Phase I Intratumoral Pbi-shRNA STMN1 LP in Advanced and/or Metastatic Cancer (STMN1-LP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01505153|
Recruitment Status : Completed
First Posted : January 6, 2012
Last Update Posted : February 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer Metastatic Cancer Solid Tumors||Biological: pbi-shRNA STMN1 LP||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Intratumoral Bi-functional shRNA Stathmin 1-knockdown Lipoplex in Patients With Advanced and/or Metastatic Cancer|
|Actual Study Start Date :||February 2012|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||April 13, 2017|
Experimental: pbi-shRNA STMN1 LP
pbi-shRNA™ STMN1 LP administered by a single intratumoral (IT) injection.
Biological: pbi-shRNA STMN1 LP
This is a Phase I safety trial of bifunctional shRNA-STMN1 (pbi-shRNA™STMN1) BIV (bilamellar invaginated vesicle) lipoplex (LP), pbi-shRNA™ STMN1 LP administered by a single intratumoral (IT) injection. Patients will accrue in 4-patient escalation cohorts using a modified Fibronacci escalation schema at a starting intratumoral dose of 0.010 mg/kg of DNA through a dose of 0.053 mg/kg DNA intratumoral / single dose.
- To determine the safety of intratumoral administration of pbi-shRNA™ STMN1 LP [ Time Frame: 1 month ]To determine the safety of intratumoral administration of pbi-shRNA™ STMN1 LP in patients with superficial advanced and/or metastatic cancer who have no acceptable form of standard therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505153
|United States, Texas|
|Mary Crowley Cancer Research Centers|
|Dallas, Texas, United States, 75230|
|Principal Investigator:||Minal Barve, MD||Mary Crowley Cancer Research Centers|