Ovarian Cancer Clinical Trial
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.
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Withdrawn |
NCT05201001 -
APX005M in Patients With Recurrent Ovarian Cancer
|
Phase 2 | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156892 -
Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer
|
Phase 1 | |
Suspended |
NCT02432378 -
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines
|
Phase 1/Phase 2 | |
Recruiting |
NCT04533763 -
Living WELL: A Web-Based Program for Ovarian Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT03371693 -
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
|
Phase 3 | |
Withdrawn |
NCT03032614 -
Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
|
Phase 2 | |
Completed |
NCT02019524 -
Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
|
Phase 1 | |
Completed |
NCT01936363 -
Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
|
Phase 2 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
Terminated |
NCT03146663 -
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
|
Phase 2 |