11C Topotecan PET Imaging
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ClinicalTrials.gov Identifier: NCT00253461 |
Recruitment Status
:
Terminated
(Drugs unavailable:unable to make radioactive topotecan)
First Posted
: November 15, 2005
Last Update Posted
: March 20, 2012
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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 or disease | Intervention/treatment | 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 | Early Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | December 2004 |
Actual Primary Completion Date : | November 2009 |
Actual Study Completion Date : | November 2009 |

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Procedure: computed 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.
- Pharmacokinetics on day of positron-emission tomography scan [ Time Frame: Within 1 week of PET ]
- Disease response [ Time Frame: after 1-2 courses of treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253461
United States, Ohio | |
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 |
Principal Investigator: | Raymond Muzic, PhD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
Responsible Party: | Case Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT00253461 History of Changes |
Other Study ID Numbers: |
CWRU6Y02 P30CA043703 ( U.S. NIH Grant/Contract ) CASE-CWRU-6Y02 ( Other Identifier: Case Comprehensive Cancer Center ) |
First Posted: | November 15, 2005 Key Record Dates |
Last Update Posted: | March 20, 2012 |
Last Verified: | March 2012 |
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 |