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11C Topotecan PET Imaging

Primary Purpose

Lung Cancer, Metastatic Cancer, Ovarian Cancer

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
computed tomography
positron emission tomography
11C topotecan
fludeoxyglucose F 18
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Outcomes

Primary Outcome Measures

Pharmacokinetics on day of positron-emission tomography scan
Disease response

Secondary Outcome Measures

Full Information

First Posted
November 11, 2005
Last Updated
March 16, 2012
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00253461
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Drugs unavailable:unable to make radioactive topotecan
Study Start Date
December 2004 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Description
Within 4 weeks after initial imaging, patients also undergo a CT scan.
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
11C topotecan
Intervention Description
Phase I and II: IV over 10 minutes
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Intervention Description
Phase II: fludeoxyglucose F 18 IV
Primary Outcome Measure Information:
Title
Pharmacokinetics on day of positron-emission tomography scan
Time Frame
Within 1 week of PET
Title
Disease response
Time Frame
after 1-2 courses of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Muzic, PhD
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States

12. IPD Sharing Statement

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11C Topotecan PET Imaging

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