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Ovarian NeoplasmsPhase 2NCT01766622

18F-CP18 Imaging Studies for Cancer Treatment With Birinapant

A Phase 2 study testing [18F]-CP18 and PET/ CT in people with Ovarian Neoplasms and Ovarian Cancer, run by National Institutes of Health Clinical Center (CC).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 99 years, women only
What is being tested?
[18F]-CP18 and PET/ CT
How many people
0 participants
Where
No sites listed yet
Study dates
30 Nov 2012to 24 Jul 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

About this study

Official title: 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.
Read more

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.
Read the 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.

Being tested
[18F]-CP18, PET/ CT
Keywords
Apoptosis, Pro-Apoptotic Effects, PET Imaging, TL32711, Relapsed Platinum Resistant or Refractory Epithelial Ovarian Cancer
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]-CP18Drug

    7mCi, IV (in the vein) at baseline

  • PET/ CTProcedure or surgery

    At baseline, Within 3 days after the initial Birinapant dose, A third [18F]-CP18 PET/CT will be obtained within 3 days following cycle 2, day 15 Birinapant therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor Uptake

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2013 (estimated)
  2. Study start30 Nov 2012
  3. Primary completion24 Jul 2013
  4. Study completion24 Jul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01766622
Sponsor's protocol ID
130036
Other IDs
13-C-0036
Status last verified
24 Jul 2013
First submitted
10 Jan 2013
Last updated
4 Dec 2019
Results posted
No

Publications

  • Hanahan D, Weinberg RA. The hallmarks of cancer. Cell. 2000 Jan 7;100(1):57-70. doi: 10.1016/s0092-8674(00)81683-9. No abstract available.

    PubMed 10647931

  • Green AM, Steinmetz ND. Monitoring apoptosis in real time. Cancer J. 2002 Mar-Apr;8(2):82-92. doi: 10.1097/00130404-200203000-00002.

    PubMed 11999952

  • Gyrd-Hansen M, Meier P. IAPs: from caspase inhibitors to modulators of NF-kappaB, inflammation and cancer. Nat Rev Cancer. 2010 Aug;10(8):561-74. doi: 10.1038/nrc2889.

    PubMed 20651737

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [18F]-CP18 and PET/ CT in people with Ovarian Neoplasms and Ovarian Cancer, run by National Institutes of Health Clinical Center (CC).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor Uptake (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01766622, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.

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