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11C Topotecan PET Imaging

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ClinicalTrials.gov Identifier: NCT00253461
Recruitment Status : Terminated (Drugs unavailable:unable to make radioactive topotecan)
First Posted : November 15, 2005
Last Update Posted : March 20, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lung Cancer Metastatic Cancer Ovarian Cancer Unspecified Adult Solid Tumor, Protocol Specific Procedure: computed tomography Procedure: positron emission tomography Radiation: 11C topotecan Radiation: fludeoxyglucose F 18 Early Phase 1

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : December 2004
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Procedure: computed tomography
    Within 4 weeks after initial imaging, patients also undergo a CT scan.
    Procedure: positron 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.

    Radiation: 11C topotecan
    Phase I and II: IV over 10 minutes
    Radiation: fludeoxyglucose F 18
    Phase II: fludeoxyglucose F 18 IV

Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics on day of positron-emission tomography scan [ Time Frame: Within 1 week of PET ]
  2. Disease response [ Time Frame: after 1-2 courses of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253461


Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Raymond Muzic, PhD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00253461     History of Changes
Other Study ID Numbers: CWRU6Y02
P30CA043703 ( U.S. NIH Grant/Contract )
CASE-CWRU-6Y02 ( Other Identifier: Case Comprehensive Cancer Center )
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: March 20, 2012
Last Verified: March 2012

Keywords provided by Case Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
 Pathologic Processes
Topotecan
Fluorodeoxyglucose F18
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Radiopharmaceuticals