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

This study has been completed.
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00250016
First received: November 3, 2005
Last updated: January 6, 2010
Last verified: March 2008
  Purpose

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


Condition
Corpus Uteri
Endometrial Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Further study details as provided by University of New Mexico:

Biospecimen Retention:   Samples Without DNA

Blood sample, tumor endometrial tissue, and normal endometrial tissue.


Enrollment: 6
Study Start Date: August 2003
Study Completion Date: August 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients participating in the trial - "Phase II Study of Aerosolized Liposomal-Nitro-20 (S)-Camptothecin (L9NC) in Patients with Metastatic or Recurrent Cancer of the Endometrium"

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250016

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Claire F Verschraegen, MD University of New Mexico
  More Information

No publications provided

Responsible Party: Claire F. Verschraegen, M.D.; Principal Investigator, University Of New Mexico - CRTC
ClinicalTrials.gov Identifier: NCT00250016     History of Changes
Other Study ID Numbers: 1102C-T
Study First Received: November 3, 2005
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Endometrium
Tissue
L9NC

Additional relevant MeSH terms:
Camptothecin
Rubitecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014