Clinical trial NCT00253461: 11C Topotecan PET Imaging
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-11-15
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Pharmacokinetics on day of positron-emission tomography scan
timeFrame: Within 1 week of PET
measure: Disease response
timeFrame: after 1-2 courses of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Raymond Muzic, PhD
role: PRINCIPAL_INVESTIGATOR
References: