11C Topotecan PET Imaging

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Terminated; Early Phase 1

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

Treatments: Radiation: 11C topotecan; Procedure: positron emission tomography; Radiation: fludeoxyglucose F 18; Procedure: computed tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00253461

CWRU6Y02

P30CA043703 (U.S. NIH Grant/Contract)

CASE-CWRU-6Y02 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)