18F-CP18 Imaging Studies for Cancer Treatment With Birinapant
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|ClinicalTrials.gov Identifier: NCT01766622|
Recruitment Status : Withdrawn
First Posted : January 11, 2013
Last Update Posted : June 20, 2018
- 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.
- To test the effectiveness of 18F-CP18 imaging studies during cancer treatment with Birinapant.
- Individuals at least 18 years of age who are taking Birinapant for ovarian, fallopian tube, or peritoneal cancer.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Neoplasms Ovarian Cancer Fallopian Tube Neoplasms Fallopian Tube Cancer||Drug: [18F]-CP18 Procedure: PET/ CT||Phase 2|
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.
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.
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.
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 30, 2012|
|Actual Primary Completion Date :||July 24, 2013|
|Actual Study Completion Date :||July 24, 2013|
- Drug: [18F]-CP18
7mCi, IV (in the vein) at baseline
- Procedure: PET/ CT
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
- Tumor Uptake [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766622
|Principal Investigator:||Karen A Kurdziel, M.D.||National Cancer Institute (NCI)|