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Pharmacology Study of Aerosolized Liposomal

Primary Purpose

Lung Diseases, Cancer

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin

About this trial

This is an interventional treatment trial for Lung Diseases focused on measuring NSCLC, L9NC, Aerosolized Liposomal 9-Nitro-20 (S)-Camptothecin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients participating in INST 1402C protocol Phase II Study of Aerosolized Liposomal-Nitro-20 (S)-Camptothecin (L9NC) in Patients with Advanced (NSCLC) Lung Cancer are eligible if their tumor is resectable with curative intent as determined by Dr. Reza Mehran.

Sites / Locations

University of New Mexico

Outcomes

Primary Outcome Measures

Pathological examination of lung tissure

Secondary Outcome Measures

Full Information

NCT ID

NCT00250120

First Posted

November 3, 2005

Last Updated

May 10, 2016

Sponsor

University of New Mexico

1. Study Identification

Unique Protocol Identification Number

NCT00250120

Brief Title

Pharmacology Study of Aerosolized Liposomal

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Withdrawn

Study Start Date

April 2003 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of New Mexico

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To determine the overall response rate to liposomal 9-Nitro-20 (S)-Camptothecin (L9NC) administered by aerosolization in patients with non-small-cell lung cancer (any stage). To determine toxicity profile of L9NC administered by aerosolization for 5 consecutive days per week X 8 weeks, every 10 weeks. To perform a pharmacology study of L9NC in the plasma, and the lungs after aerosolization. A specific protocol will be written for this part.

Detailed Description

This is a single-arm, non-randomized Phase II trial of DLPC-9NC administered by aerosol 5 consecutive days per week for 8 weeks every 10 weeks. Dose: 0.4 mg/ml of 9-NC in aerosol reservoir for 60 minutes (= daily dose of 0.52 mg/m2/day) per day X5 every week, X8 weeks, then observe for 2 weeks. One course = 10 weeks. Patients that have a resectable lung cancer will only receive one course of treatment and will be operated on about two weeks after completing the 8-week course.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Diseases, Cancer

Keywords

NSCLC, L9NC, Aerosolized Liposomal 9-Nitro-20 (S)-Camptothecin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

L9NC: Liposomal 9-Nitro-20 (S)-Camptothecin

Intervention Description

delivery mode: inhalation

Primary Outcome Measure Information:

Title

Pathological examination of lung tissure

Time Frame

at surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claire F Verschraegen, MD

Organizational Affiliation

University of New Mexico

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of New Mexico

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87131

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pharmacology Study of Aerosolized Liposomal

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