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Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

OTL38

Near infrared camera imaging system

Laparotomy

About this trial

This is an interventional other trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female patients 18 years of age and older
Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary debulking or interval debulking surgery, and:
- Who are scheduled to undergo laparotomy for the debulking surgery OR
- Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery, if cancer is detected on the laparoscopy
A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

Exclusion Criteria:

Previous exposure to OTL38
Known FR alpha-negative ovarian cancer
Planned surgical approach via laparoscopy or robotic surgery
Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
History of anaphylactic reactions or severe allergies
History of allergy to any of the components of OTL38, including folic acid
Pregnancy, or positive pregnancy test
Clinically significant abnormalities on electrocardiogram (ECG)
Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Impaired renal function defined as eGFR< 50 mL/min/1.73m2
Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
Known Stage IV ovarian cancer with Brain Metastases
Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery
Known sensitivity to fluorescent light

Sites / Locations

University of CA at Irvine Chao Cancer Center
Moffitt Cancer Center
Mayo Clinic-Rochester
University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients Receiving OTL38

Arm Description

All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.

Outcomes

Primary Outcome Measures

Sensitivity of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.

Sensitivity for the detection of folate receptor-alpha positive (FRAP) ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAO ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by the pathology/ and immunohistochemistry lab (TP+FN). 95% lower one-sided confidence interval was used.

Positive Predictive Value (PPV) of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.

PPV for the detection of FRAP ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAP ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by fluorescent light (TP + FP). 95% lower one-sided confidence interval was used.

Secondary Outcome Measures

Full Information

NCT ID

NCT02317705

First Posted

November 18, 2014

Last Updated

May 24, 2022

Sponsor

On Target Laboratories, LLC

Collaborators

SynteractHCR

1. Study Identification

Unique Protocol Identification Number

NCT02317705

Brief Title

Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer

Official Title

A Phase 2, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

On Target Laboratories, LLC

Collaborators

SynteractHCR

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study is being done to: test the safety of OTL38 see if OTL38 helps light up the cancer when viewed with the special camera system test the safety of the special camera system for use along with OTL38 during surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients Receiving OTL38

Arm Type

Experimental

Arm Description

All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.

Intervention Type

Drug

Intervention Name(s)

OTL38

Other Intervention Name(s)

OTL38 for Injection, CYTALUX™ (pafolacianine) injection

Intervention Type

Device

Intervention Name(s)

Near infrared camera imaging system

Intervention Description

Near infrared camera imaging system

Intervention Type

Procedure

Intervention Name(s)

Laparotomy

Intervention Description

primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Primary Outcome Measure Information:

Title

Sensitivity of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.

Description

Time Frame

Day of Surgery (Day 1)

Title

Positive Predictive Value (PPV) of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.

Description

Time Frame

Day of Surgery (Day 1)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female patients 18 years of age and older Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary debulking or interval debulking surgery, and: Who are scheduled to undergo laparotomy for the debulking surgery OR Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery, if cancer is detected on the laparoscopy A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments Exclusion Criteria: Previous exposure to OTL38 Known FR alpha-negative ovarian cancer Planned surgical approach via laparoscopy or robotic surgery Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient History of anaphylactic reactions or severe allergies History of allergy to any of the components of OTL38, including folic acid Pregnancy, or positive pregnancy test Clinically significant abnormalities on electrocardiogram (ECG) Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule Impaired renal function defined as eGFR< 50 mL/min/1.73m2 Impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin. Known Stage IV ovarian cancer with Brain Metastases Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery Known sensitivity to fluorescent light

Facility Information:

Facility Name

University of CA at Irvine Chao Cancer Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Moffitt Cancer Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Mayo Clinic-Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23450588

Citation

Al Rawahi T, Lopes AD, Bristow RE, Bryant A, Elattar A, Chattopadhyay S, Galaal K. Surgical cytoreduction for recurrent epithelial ovarian cancer. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD008765. doi: 10.1002/14651858.CD008765.pub3.

Results Reference

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PubMed Identifier

21647742

Citation

Crane LM, Arts HJ, van Oosten M, Low PS, van der Zee AG, van Dam GM, Bart J. The effect of chemotherapy on expression of folate receptor-alpha in ovarian cancer. Cell Oncol (Dordr). 2012 Feb;35(1):9-18. doi: 10.1007/s13402-011-0052-6. Epub 2011 Jun 7. Erratum In: Cell Oncol (Dordr). 2012 Jun;35(3):229.

Results Reference

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PubMed Identifier

20065732

Citation

Ibeanu OA, Bristow RE. Predicting the outcome of cytoreductive surgery for advanced ovarian cancer: a review. Int J Gynecol Cancer. 2010 Jan;20 Suppl 1:S1-11. doi: 10.1111/IGC.0b013e3181cff38b.

Results Reference

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PubMed Identifier

18222534

Citation

Kalli KR, Oberg AL, Keeney GL, Christianson TJ, Low PS, Knutson KL, Hartmann LC. Folate receptor alpha as a tumor target in epithelial ovarian cancer. Gynecol Oncol. 2008 Mar;108(3):619-26. doi: 10.1016/j.ygyno.2007.11.020. Epub 2008 Jan 28.

Results Reference

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PubMed Identifier

8387781

Citation

Leamon CP, Low PS. Membrane folate-binding proteins are responsible for folate-protein conjugate endocytosis into cultured cells. Biochem J. 1993 May 1;291 ( Pt 3)(Pt 3):855-60. doi: 10.1042/bj2910855.

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PubMed Identifier

19189636

Citation

Markert S, Lassmann S, Gabriel B, Klar M, Werner M, Gitsch G, Kratz F, Hasenburg A. Alpha-folate receptor expression in epithelial ovarian carcinoma and non-neoplastic ovarian tissue. Anticancer Res. 2008 Nov-Dec;28(6A):3567-72.

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PubMed Identifier

15745749

Citation

Parker N, Turk MJ, Westrick E, Lewis JD, Low PS, Leamon CP. Folate receptor expression in carcinomas and normal tissues determined by a quantitative radioligand binding assay. Anal Biochem. 2005 Mar 15;338(2):284-93. doi: 10.1016/j.ab.2004.12.026.

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PubMed Identifier

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Citation

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PubMed Identifier

20613895

Citation

Shih KK, Chi DS. Maximal cytoreductive effort in epithelial ovarian cancer surgery. J Gynecol Oncol. 2010 Jun;21(2):75-80. doi: 10.3802/jgo.2010.21.2.75. Epub 2010 Jun 30.

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PubMed Identifier

9583724

Citation

Toffoli G, Russo A, Gallo A, Cernigoi C, Miotti S, Sorio R, Tumolo S, Boiocchi M. Expression of folate binding protein as a prognostic factor for response to platinum-containing chemotherapy and survival in human ovarian cancer. Int J Cancer. 1998 Apr 17;79(2):121-6. doi: 10.1002/(sici)1097-0215(19980417)79:23.0.co;2-v.

Results Reference

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PubMed Identifier

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Citation

van Dam GM, Themelis G, Crane LM, Harlaar NJ, Pleijhuis RG, Kelder W, Sarantopoulos A, de Jong JS, Arts HJ, van der Zee AG, Bart J, Low PS, Ntziachristos V. Intraoperative tumor-specific fluorescence imaging in ovarian cancer by folate receptor-alpha targeting: first in-human results. Nat Med. 2011 Sep 18;17(10):1315-9. doi: 10.1038/nm.2472.

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Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer

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