Trial Outcomes & Findings for A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer (NCT NCT01773889)

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Response = CR + PR. Failure to respond criteria are not based on RECIST criteria, which have unclear application to immune-based clinical trials. Instead, novel lack-of-failure criteria, rather than failure-of-success criteria have been written to avoid stopping therapy prematurely without compromising patient safety, to accommodate the uncertainties of assessing failure in this setting. The criteria as written are based on sound medical, scientific and ethical principles. The trial is further designed to help establish the utility of these novel criteria.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

2 participants

Primary outcome timeframe

every 3 months until the date of first documented progression or date of death from any cause, assessed up to 2 years when study terminated early

Results posted on

2018-04-10

Participant Flow

This study was open to accrual on 7/29/2009 and closed to accrual on 6/27/2011. Subjects were seen at The Cancer Therapy and Research Center @ The University of Texas Health Science Center San Antonio.

* Intercurrent illness that prevents further administration of treatment * Unacceptable adverse event(s) * Patient withdraws from study * General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator.

Participant milestones

Participant milestones
Measure	Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
Overall Study lack of funding	2

Baseline Characteristics

A Trial of Intravenous Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A in Stage III or IV Ovarian Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A n=2 Participants Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: every 3 months until the date of first documented progression or date of death from any cause, assessed up to 2 years when study terminated early

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Response = CR + PR. Failure to respond criteria are not based on RECIST criteria, which have unclear application to immune-based clinical trials. Instead, novel lack-of-failure criteria, rather than failure-of-success criteria have been written to avoid stopping therapy prematurely without compromising patient safety, to accommodate the uncertainties of assessing failure in this setting. The criteria as written are based on sound medical, scientific and ethical principles. The trial is further designed to help establish the utility of these novel criteria.

Outcome measures

Outcome measures
Measure	Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A n=2 Participants Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
Clinical Response Rate	2 participants

Adverse Events

Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tyler Curiel, MD

The Cancer and Therapy Center at The University of Texas Health Science Center San Antonio

Phone: 210-562-5287

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place