11C Topotecan PET Imaging

Early Phase 1TerminatedNCT00253461

Case Comprehensive Cancer Center7 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

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

Interventions

computed tomographyPROCEDURE

Within 4 weeks after initial imaging, patients also undergo a CT scan.

positron emission tomographyPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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