Neoplasms Clinical Trial
Official title:
A Phase 1, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor-alpha Positive Pituitary Adenoma
NCT number | NCT02629549 |
Other study ID # | 822782 |
Secondary ID | |
Status | Terminated |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | August 3, 2018 |
Verified date | August 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary end-point of the study is to determine the specificity and sensitivity of OTL38 in identifying pituitary adenomas when excited by an imaging probe. The investigators intend to enroll 50 patients in this study. The study is focusing on patients presenting with suspected pituitary adenomas who are considered to be good surgical candidates.
Status | Terminated |
Enrollment | 33 |
Est. completion date | August 3, 2018 |
Est. primary completion date | August 3, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Adult patients over 18 years of age 2. Patients presenting with a pituitary nodule presumed to be resectable on pre-operative assessment 3. Good operative candidate 4. Subject capable of giving informed consent and participating in the process of consent. Exclusion Criteria: 1. Pregnant women as determined by urinary or serum beta human chorionic gonadotropin (hCG) within 72 hours of surgery 2. Patients with a history of anaphylactic reactions to OTL38 3. Patients with a known allergy to Benadryl 4. Previous exposure to OTL38 |
Country | Name | City | State |
---|---|---|---|
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
Berkmann S, Schlaffer S, Nimsky C, Fahlbusch R, Buchfelder M. Follow-up and long-term outcome of nonfunctioning pituitary adenoma operated by transsphenoidal surgery with intraoperative high-field magnetic resonance imaging. Acta Neurochir (Wien). 2014 Dec;156(12):2233-43; discussion 2243. doi: 10.1007/s00701-014-2210-x. Epub 2014 Sep 2. — View Citation
Dorward NL. Endocrine outcomes in endoscopic pituitary surgery: a literature review. Acta Neurochir (Wien). 2010 Aug;152(8):1275-9. doi: 10.1007/s00701-010-0649-y. Epub 2010 May 10. Review. — View Citation
Evans CO, Reddy P, Brat DJ, O'Neill EB, Craige B, Stevens VL, Oyesiku NM. Differential expression of folate receptor in pituitary adenomas. Cancer Res. 2003 Jul 15;63(14):4218-24. — View Citation
Evans CO, Yao C, Laborde D, Oyesiku NM. Folate receptor expression in pituitary adenomas cellular and molecular analysis. Vitam Horm. 2008;79:235-66. doi: 10.1016/S0083-6729(08)00408-1. — View Citation
Feng Y, Shen J, Streaker ED, Lockwood M, Zhu Z, Low PS, Dimitrov DS. A folate receptor beta-specific human monoclonal antibody recognizes activated macrophage of rheumatoid patients and mediates antibody-dependent cell-mediated cytotoxicity. Arthritis Res Ther. 2011 Apr 8;13(2):R59. doi: 10.1186/ar3312. — View Citation
Hilgenbrink AR, Low PS. Folate receptor-mediated drug targeting: from therapeutics to diagnostics. J Pharm Sci. 2005 Oct;94(10):2135-46. Review. — View Citation
Kennedy MD, Jallad KN, Thompson DH, Ben-Amotz D, Low PS. Optical imaging of metastatic tumors using a folate-targeted fluorescent probe. J Biomed Opt. 2003 Oct;8(4):636-41. — View Citation
Liu X, Ma S, Yao Y, Li G, Feng M, Deng K, Dai C, Cai F, Li Y, Zhang B, Wang R. Differential expression of folate receptor alpha in pituitary adenomas and its relationship to tumor behavior. Neurosurgery. 2012 May;70(5):1274-80; discussion 1280. doi: 10.1227/NEU.0b013e3182417e76. — View Citation
Low PS, Antony AC. Folate receptor-targeted drugs for cancer and inflammatory diseases. Adv Drug Deliv Rev. 2004 Apr 29;56(8):1055-8. Review. — View Citation
Lu Y, Sega E, Leamon CP, Low PS. Folate receptor-targeted immunotherapy of cancer: mechanism and therapeutic potential. Adv Drug Deliv Rev. 2004 Apr 29;56(8):1161-76. Review. — View Citation
Lu Y, Xu LC, Parker N, Westrick E, Reddy JA, Vetzel M, Low PS, Leamon CP. Preclinical pharmacokinetics, tissue distribution, and antitumor activity of a folate-hapten conjugate-targeted immunotherapy in hapten-immunized mice. Mol Cancer Ther. 2006 Dec;5(12):3258-67. — View Citation
Paulos CM, Reddy JA, Leamon CP, Turk MJ, Low PS. Ligand binding and kinetics of folate receptor recycling in vivo: impact on receptor-mediated drug delivery. Mol Pharmacol. 2004 Dec;66(6):1406-14. Epub 2004 Sep 15. — View Citation
Stephenson SM, Low PS, Lee RJ. Folate receptor-mediated targeting of liposomal drugs to cancer cells. Methods Enzymol. 2004;387:33-50. — View Citation
Swearingen B. Update on pituitary surgery. J Clin Endocrinol Metab. 2012 Apr;97(4):1073-81. doi: 10.1210/jc.2011-3237. Epub 2012 Feb 15. Review. — View Citation
Sylvester PT, Evans JA, Zipfel GJ, Chole RA, Uppaluri R, Haughey BH, Getz AE, Silverstein J, Rich KM, Kim AH, Dacey RG, Chicoine MR. Combined high-field intraoperative magnetic resonance imaging and endoscopy increase extent of resection and progression-free survival for pituitary adenomas. Pituitary. 2015 Feb;18(1):72-85. doi: 10.1007/s11102-014-0560-2. — View Citation
Xia W, Low PS. Folate-targeted therapies for cancer. J Med Chem. 2010 Oct 14;53(19):6811-24. doi: 10.1021/jm100509v. Review. — View Citation
Yang J, Chen H, Vlahov IR, Cheng JX, Low PS. Characterization of the pH of folate receptor-containing endosomes and the rate of hydrolysis of internalized acid-labile folate-drug conjugates. J Pharmacol Exp Ther. 2007 May;321(2):462-8. Epub 2007 Feb 8. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection of OTL38 in tumor tissue. | The detection of OTL38 uptake by tumor tissue will be made with the use of an imaging system that detects the presence of dye in tissue. | 60 months | |
Primary | Evaluate the ability of OTL38 to discern between tumorous tissue and normal, neural tissue. | Specificity and sensitivity of OTL38 will be calculated through the comparison of the video images gathered from the imaging system and the final pathology results from the surgical procedure. | 60 months | |
Secondary | Incidence rates of all adverse events, treatment-emergent adverse events and adverse device events from time of OTL38 administration through participants' first, post-operative appointment with surgeon. | 60 months |
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