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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


Phase 0
18 Years
N/A
Not Enrolling
Both
Lung Cancer, Metastatic Cancer, Ovarian Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Pharmacokinetics on day of positron-emission tomography scan

Outcome Time Frame:

Within 1 week of PET

Safety Issue:

No

Principal Investigator

Raymond Muzic, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CWRU6Y02

NCT ID:

NCT00253461

Start Date:

December 2004

Completion Date:

November 2009

Related Keywords:

  • Lung Cancer
  • Metastatic Cancer
  • Ovarian Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • Lung Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Ovarian Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065