MedDataX Logo

Pharmacology Study of Aerosolized Liposomal 9-Nitro-20 (S)-Camptothecin (L9NC)

NCT ID: NCT00250016

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2003-08-31

Study Completion Date

2007-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the amount of Aerosolized Liposomal-Nitro-20 (S)-Camptothecin (L9NC) in a patients blood and tumor.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients on this study are being asked to allow the researchers to take a piece of some normal endometrial tissue and tumor tissue. No additional endometrial tissue will be taken for this study other than what is surgically indicated to resect the patients tumor completely. Prior to this surgery, patients will receive one more dose of L9NC in the outpatient clinic in the same manner as the other L9NC treatments they have received. After the tumor has been removed, the tissue will be examined by a pathologist, who will take what is needed to diagnose the residual disease. What is not needed for patient care will be used for research. A piece of the tumor and some normal endometrial tissue surrounding the tumor will be sent to the Investigational Drug Program laboratory, which is located in the Cancer Center, to measure the amount of drug that is left in the patients tumor. The patients tissue will be kept until all tissues are collected from all patients, which could take up to 10 years. The tissue will not be used for any other purpose. The samples will be labeled with the patients initials.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Corpus Uteri Endometrial Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Endometrium Tissue L9NC

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients participating in Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC) in Patients with Metastatic or Recurrent Cancer of the Endometrium are eligible.

Exclusion Criteria

* Not specified.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University Of New Mexico - CRTC

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Claire F Verschraegen, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1102C-T

Identifier Type: -

Identifier Source: org_study_id