Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
EARLY_PHASE1
7 participants
INTERVENTIONAL
2004-12-31
2009-11-30
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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computed tomography
Within 4 weeks after initial imaging, patients also undergo a CT scan.
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.
11C topotecan
Phase I and II: IV over 10 minutes
fludeoxyglucose F 18
Phase II: fludeoxyglucose F 18 IV
Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Case Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Raymond Muzic, PhD
Role: PRINCIPAL_INVESTIGATOR
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Locations
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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CASE-CWRU-6Y02
Identifier Type: OTHER
Identifier Source: secondary_id
CWRU6Y02
Identifier Type: -
Identifier Source: org_study_id
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