18F-CP18 Imaging Studies for Cancer Treatment With Birinapant

NCT01766622WithdrawnPHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

National Institutes of Health Clinical Center (CC)

Enrollment

0

Start Date

2012-11-30

Completion Date

2013-07-24

Study Type

INTERVENTIONAL

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

Interventions

[18F]-CP18PET/ CT

Conditions

Ovarian NeoplasmsOvarian CancerFallopian Tube NeoplasmsFallopian Tube Cancer

Eligibility

Age Range

18 Years – 99 Years

Sex

FEMALE

* 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

Outcome Measures

Primary Outcomes

Tumor Uptake

Time frame: 2 years