NCT00253461

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for early_phase_1 lung-cancer

Timeline
Completed

Started Dec 2004

Longer than P75 for early_phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

March 20, 2012

Status Verified

March 1, 2012

Enrollment Period

4.9 years

First QC Date

November 11, 2005

Last Update Submit

March 16, 2012

Conditions

Lung CancerMetastatic CancerOvarian CancerUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV ovarian epithelial cancerstage IV ovarian germ cell tumorextensive stage small cell lung cancerrecurrent small cell lung cancerunspecified adult solid tumor, protocol specificrecurrent ovarian epithelial cancerrecurrent ovarian germ cell tumortumors metastatic to brain

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics on day of positron-emission tomography scan

    Within 1 week of PET

  • Disease response

    after 1-2 courses of treatment

Interventions

computed tomographyPROCEDURE

Within 4 weeks after initial imaging, patients also undergo a CT scan.

positron emission tomographyPROCEDURE

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.

11C topotecanRADIATION

Phase I and II: IV over 10 minutes

fludeoxyglucose F 18RADIATION

Phase II: fludeoxyglucose F 18 IV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsNeoplasm MetastasisOvarian NeoplasmsCarcinoma, Ovarian EpithelialSmall Cell Lung CarcinomaBrain Neoplasms

Interventions

Magnetic Resonance SpectroscopyFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, BronchogenicBronchial NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy SugarsCarbohydrates

Study Officials

  • Raymond Muzic, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

December 1, 2004

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

March 20, 2012

Record last verified: 2012-03

Locations

US(1)