11C Topotecan PET Imaging

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Lung Cancer, Metastatic Cancer, Ovarian Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Procedure: computed tomography
* Procedure: positron emission tomography
* Radiation: 11C topotecan
* Radiation: fludeoxyglucose F 18


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|
|Radiation: 11C topotecan|Phase I and II: IV over 10 minutes|
|Radiation: fludeoxyglucose F 18|Phase II: fludeoxyglucose F 18 IV|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics on day of positron-emission tomography scan |  | Within 1 week of PET | 
| Disease response |  | after 1-2 courses of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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