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NCT00250016 Clinical Trial

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

Endometrial Cancer Clinical Trial

Official title:
1102C-T. Pharmacology Study of Aerosolized Liposomal-Nitro-20 (S)-Camptothecin (L9NC) in Patients With Metastatic or Recurrent Cancer of the Endometrium. Tissue Submission for Patients With Endometrial Cancer.

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00250016
Other study ID # 1102C-T
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date August 2003
Est. completion date August 2007

Study information
Verified date December 2023
Source University of New Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date August 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of New Mexico Albuquerque New Mexico

Sponsors (1)
Lead Sponsor Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

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