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:
NCT00250068
First received: November 3, 2005
Last updated: May 18, 2010
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Lung Diseases
Cancer
Drug: Liposomal 9-Nitrocamptothecin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • 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). [ Time Frame: disease progression or unacceptable toxicities ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: April 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Liposomal 9-Nitrocamptothecin
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients, 18 years of age or older, with resectable lung cancer (any stage) or stage 3b, 4, or recurrent, nonresectable, non-small-cell lung carcinoma, who have failed standard chemotherapy or radiotherapy for their disease or who refuse standard therapy are eligible.
  • Patients must have a life expectancy of at least 12 weeks.
  • Patients must have a Zubrod performance status of 0-2.
  • Patients must sign an informed consent.
  • Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of >1,500 or cells/mm3 and platelet count >100,000/mm3 and absence of a regular red blood cell transfusion requirement.
  • Patients should have adequate hepatic function with a total bilirubin < 2 mg/dl and SGOT or SGPT < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine < 1.5 x upper limit of normal.
  • Patients must not have a known symptomatic respiratory disease other than cancer, and must have a pulmonary function test equal to >50% FEV1, >50% FEV1/FVC, >50% TLC, and >50% DLCO of predicted values.

Exclusion Criteria:

  • Patients with symptomatic brain metastases are excluded from this study.
  • Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception.
  • Patients may receive no other concurrent chemotherapy or radiation therapy during this trial.
  • Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial.
  • Any criteria that is borderline and may lead to ineligibility will be reviewed by the PI, who may override the eligibility criteria, after receiving sponsor agreement, if entry into the study is deemed to potentially benefit the patient.
  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: NCT00250068

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, MD; Principal Investigator, University of New Mexico
ClinicalTrials.gov Identifier: NCT00250068     History of Changes
Other Study ID Numbers: 1402C
Study First Received: November 3, 2005
Last Updated: May 18, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of New Mexico:
Phase II
Aerosol Delivery
NSCLC
9-Nitrocamptothecin

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
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 October 29, 2014