18F-CP18 Imaging Studies for Cancer Treatment With Birinapant

December 3, 2019 updated by: National Institutes of Health Clinical Center (CC)

A Pilot Study of [18F]-CP18 PET/CT Imaging in Patients With Relapsed Platinum Resistant or Refractory Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer Therapy Receiving Birinapant, a SMAC Mimetic Therapy

Background:

- 18F-CP18 is a chemical designed for use in imaging studies. It is attracted to tumor cells that are being killed by cancer treatment. Researchers want to test it in imaging studies for people who are being treated with Birinapant. Birinapant is a drug used to treat advanced ovarian, fallopian tube, or peritoneal cancers. It works kills tumor cells that have not responded to earlier treatment. 18F-CP18 may help to monitor cancer treatments with this drug.

Objectives:

- To test the effectiveness of 18F-CP18 imaging studies during cancer treatment with Birinapant.

Eligibility:

- Individuals at least 18 years of age who are taking Birinapant for ovarian, fallopian tube, or peritoneal cancer.

Design:

  • Participants will have a brief physical exam. They will also answer questions about their medical history and any current medications.
  • Participants will receive a dose of 18F-CP18, followed by an imaging study. The study will involve a positron emission tomography/computed tomography (PET/CT) scan. The scan will last 40 minutes.
  • There will be two more PET/CT scans 1 hour and 2 hours after taking 18F-CP18. These scans will look at how the tumor cells absorb and process 18F-CP18.
  • This is a scanning study only. No treatment will be provided as part of this study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Detailed Description

Background:

Dysregulation of apoptosis is instrumental in forming the malignant phenotype and is associated with resistance to chemotherapeutics and biological therapies. Cleaved Caspase 3 (its activated form) plays a key role in the common apoptotic pathway.

CP18 is an enzyme substrate of caspase 3. The formulation [18F]-CP18 includes PEG vector which facilitates internalization and can be non-invasively imaged using PET. Once cleaved into polar fragments by caspase 3, it become trapped within the cells.

In a phase 2 NCI clinical trial (NCI Protocol (#12C0191) CTEP 9235), Birinapant (TL32711), a SMAC (second mitochondrial derived activator of caspase) mimetic, is being evaluated in patients with relapsed platinum resistant or refractory epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

PET/CT imaging with [18F]-CP18 may enable the non-invasive, in vivo monitoring of this drugs pro-apoptotic effects. If a measureable effect is shown in this pilot study, further evaluation of [18F]-CP18 PET/CT s potential to monitor apoptosis may be warranted.

Primary Objective:

To determine tumor uptake and retention of [18F]-CP18 before and after treatment with a SMAC mimetic (Birinapant, TL32711), in patients with relapsed platinum resistant or refractory epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

Eligibility:

All subjects must meet the eligibility criteria for the phase 2 study of Birinapant (NCI Protocol (#12C0191) CTEP 9235) and be enrolled in or planning to enroll in parent therapy protocol

All subjects must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.

Design:

This is a pilot study to assess the change in [18F]-CP18 PET tumor uptake following treatment with Birinapant, a SMAC mimetic drug, in patients with relapsed platinum resistant or refractory epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer. Subjects will undergo at least 3 [18F]-CP18 PET/CT imaging studies,one pre-therapy, one within 48 hours after receiving the initial dose of Birinapant, and a third scan within 48 hours after receiving cycle 2, day 15 dose of Birinapant and prior to the tumor biopsy on the same day. An exploration of the relationship between PET imaging parameters and clinical response and various biomarkers (as determined under the referring protocol) will also be performed. Ten patients will be enrolled on this protocol.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  • INCLUSION CRITERIA

Subjects with pathology proven epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer that are relapsed or refractory to prior platinum-based standard care systemic regimen, enrolled, or eligible to be enrolled in the Phase 2 NCI protocol treatment using Birinapant (NCI Protocol (#12C0191)CTEP 9235); therefore must meet the inclusion criteria for that study

Ability to provide informed consent. All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of this study before any protocol related studies are performed.

EXCLUSION CRITERIA

Known allergy to any of the formulation components of [18F]-CP18.

The subject is pregnant or nursing

Participants for whom enrollment would significantly delay (> 2 weeks) the scheduled standard of care therapy.

Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded.

Participants with severe claustrophobia not relieved by oral anxiolytic medication or patients weighing >136 kg (weight limit for scanner table).

Other medical conditions deemed by the PI or associates to make the patient ineligible for protocol procedures.

It is likely that all patients in this study will be surgically sterile. If this is not the case, the patient must have a negative serum beta HCG within 24 hour prior to PET/CT or be post-menopausal for greater than or equal to 2 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Tumor Uptake
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institutes of Health Clinical Center (CC)

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karen A Kurdziel, M.D., National Cancer Institute (NCI)

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 24, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 130036
  • 13-C-0036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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