Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)
This study has been completed.
Sponsor:
University of New Mexico
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
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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) |
Resource links provided by NLM:
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:
Detailed Description:
-
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
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
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 9-nitrocamptothecin Topoisomerase I Inhibitors Topoisomerase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 18, 2013