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11C Topotecan PET Imaging

This study has been terminated.
(Drugs unavailable:unable to make radioactive topotecan)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00253461
First received: November 11, 2005
Last updated: March 16, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention 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
 Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Pharmacokinetics on day of positron-emission tomography scan [ Time Frame: Within 1 week of PET ] [ Designated as safety issue: No ]
  • Disease response [ Time Frame: after 1-2 courses of treatment ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: December 2004
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00253461     History of Changes
Other Study ID Numbers: CWRU6Y02, P30CA043703, CASE-CWRU-6Y02
Study First Received: November 11, 2005
Last Updated: March 16, 2012
Health Authority: United States: Federal Government

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
Neoplasms
Neoplasms, Second Primary
Ovarian Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Endocrine Gland Neoplasms
Ovarian Diseases
 Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013