Status:
COMPLETED
Study of Aerosolized Liposomal 9-Nitro-20 (S)- Camptothecin (L9NC)
Lead Sponsor:
University of New Mexico
Conditions:
Lung Diseases
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 pro...
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 min...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00250068
Start Date
April 1 2003
End Date
December 1 2007
Last Update
May 19 2010
Active Locations (1)
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1
University of New Mexico
Albuquerque, New Mexico, United States, 87131