Lung CancerEarly Phase 1NCT00253461
11C Topotecan PET Imaging
A Early Phase 1 study testing computed tomography, positron emission tomography and 11C topotecan in people with Lung Cancer and Metastatic Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Metastatic Cancer, Ovarian Cancer
- What is being tested?
- computed tomography, positron emission tomography and 11C topotecan
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Nov 2009
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
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
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.
Read the 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
- Lung Cancer, Metastatic Cancer, Ovarian Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- computed tomography, positron emission tomography, 11C topotecan, fludeoxyglucose F 18
- 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
- Medical subject headings
- Lung Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Small Cell Lung Carcinoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyProcedure or surgery
Within 4 weeks after initial imaging, patients also undergo a CT scan.
positron emission tomographyProcedure or surgery
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 topotecanRadiation
Phase I and II: IV over 10 minutes
fludeoxyglucose F 18Radiation
Phase II: fludeoxyglucose F 18 IV
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics on day of positron-emission tomography scan
Measured: Within 1 week of PET
Disease response
Measured: after 1-2 courses of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startDec 2004
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Drugs unavailable:unable to make radioactive topotecan
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Raymond Muzic, PhD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253461
- Sponsor's protocol ID
- CWRU6Y02
- Other IDs
- P30CA043703, CASE-CWRU-6Y02
- Status last verified
- Mar 2012
- First submitted
- 11 Nov 2005
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00253461
- Acronym / sponsor ID
- CWRU6Y02
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Drugs unavailable:unable to make radioactive topotecan
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2004
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomographyWithin 4 weeks after initial imaging, patients also undergo a CT scan. | Procedure or surgery | – |
| positron emission tomographyPhase 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. | Procedure or surgery | – |
| 11C topotecanPhase I and II: IV over 10 minutes | Radiation | – |
| fludeoxyglucose F 18Phase II: fludeoxyglucose F 18 IV | Radiation | – |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Drugs unavailable:unable to make radioactive topotecan). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Muzic, PhD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing computed tomography, positron emission tomography and 11C topotecan in people with Lung Cancer and Metastatic Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Drugs unavailable:unable to make radioactive topotecan). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics on day of positron-emission tomography scan (time frame: Within 1 week of PET). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2012.