Lung Cancer, Metastatic Cancer, Ovarian Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
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
Brief 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. 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.
Interventions
PROCEDUREcomputed tomography
Within 4 weeks after initial imaging, patients also undergo a CT scan.
PROCEDUREpositron 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.
RADIATION11C topotecan
Phase I and II: IV over 10 minutes
RADIATIONfludeoxyglucose F 18
Phase II: fludeoxyglucose F 18 IV
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics on day of positron-emission tomography scan | Within 1 week of PET |
| Disease response | after 1-2 courses of treatment |
Countries
United States
Outcome results
None listed