11C Topotecan PET Imaging

This study has been terminated.
(Drugs unavailable:unable to make radioactive topotecan)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00253461
First received: November 11, 2005
Last updated: March 16, 2012
Last verified: March 2012

November 11, 2005
March 16, 2012
December 2004
November 2009   (final data collection date for primary outcome measure)
  • Pharmacokinetics on day of positron-emission tomography scan [ Time Frame: Within 1 week of PET ] [ Designated as safety issue: No ]
  • Disease response [ Time Frame: after 1-2 courses of treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00253461 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
11C Topotecan PET Imaging
Positron Emission Tomography Using 11C Topotecan in Predicting Response to Treatment in Patients With Brain Metastases Due to Ovarian, Small Cell Lung, or Other Cancer

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.

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.

Interventional
Phase 0
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Lung Cancer
  • Metastatic Cancer
  • Ovarian Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Procedure: computed tomography
    Within 4 weeks after initial imaging, patients also undergo a CT scan.
  • Procedure: positron emission tomography

    Phase I: IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography (PET) scan.

    Phase II: fludeoxyglucose F 18 IV and, 1 hour later, undergo a PET scan.

  • Radiation: 11C topotecan
    Phase I and II: IV over 10 minutes
  • Radiation: fludeoxyglucose F 18
    Phase II: fludeoxyglucose F 18 IV
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
November 2009
November 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian cancer, small cell lung cancer, or other cancers

    • Metastatic brain disease
  • Eligible for topotecan therapy
  • Measurable disease by CT scan and/or MRI

PATIENT CHARACTERISTICS:

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Not specified

Renal

  • Creatinine clearance ≥ 50 mL/min

Other

  • Not pregnant or nursing
  • Adequate end-organ function
  • Able to tolerate lying on a radiology table for ≥ 1 hour
  • No serious medical or psychiatric illness that would preclude study compliance or giving informed consent

PRIOR CONCURRENT THERAPY: Not specified

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00253461
CWRU6Y02, P30CA043703, CASE-CWRU-6Y02
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Raymond Muzic, PhD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP