Brief Title
18F-CP18 Imaging Studies for Cancer Treatment With Birinapant
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
Brief 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. 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.
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Tumor Uptake
Condition
Ovarian Neoplasms
Intervention
[18F]-CP18
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
November 30, 2012
Completion Date
July 24, 2013
Primary Completion Date
July 24, 2013
Eligibility Criteria
- 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
Gender
Female
Ages
18 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
Karen A Kurdziel, M.D., ,
Administrative Informations
NCT ID
NCT01766622
Organization ID
130036
Secondary IDs
13-C-0036
Responsible Party
Sponsor
Study Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Karen A Kurdziel, M.D., Principal Investigator, National Cancer Institute (NCI)
Verification Date
July 24, 2013