucose F-18-positron emission tomography 18FDG-PET
III To determine the impact of EphA2 siRNA-DOPC on surrogate biomarkers in blood cell-free deoxyribonucleic acid DNA plasmaserum markers vascular endothelial growth factor VEGF caveolin 1 CAV1 soluble EphrinA1 and exosomes
OUTLINE This is a dose-escalation study
Patients receive EphA2-targeting DOPC-encapsulated siRNA IV over 120 minutes on days 1 and 4 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2015-00745 | REGISTRY | None | None |
| RP120214 | None | None | None |
| NCI-2012-00755 | None | None | None |
| 2011-0216 | OTHER | None | None |
| P50CA093459 | NIH | M D Anderson Cancer Center | httpsreporternihgovquickSearchP50CA093459 |