11C Topotecan PET Imaging

Early Phase 1

Terminated

• Conditions: Lung Cancer; Metastatic Cancer; Ovarian Cancer; Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00253461
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET scan) using 11C topotecan, may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase I/II trial is studying how well a PET scan using 11C topotecan predicts response to treatment in patients with brain metastases due to ovarian, small cell lung, or other cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine if tumor uptake of \^11C topotecan occurs quickly enough and at sufficient concentration to be measured immediately following infusion in patients with brain metastases secondary to ovarian cancer, small cell lung cancer, or other cancers.

* Determine, preliminarily, if \^11C imaging has potential to be an early predictor of response to topotecan therapy in these patients.

Secondary

* Determine the whole-body biodistribution of \^11C topotecan in these patients.

OUTLINE:

* Phase I: Patients receive \^11C topotecan IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography (PET) scan. Within 4 weeks after initial imaging, patients also undergo a CT scan.

* Phase II: Patients receive \^11C topotecan and undergo imaging as in phase I. Patients also receive fludeoxyglucose F 18 IV and, 1 hour later, undergo a PET scan.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-11-11
• Study First Submitted QC: 2005-11-11
• Study First Posted: 2005-11-15
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-16
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics on day of positron-emission tomography scan	Within 1 week of PET
Disease response	after 1-2 courses of treatment

Trial Locations

Locations (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States