18F-CP18 Imaging Studies for Cancer Treatment With Birinapant

NCT01766622 | Withdrawn Phase 2

• 2 other identifiers: 13003613-C-0036
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ovarian Neoplasms; Ovarian Cancer; Fallopian Tube Neoplasms; Fallopian Tube Cancer

Keywords

Apoptosis; Pro-Apoptotic Effects; PET Imaging; TL32711; Relapsed Platinum Resistant or Refractory Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor Uptake

  2 years

Interventions

[18F]-CP18 DRUG

7mCi, IV (in the vein) at baseline

PET/ CT PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Related Publications (3)

• 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.

  PMID: 10647931 BACKGROUND

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

  PMID: 11999952 BACKGROUND

• 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.

  PMID: 20651737 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

CP-18 compound; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Karen A Kurdziel, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 11, 2013
• Study Start: November 30, 2012
• Primary Completion: July 24, 2013
• Study Completion: July 24, 2013
• Last Updated: December 4, 2019

Record last verified: 2013-07-24