11C Topotecan PET Imaging

This study has been terminated.

(Drugs unavailable:unable to make radioactive topotecan)

Sponsor:

Collaborator:

National Cancer Institute (NCI)

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

History of Changes

Purpose

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.

Condition	Intervention	Phase
Lung Cancer Metastatic Cancer Ovarian Cancer Unspecified Adult Solid Tumor, Protocol Specific	Procedure: computed tomography Procedure: positron emission tomography Radiation: 11C topotecan Radiation: fludeoxyglucose F 18	Phase 0


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer ovarian cancer

MedlinePlus related topics: Cancer

Drug Information available for: Fludeoxyglucose F 18 Topotecan hydrochloride Topotecan

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer Ovarian Germ Cell Tumor

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:

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 ]


Enrollment:	7
Study Start Date:	December 2004
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Within 4 weeks after initial imaging, patients also undergo a CT scan.

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.

Phase I and II: IV over 10 minutes

Phase II: fludeoxyglucose F 18 IV

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00253461

Locations


United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Raymond Muzic, PhD	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

More Information


Responsible Party:	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00253461 History of Changes
Other Study ID Numbers:	CWRU6Y02 P30CA043703 CASE-CWRU-6Y02
Study First Received:	November 11, 2005
Last Updated:	March 16, 2012
Health Authority:	United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:


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

Additional relevant MeSH terms:


Lung Neoplasms Neoplasm Metastasis Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Neoplastic Processes	Pathologic Processes Topotecan Fluorodeoxyglucose F18 Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Radiopharmaceuticals

ClinicalTrials.gov processed this record on September 23, 2016

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