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11C Topotecan PET Imaging
This study has been terminated.
(Drugs unavailable:unable to make radioactive topotecan)
Sponsor:
Case Comprehensive Cancer Center
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
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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 | Early Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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:
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 ]
- Disease response [ Time Frame: after 1-2 courses of treatment ]
| 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:
Detailed Description:
-
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.
Phase I and II: IV over 10 minutes
Radiation: fludeoxyglucose F 18
Phase II: fludeoxyglucose F 18 IV
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) |
| Sexes Eligible for Study: | All |
| 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
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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
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 ( U.S. NIH Grant/Contract ) CASE-CWRU-6Y02 ( Other Identifier: Case Comprehensive Cancer Center ) |
| Study First Received: | November 11, 2005 |
| Last Updated: | March 16, 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 |
ClinicalTrials.gov processed this record on July 26, 2017