11C Topotecan PET Imaging | NCT00253461

Studies
11C Topotecan PET Imaging

NCT00253461

Sponsor

Case Comprehensive Cancer Center

Status

Terminated

Last Update Posted

Mar 20, 2012Estimated

Enrollment

7Actual

Phase

Early Phase 1

Conditions

Lung Cancer
Metastatic Cancer
Ovarian Cancer
Unspecified Adult Solid Tumor, Protocol Specific

Interventions

computed tomography
positron emission tomography
11C topotecan
fludeoxyglucose F 18

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P30CA043703	U.S. NIH Grant/Contract		View source
CASE-CWRU-6Y02	Other Identifier	Case Comprehensive Cancer Center

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Drugs unavailable:unable to make radioactive topotecan

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Nov 11, 2005

First Submission Date that Met QC Criteria

Nov 11, 2005

First Posted Date

Nov 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

Lung Cancer
Metastatic Cancer
Ovarian Cancer
Unspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV ovarian epithelial cancer
stage IV ovarian germ cell tumor
extensive stage small cell lung cancer
recurrent small cell lung cancer
unspecified adult solid tumor, protocol specific
recurrent ovarian epithelial cancer
recurrent ovarian germ cell tumor
tumors metastatic to brain

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
computed tomography	Procedure	Within 4 weeks after initial imaging, patients also undergo a CT scan.
positron emission tomography	Procedure	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.
11C topotecan	Radiation	Phase I and II: IV over 10 minutes
fludeoxyglucose F 18	Radiation	Phase II: fludeoxyglucose F 18 IV

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raymond Muzic, PhD	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center		Cleveland	Ohio	44106-5065	United States

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D009362	Neoplasm Metastasis
D010051	Ovarian Neoplasms
D000077216	Carcinoma, Ovarian Epithelial
D055752	Small Cell Lung Carcinoma
D001932	Brain Neoplasms

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy
D019788	Fluorodeoxyglucose F18

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D003847	Deoxyglucose

Browse Leaves

Not provided

Browse Branches

Not provided