NCT00250120

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

3.9 years

First QC Date

November 3, 2005

Last Update Submit

May 10, 2016

Conditions

Lung DiseasesCancer

Keywords

NSCLCL9NCAerosolized Liposomal 9-Nitro-20 (S)-Camptothecin

Outcome Measures

Primary Outcomes (1)

  • Pathological examination of lung tissure

    at surgery

Interventions

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

delivery mode: inhalation

Eligibility Criteria

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Lung DiseasesNeoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Claire F Verschraegen, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

April 1, 2003

Primary Completion

March 1, 2007

Study Completion

August 1, 2007

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

US(1)